DE102012000430A1 - Topical composition, useful to avoid and/or reduce scar formation, comprises onion extract and panthenol and/or its derivatives, preferably esters and/or pantothenic acid and/or its salt - Google Patents

Abstract

Topical composition comprises (a) onion extract and (b) panthenol and/or its derivatives, preferably esters and/or pantothenic acid and/or its salt. An independent claim is included for a container containing the composition, preferably in the form of a tube, bottle, can, pump and/or dosing device or syringe, where the composition is preferably at least in sterile form, hence present in the sterile container. ACTIVITY : Vulnerary. MECHANISM OF ACTION : None given.

Description

The present invention relates to the medical field of urology, in particular the field of urological, in particular transurethral interventions or operations.

In particular, the present invention relates to a composition which is preferably suitable for the topical treatment of the urethra during surgical or transurethral procedures. Furthermore, the present invention relates to a container containing the composition according to the invention. Moreover, the present invention relates to the use of the composition according to the invention.

The urinary organs (Organia urinia) designate a group of organs which serve for the formation and excretion of urine. Together with the sex organs, the urinary organs are summarized as genitourinary tract. The urinary organs include in humans and in most vertebrates kidneys, ureters, urinary bladder and urethra. The urine formed in the kidneys arrives at the urinary bladder via the ureter. The output to the outside finally takes place via the urethra.

The urethra is a membranous, muscular tube lined with urothelium from the inside. From the inside to the outside follow on the urothelium elastic connective tissue and a blood vessel network, which in turn are surrounded by smooth muscle. The embedding of the urethra in the surrounding tissue is carried out by another outer connective tissue. In women, the urethra is only about 2.5 to 5 cm long, whereas the male urethra has a length of about 20 to 25 cm.

The urethra, especially the inner layer of urothelium, is extremely sensitive, so that it can come due to external mechanical influences as well as due to endogenous causes, such as inflammation, to injuries or changes to the tissue.

Injuries to the urethra as a result of operations or transurethral interventions, for example in the removal of diseased or to be examined tissue from the bladder or prostate, for example in the case of bladder carcinomas, bladder diverticula or benign tumors of the prostate, are particularly common. In such a transurethral resection z. B. a wire loop over which an electric current flows, introduced through the urethra into the bladder; the tissue is removed layer by layer and bleeding is subsequently electrically eroded. The introduction of urological instruments and the resulting friction on the urothelium can lead to lesions on the urothelial layer.

Catheterizations for urinary diversion also often lead to injuries to the urethra. Catheterizations may be required due to acute conditions such as urinary tract infections or urinary retention, after surgery, or due to chronic dysfunctions such as bladder dysfunction or urinary incontinence. Especially in permanent catheterizations, the urothelium is often severely damaged by the foreign body.

In addition, inflammation, in particular triggered by bacterial infections inflammation, lead to changes or injuries of the urethral tissue or urothelium.

The problem of lesions or changes in the urethral urothelium is the formation of hardening and scarring. Due to the raised structure of scars, a urethra narrowing or a so-called urethral stricture can be formed. The stronger the constriction, the greater the pressure that must be exerted for voiding (micturition), so that it often leads to the retention of residual urine in the bladder. In extreme cases, the consequence of a urethral stricture may be a complete urinary retention, i. H. the urinary bladder can not be emptied spontaneously. On the one hand, urinary retention is extremely painful and, on the other hand, it can trigger a backflow of urine into the kidneys, which can damage them due to pressure.

For the treatment of urethral strictures surgical procedures are generally required. Urethrotomy - also known as urethral slit - is an endoscopic procedure in which a small incision is made in the area of the constriction. However, this method is only applicable to constrictions over a length of 1 to 4 cm. In long-lasting urethral strictures, the use of sculptures becomes necessary, whereby first oral mucosa is taken from the inside of the upper lip or the cheek and then sewn as an extension into the urethra. For short urethral narrowing of less than 2 cm, the narrowed section may also be operative be removed. The two ends are then desolated together. However, a disadvantage of such surgical interventions is that they are associated with a high risk of infection and moreover are very painful for the patient. Furthermore, they are expensive to carry out and generally require inpatient hospitalization.

As an alternative to the aforementioned surgical measures, bougienage may also be used. H. a mechanical dilation or dilatation - the urethra done. For this purpose, rods of increasing thickness are introduced into the urethra, which each remain in the urethra for a period of several weeks, so that there is an expansion of the urethra. Also, a bougienage of the urethra is very painful for the patient, especially when using thicker rods. In addition, the long treatment period of several weeks in total is extremely impractical and tedious.

Overall, the aforementioned measures for the treatment of urethral strictures often do not lead to the desired success. On the one hand, they are complex in use and on the other hand associated with a high recurrence rate, so they often have to be repeated several times. In addition, they are extremely painful for the person affected and require long-term follow-up care or treatment.

In the treatment of urethral strictures, it would be desirable to have conservative measures that can prevent scarring or reduce existing scarring, thus reducing the need for surgical or surgical procedures.

Thus, the present invention has for its object to provide a new concept for the treatment of urethral strictures, which avoids the aforementioned disadvantages of the prior art at least partially or at least partially mitigates.

In particular, the object of the present invention is to provide, with regard to the treatment of urethral strictures, easy-to-use or topical measures which at least partially avoid or at least partially mitigate the aforementioned disadvantages of the prior art.

It is a further object of the present invention to provide a composition suitable for topical treatment of the urethra in operative and / or transurethral procedures, which serves to prevent and / or reduce scarring.

To achieve the object described above, the present invention proposes a composition according to claim 1; Further advantageous embodiments are the subject of the relevant dependent claims.

Another object of the present invention is a container containing the composition of the invention according to the relevant independent claim.

Finally, the subject of the present invention is the use of the composition according to the invention according to the relevant independent claims.

It goes without saying that the following special embodiments, embodiments or the like, which are described only in connection with an aspect of the invention, apply mutatis mutandis in relation to the other aspects of the invention without this expressly needs mention.

Furthermore, it must be noted in the context of the present invention that those skilled in the art should select each of the abovementioned relative or percentage, in particular weight-related quantities, that the sum of the respective ingredients, active ingredients, additives or auxiliaries or the like is always 100%. result. This is understood by the skilled person but by itself.

Incidentally, the person skilled in the art may deviate from the number, range or quantity information given below, based on the application or the individual case, without departing from the scope of the present invention.

In addition, it is true that all the parameter information or the like mentioned below can in principle be determined or determined using standardized or explicitly stated determination methods or else determination methods familiar to the person skilled in the art.

• (a) Zwiebelextrakt (Extrakt Bulbus cepae) (”Komponente (a)”) und
• (b) Panthenol und/oder dessen Derivate, insbesondere Ester, und/oder Pantothensäure und/oder deren physiologisch unbedenkliche Salze (”Komponente (b)”)

umfasst. The present invention is thus - according to a first aspect of the invention - a composition, in particular a pharmaceutical composition, which is particularly suitable for the prevention and / or reduction of scarring, in particular for the topical treatment of the urethra in surgical and / or transurethral procedures, where the composition - in each case effective, in particular pharmaceutically effective amounts - as active ingredients, in particular in combination,

• (a) Onion extract (extract Bulbus cepae) ("component (a)") and
• (b) panthenol and / or its derivatives, in particular esters, and / or pantothenic acid and / or their physiologically acceptable salts ("component (b)")

includes.

The Applicant has surprisingly found that can be significantly reduced by the particular synergistic combination of onion extract on the one hand and panthenol or pantothenic acid on the other scarring, especially in the urethra, after transurethral or surgical procedures or already existing scars can be reduced. In this context, it has been found, in particular, that the individual active ingredients complement each other in a synergistic manner, since the effect of the combination according to the invention goes beyond the action of the individual active ingredients in a significant manner.

The terms "pharmaceutical composition", "pharmaceutical preparation" or the like as used in the present invention are to be understood as being very comprehensive and not only pharmaceutical preparations but also so-called medical products, homeopathic agents, cosmetics or the like ,

The active substance onion extract used according to the invention, also referred to as "extract Bulbus cepae" or "Extractum cepae", is, in particular, an active-ingredient-containing extract obtained from so-called kitchen onions (botanical Allium cepa). Onion extract is rich in essential oils, sulfur compounds and flavonoids, especially quercetin, and has a scar-reducing effect. It is assumed in the context of the present invention that the scar reduction is triggered by an inhibition or reduction of the fibroblast proliferation. In addition, onion extract has an antiproliferative effect, so that the uncontrolled formation of new tissue is prevented during the application of the composition according to the invention. In addition, onion extract has antimicrobial, anti-inflammatory and antioxidant effects.

As far as the active ingredient "panthenol" is concerned, for the purposes of the present invention this is understood to mean a chemical compound which belongs to the polyols and amides and has the systematic name 2,4-dihydroxy-N- (3-hydroxypropyl) -3,3- carries dimethylbutyramide. According to the invention, "panthenol" also means panthenol derivatives, such as esters. In particular, D (+) - panthenol, colloquially also referred to as dexpanthenol, is used in the context of the present invention. The active ingredient develops in the context of the treatment according to the invention in particular a wound healing promoting effect. Panthenol is enzymatically converted to pantothenic acid in the body, which is also known as vitamin B5 and, as a component of coenzyme A, plays a central role in skin metabolism. Consequently, in the context of the present invention, pantothenic acid, in which it is chemically N- (2,4-dihydroxy-3,3-dimethyl 1-oxobutyl) -beta-alanine, wherein according to the invention the (R) -form is particularly preferred; In particular, pantothenic acid in the form of its physiologically acceptable salts can be used within the scope of the composition according to the invention.

The absorption of panthenol or pantothenic acid after topical application increases the moisture retention capacity and, as a consequence, also the elasticity of the treated skin or mucous membrane. Panthenol or pantothenic acid also supports the formation of the treated mucosal cells within the scope of the present invention, resulting in faster regeneration of damaged tissue. In addition, panthenol and pantothenic acid have anti-inflammatory and antipruritic effects. For further details of the active ingredient (b) can be particularly referred to Römpp Chemielexikon, 10th edition, 1999, Georg Thieme Verlag, Stuttgart / New York, keywords "Panthenol" and "Dexpanthenol", pages 927 and 3107-3108 , as well as the literature referenced therein, the content of which is hereby incorporated by reference in its entirety.

In the context of the present invention it was completely surprising that onion extract on the one hand and panthenol on the other hand in relation to the reduction or reduction of scar formation, in particular in surgical and / or transurethral interventions, in terms of their effectiveness in such a way synergistic, that the need for surgical or surgical procedures for the treatment of urethral strictures due to scarring can be significantly reduced or reduced.

The present invention also has many other advantages and features that distinguish it from the prior art and are described in detail below.

In particular, the composition according to the invention is particularly uncomplicated in its application and handling, in particular in comparison with the methods known from the prior art for the treatment of urethral strictures, since it is generally applied purely topically. In addition, the use of the composition of the invention is associated with significantly less inconvenience to the patient, such as pain, long term treatment, or spontaneous complications.

Furthermore, the recurrence rate with respect to the repeated occurrence of urethral strictures is reduced with the composition according to the invention, since - without wishing to be limited to this theory - the cause of urethral strictures (namely, scarring, especially on the urothelium) is already combated before it is formed.

The composition according to the invention also effectively prevents the occurrence of urinary tract infections or inflammations, in particular after transurethral interventions, since the combination of onion extract and panthenol according to the invention, in addition to the scar-reducing effect, also has outstanding anti-inflammatory and antimicrobial properties. The additional optional use of fusafungin in the composition, these effects can be further increased, as described below.

Another particularly advantageous feature of the composition according to the invention lies in the acceleration of the regeneration of the tissue, in particular of the urothelium, after transurethral interventions. This effect can even be enhanced by the additional optional use of Ectoin, as described below.

Furthermore, the composition in question is characterized by its particularly good compatibility, since the ingredients are generally free of side effects. In fact, onion extract is a purely herbal natural substance which is at least substantially free of chemical modifications and generally does not cause any allergic reactions or intolerances in humans. Panthenol or pantothenic acid as vitamin B5 is also free of side effects.

In connection with the advantages and special features described above, reference is already made at this point to the efficacy studies carried out by the applicant, which demonstrate the aforementioned effects in an impressive manner and are described in detail below.

The present invention may be embodied in many ways, with preferred embodiments described in detail below for better understanding.

With regard to the scar-reducing effect, the use of extracts with a high drug / extract ratio has proved to be particularly effective as regards component (a) or the onion extract in detail. The drug / extract ratio (DEV) is a fixed pharmaceutical term, which is used in particular in connection with phytopharmaceuticals and indicates the necessary starting amount of drug for the preparation of a certain amount of the extract. For an extract with a drug / extract ratio of 10: 1, this means that 1 part of the extract is obtained from 10 parts of the drug. With regard to a high concentration of active ingredient, it is therefore advantageous if the extract used has a high drug / extract ratio or an extract with a high drug / extract ratio is used. In the context of the present invention, it has proved to be particularly advantageous if the onion extract used has a drug / extract ratio in the range from 0.1: 1 to 100: 1, in particular in the range from 0.5: 1 to 50: 1, preferably in the range of 1: 1 to 25: 1.

As far as the amount of onion extract used (cephalic extract extract) is concerned, this can vary widely. For good efficacy, however, it has proved to be particularly advantageous if the composition of onion extract in an amount in the range of 0.0001 to 5 wt .-%, in particular in Range of 0.001 to 2.5 wt .-%, preferably in the range of 0.01 to 2 wt .-%, preferably in the range of 0.05 to 1 wt .-%, based on the composition contains.

Moreover, it may be provided according to the invention that the composition of onion extract (extract Bulbus cepae) in an absolute amount in the range of 0.1 to 1000 mg, in particular in the range of 1 to 500 mg, preferably in the range of 2 to 250 mg, is preferred in the range of 3 to 100 mg, more preferably in the range of 5 to 80 mg, even more preferably in the range of 10 to 50 mg, wherein the abovementioned derived amounts are based in particular on an application unit and / or in particular on an application amount.

An application unit or an application amount is to be understood in particular as meaning the amount of composition according to the invention which is used in the context of a single treatment (unit), in particular of the urethra. In this context, it may also be provided, in particular, that the composition according to the invention as an application unit or with the appropriate amount of application is already present in a container, for example a syringe, for single use.

As regards the component (b) or panthenol and / or its derivative (s) and / or pantothenic acid or its physiologically acceptable salts, the amount used can also vary within wide ranges. With regard to the effectiveness, in particular the support of the urothelium in the regeneration, it has proved to be particularly efficient when the composition of the invention, the component (b) (ie panthenol and / or its derivative (s), in particular esters, and / or Pantothenic acid and / or physiologically acceptable salts thereof) in an amount in the range of 0.0001 to 10 wt .-%, in particular in the range of 0.001 to 9 wt .-%, preferably in the range of 0.01 to 8 wt .-% , preferably in the range of 0.1 to 6.5 wt .-%, particularly preferably in the range of 1 to 5 wt .-%, most preferably in the range of 1.5 to 3 wt .-%, based, based the composition.

In order to achieve a particularly efficient activity of component (b), it has moreover proved advantageous if panthenol in the form of dexpanthenol is present in the composition. Dexpanthenol is the biologically active form of panthenol, which is enzymatically converted into pantothenic acid (vitamin B5) after being ingested by contact with the skin in the body.

In view of the synergistic effect of onion extract on the one hand and panthenol on the other hand, it has proved to be particularly effective when component (a) and component (b) have a weight-related ratio of [(a) :( b)] in the range of 1 : 1 to 100: 1, in particular in the range of 1.2: 1 to 80: 1, preferably in the range of 2: 1 to 60: 1, preferably in the range of 3: 1 to 30: 1, particularly preferably in the range of 4: 1 to 20: 1, most preferably in the range of 5: 1 to 15: 1, are present in the composition.

According to a particularly preferred embodiment of the present invention, it may also be provided that the composition contains fusafungin and / or a fusafungin derivative ("component (c)") as further component (c).

Fusafungin is a natural antibiotic which is synthesized by fungi of the genus Fusarium, in particular of the species Fusarium lateritium, preferably WR strain 437, or other Fusarium species. From a chemical point of view, fusafungin is a heat-stable depsipeptide. It is an ionophore peptide antibiotic which is a mixture of ennitatin A, B, C and optionally other components; Enniantins are cyclic depsipeptides with a ring-shaped peptide and ester bond backbone. Fusafungine is a solid which melts at 125 to 129 ° C, is almost insoluble in water but soluble in glycols and fats.

Fusafungin has hitherto been used in the prior art only for the treatment of upper respiratory tract infections. The Applicant has surprisingly found that in the context of the inventive composition Fusafungin or its derivatives in combination with the other active ingredients develops a particularly good effect and surprisingly enhances the effect of the two basic components - onion extract and panthenol or pantothenic acid.

Fusafungin is particularly effective against Gram-positive bacteria, such as streptococci, pneumococci and staphylococci, but also against Gram-negative bacteria and moreover against the fungus Candida albicans and against cell-wallless mycoplasma. The bacteriostatic or bactericidal effect of Fusafungin is based - without wishing to be bound by any particular theory - on the ionophore properties of the antibiotic, which increases the permeability of the membrane of pathogens for sodium and potassium ions due to its function as an alkalizing transporter and in this way the ion concentration gradient vital for the bacteria is reduced. In addition to the bacteriostatic or bactericidal action, fusafungin also has an anti-inflammatory effect within the scope of the composition according to the invention. Derivatives of fusafungin are to be understood as meaning, in particular, its physiologically tolerated salts and its esters, esters and amides. For further details on the active ingredient "fusafungin" can be referenced, for example Römpp Chemielexikon, 10th edition, 1999, Georg Thieme Verlag, Stuttgart / New York, keyword "Fusafungin", page 1442 , as well as the literature referenced therein, the content of which is hereby incorporated by reference in its entirety.

In the context of the present invention, it has surprisingly been found that fusafungine on the one hand and the combination of onion extract and panthenol or pantothenic acid on the other hand complement each other in a synergistic manner in their action. The antimicrobial and antiinflammatory properties of onion extract are further enhanced by the additional use of fusafungin, in particular the overall effect of all the above-mentioned active ingredients when applied together is significantly beyond the effect of the respective individual active ingredients.

As far as the amounts of fusafungin used are concerned, these are also variable. It has proven to be particularly effective if the composition fusafungin and / or at least one fusafungin derivative in an amount in the range of 0.0001 to 5 wt .-%, in particular in the range of 0.001 to 3 wt .-%, preferably in the range of 0.01 to 2 wt .-%, preferably in the range of 0.1 to 1 wt .-%, based on the composition.

Furthermore, it can be inventively provided that the composition fusafungin and / or at least one Fusafunginderivat in an absolute amount in the range of 0.1 to 1000 mg, in particular in the range of 1 to 500 mg, preferably in the range of 5 to 250 mg, preferred in the range from 10 to 100 mg, particularly preferably in the range from 20 to 80 mg, very particularly preferably in the range from 30 to 70 mg, wherein the aforementioned amounts are based in particular on an application unit and / or in particular on an application amount.

In order to achieve a particularly efficient effect, it is particularly advantageous if the components "onion extract" (component (a)) and "fusafungin" (component (b)) are contained in a specific weight-related ratio in the composition. In this connection, it may in particular be provided that the composition comprises component (a) and component (c) in a weight-related ratio of [(a) :( c)] in the range from 1:10 to 10: 1, in particular Range of 1: 5 to 5: 1, preferably in the range of 1: 4 to 4: 1, preferably in the range of 1: 3 to 3: 1, particularly preferably in the range of 1: 2 to 2: 1 contains.

According to a further preferred embodiment of the present invention, it may additionally be provided that the composition contains ectoine and / or at least one ectoine derivative ("component (d)") as further component (d). The active substance ectoine is in the composition according to the invention, in particular with regard to a further acceleration of the regeneration of the urothelium after transurethral or surgical intervention of advantage.

The component ectoine used in the present invention is chemically (4S) -2-methyl-1,4,5,6-tetrahydropyrimidine-4-carboxylic acid according to the following structural formula:

The ectoine used according to the invention is a natural substance belonging to the group of compatible solutes and has strongly water-binding properties. Ectoin occurs in halo or extremophilic bacteria. Without wishing to be bound by theory, Ectoin stabilizes the natural structure of biopolymers, such as proteins, nucleic acids and biomembranes, and protects the skin or mucosa from damage. Ectoin ensures a sustainable hydration, especially when used on mucous membranes. For further explanations in this regard with regard to ectoine, in particular with regard to its preparation, reference may be made to the European patent specification EP 0 887 418 B1 the entire disclosure of which is hereby incorporated by reference.

The amount of ectoine used is equally variable. Particularly good results with regard to the effectiveness of the composition according to the invention are obtained when the composition contains ectoine and / or at least one ectoine derivative in an amount in the range from 0.0001 to 10% by weight, in particular in the range from 0.001 to 9% by weight. %, preferably in the range of 0.01 to 8 wt .-%, preferably in the range of 0.1 to 6.5 wt .-%, particularly preferably in the range of 1.5 to 3 wt .-%, based on the Composition containing.

In this connection it is furthermore preferred if ectoin or the at least one ectoine derivative in the form of hydroxyectoine is present in the composition.

As regards the further embodiment, in particular the basic substances or carrier substances, of the composition according to the invention, this is variable. Preferred embodiments are described below.

In view of the consistency of the composition according to the invention, it is advantageous if the composition has a viscous and / or pasty consistency. It is particularly preferred with regard to uncomplicated applicability when the composition is present as an ointment, cream, paste, gel or the like, in particular as a gel.

In order to further improve the applicability in the urethra, it may be provided according to the invention in particular that the composition has a Brookfield viscosity at a temperature of 25 ° C. in the range of 500 to 100,000 mPas, in particular in the range of 750 to 50,000 mPas, preferably in Range of from 1,000 to 10,000 mPas, more preferably in the range of 1,500 to 8,000 mPas, most preferably in the range of 2,000 to 6,000 mPas. By setting viscosities in the abovementioned ranges, the composition according to the invention on the one hand sufficiently low viscosity, to allow easy applicability without exerting great pressure. On the other hand, good adhesion to the urothelium is nevertheless achieved, so that the active components are in contact with the urothelium for a longer period of time and can be absorbed to develop their effect.

Moreover, it is advantageous if the composition of the invention has a physiologically acceptable pH. In particular, it may be provided in this connection that the composition according to the invention has a pH in the range from 3 to 8, in particular in the range from 4 to 7.5, preferably in the range from 5 to 7, particularly preferably in the range from 6 to 7 , having.

Furthermore, it can be provided in the context of the present invention that the composition according to the invention has an electrical conductivity in the physiological range. In this regard, it is particularly advantageous if the electrical conductivity is in the range of 1 to 20 mS / cm, in particular in the range of 2 to 15 mS / cm, preferably in the range of 5 to 15 mS / cm.

As far as the further embodiment of the composition according to the invention is concerned, it is usually provided that the composition is aqueous or aqueous-alcoholic.

In this context, it has proved to be particularly advantageous if the composition comprises at least one preferably polyhydric alcohol.

As regards the preferably polyhydric alcohol in particular, it may be selected from the group of polyvinyl alcohols, glycerol, glycols and (poly) alkylene glycols and combinations and mixtures thereof, preferably alkylene or polyalkylene glycols, more preferably (poly) propylene glycol. Most preferably, the polyhydric alcohol is propylene glycol.

The amounts of the preferably polyhydric alcohol used can vary within wide limits. It has proven to be particularly advantageous if the composition comprises the preferably polyhydric alcohol in an amount in the range from 10 to 80% by weight, in particular in the range from 15 to 70% by weight, preferably in the range from 20 to 60% by weight. , based on the composition contains.

In addition, it can usually be provided in the context of the present invention that the composition contains water, in particular in an amount of at least 10 wt .-%, in particular at least 20 wt .-%, preferably at least 30 wt .-%, based on the Composition. In particular, the composition may contain water in an amount in the range from 10 to 90% by weight, in particular in the range from 20 to 85% by weight, preferably from 30 to 80% by weight, based on the composition.

With regard to the adjustment of the desired consistency or viscosity of the composition according to the invention, it may also be provided that the composition has at least one gelling agent.

As regards the gelling agent in particular, it may be advantageously selected from the group consisting of bentonites, silicic acids, polyacrylic acids, carbomers, polyvinylpyrrolidones, cellulose and cellulose derivatives, xanthanes and mixtures thereof, preferably cellulose and cellulose derivatives. In particular, the gelling agent may be selected from modified celluloses, in particular chemically modified celluloses, more preferably methylcellulose, hydroxymethylcellulose, caroxymethylcellulose and / or hydroxyethylcellulose. Particularly good results are achieved when the gelling agent is hydroxymethylcellulose.

The amounts of gelling agent used can vary within the scope of the present invention within a wide range. Usually, the composition may contain the gelling agent in amounts ranging from 0.01 to 20% by weight, in particular in the range from 0.1 to 10% by weight, preferably in the range from 0.5 to 5% by weight, preferably 1 to 3 wt .-%, based on the composition.

In order to keep the pH of the composition according to the invention constant, in particular within the scope of its application, it is preferred according to the invention if the composition contains at least one acid and / or base, in particular for the formation of a buffer system. In this context, it may be provided that the composition contains at least one buffer system. In particular, it is advantageous if the composition preferably has at least one base; In this case, the base may preferably be selected from the group of amines, carboxylates, alkali metal and / or alkaline earth metal hydroxides and mixtures thereof and combinations, in particular alkali metal and alkaline earth metal hydroxides, preferably sodium hydroxide.

Moreover, it can be inventively provided that the composition comprises at least one other active ingredient and / or ingredient, which may be selected in particular from the group of skin protection agents, antiseptics, local anesthetics, vitamins, trace elements, minerals, micronutrients and combinations thereof.

In particular, in the context of the present invention, it can additionally be provided that the composition contains at least one customary pharmaceutical adjunct and / or adjuvant, which can in particular be selected from the group of processing aids, stabilizers, emulsifiers, antioxidants, preservatives, humectants, pH adjusters , pH buffering agents, thickening agents, antiseptics, colorants, buffers, fragrances, fragrances, stretchers, binders, wetting agents and / or preservatives and combinations thereof.

• (a) Zwiebelextrakt (Extrakt Bulbus cepae) in einer Menge im Bereich von 0,0001 bis 5 Gew.-%, insbesondere im Bereich von 0,001 bis 2,5 Gew.-%, vorzugsweise im Bereich von 0,01 bis 2 Gew.-%, bevorzugt im Bereich von 0,05 bis 1 Gew.-%, bezogen auf die Zusammensetzung,
• (b) Panthenol und/oder dessen Derivate, insbesondere Ester, und/oder Pantothensäure und/oder deren physiologisch unbedenkliche Salze in einer Menge im Bereich von 0,0001 bis 10 Gew.-%, insbesondere im Bereich von 0,001 bis 9 Gew.-%, vorzugsweise im Bereich von 0,01 bis 8 Gew.-%, bevorzugt im Bereich von 0,1 bis 6,5 Gew.-%, besonders bevorzugt im Bereich von 1 bis 5 Gew.-%, ganz besonders bevorzugt im Bereich von 1,5 bis 3 Gew.-%, bezogen auf die Zusammensetzung,
• (c) gegebenenfalls Fusafungin und/oder mindestens ein Fusafunginderivat in einer Menge im Bereich von 0,0001 bis 5 Gew.-%, insbesondere im Bereich von 0,001 bis 3 Gew.-%, vorzugsweise im Bereich von 0,01 bis 2 Gew.-%, bevorzugt im Bereich von 0,1 bis 1 Gew.-%, bezogen auf die Zusammensetzung,

aufweist.According to a particularly preferred embodiment, the subject matter of the invention is a composition, in particular a pharmaceutical composition, which is particularly suitable for the prevention and / or reduction of scarring, preferably for the topical treatment of the urethra during operative and / or transurethral procedures. in each case effective, in particular pharmaceutically effective amounts - as active ingredients, in particular in combination,

• (a) Onion extract (Bulb cepae extract) in an amount in the range of 0.0001 to 5% by weight, in particular in the range of 0.001 to 2.5% by weight, preferably in the range of 0.01 to 2% by weight. %, preferably in the range from 0.05 to 1% by weight, based on the composition,
• (b) panthenol and / or its derivatives, in particular esters, and / or pantothenic acid and / or physiologically acceptable salts thereof in an amount in the range from 0.0001 to 10% by weight, in particular in the range from 0.001 to 9% by weight. %, preferably in the range of 0.01 to 8 wt .-%, preferably in the range of 0.1 to 6.5 wt .-%, particularly preferably in the range of 1 to 5 wt .-%, most preferably in the range from 1.5 to 3% by weight, based on the composition,
• (c) optionally fusafungin and / or at least one fusafungin derivative in an amount in the range of 0.0001 to 5 wt .-%, in particular in the range of 0.001 to 3 wt .-%, preferably in the range of 0.01 to 2 wt. %, preferably in the range from 0.1 to 1% by weight, based on the composition,

having.

• (a) Zwiebelextrakt (Extrakt Bulbus cepae) in einer Menge im Bereich von 0,0001 bis 5 Gew.-%, insbesondere im Bereich von 0,001 bis 2,5 Gew.-%, vorzugsweise im Bereich von 0,01 bis 2 Gew.-%, bevorzugt im Bereich von 0,05 bis 1 Gew.-%, bezogen auf die Zusammensetzung,
• (b) Panthenol und/oder dessen Derivate, insbesondere Ester, und/oder Pantothensäure und/oder deren physiologisch unbedenkliche Salze in einer Menge im Bereich von 0,0001 bis 10 Gew.-%, insbesondere im Bereich von 0,001 bis 9 Gew.-%, vorzugsweise im Bereich von 0,01 bis 8 Gew.-%, bevorzugt im Bereich von 0,1 bis 6,5 Gew.-%, besonders bevorzugt im Bereich von 1 bis 5 Gew.-%, ganz besonders bevorzugt im Bereich von 1,5 bis 3 Gew.-%, bezogen auf die Zusammensetzung,
• (c) gegebenenfalls Fusafungin und/oder mindestens ein Fusafunginderivat in einer Menge im Bereich von 0,0001 bis 5 Gew.-%, insbesondere im Bereich von 0,001 bis 3 Gew.-%, vorzugsweise im Bereich von 0,01 bis 2 Gew.-%, bevorzugt im Bereich von 0,1 bis 1 Gew.-%, bezogen auf die Zusammensetzung,
• (d) gegebenenfalls Ectoin und/oder mindestens ein Ectoinderivat, insbesondere Hydroxyectoin, in einer Menge im Bereich von 0,0001 bis 10 Gew.-%, insbesondere im Bereich von 0,001 bis 9 Gew.-%, vorzugsweise im Bereich von 0,01 bis 8 Gew.-%, bevorzugt im Bereich von 0,1 bis 6,5 Gew.-%, besonders bevorzugt im Bereich von 1,5 bis 3 Gew.-%, bezogen auf die Zusammensetzung,

aufweist.According to a further particularly preferred embodiment, the subject of the invention is a composition, in particular a pharmaceutical composition, which is particularly suitable for the prevention and / or reduction of scarring, preferably for the topical treatment of the urethra during operative and / or transurethral procedures. in each case effective, in particular pharmaceutically effective amounts - as active ingredients, in particular in combination,

• (a) Onion extract (Bulb cepae extract) in an amount in the range of 0.0001 to 5% by weight, in particular in the range of 0.001 to 2.5% by weight, preferably in the range of 0.01 to 2% by weight. %, preferably in the range from 0.05 to 1% by weight, based on the composition,
• (b) panthenol and / or its derivatives, in particular esters, and / or pantothenic acid and / or physiologically acceptable salts thereof in an amount in the range from 0.0001 to 10% by weight, in particular in the range from 0.001 to 9% by weight. %, preferably in the range of 0.01 to 8 wt .-%, preferably in the range of 0.1 to 6.5 wt .-%, particularly preferably in the range of 1 to 5 wt .-%, most preferably in the range from 1.5 to 3% by weight, based on the composition,
• (c) optionally fusafungin and / or at least one fusafungin derivative in an amount in the range of 0.0001 to 5 wt .-%, in particular in the range of 0.001 to 3 wt .-%, preferably in the range of 0.01 to 2 wt. %, preferably in the range from 0.1 to 1% by weight, based on the composition,
• (d) optionally ectoine and / or at least one ectoine derivative, in particular hydroxyectoine, in an amount in the range from 0.0001 to 10% by weight, in particular in the range from 0.001 to 9% by weight, preferably in the range from 0.01 up to 8% by weight, preferably in the range from 0.1 to 6.5% by weight, particularly preferably in the range from 1.5 to 3% by weight, based on the composition,

having.

As far as the preparation of the composition according to the invention is concerned, this can be carried out by conventional methods familiar to the person skilled in the art. The production takes place in particular by mixing or homogenizing the individual active ingredients or ingredients, followed by the subsequent processing into the desired application form for topical application (eg as ointment, cream, gel, etc.). This is familiar to the skilled person as such, so that no further relevant embodiments are required.

Furthermore, it is particularly advantageous if the composition is present ready for dispensing in containers, in particular with volume sizes in the range of 1 to 1000 ml, in particular in the range of 2 to 500 ml, preferably in the range of 2 to 100 ml, preferably in the range of 3 to 50 ml, more preferably in the range of 4 to 30 ml, most preferably in the range of 5 to 20 ml. In particular, it may be provided in this context that the volume size corresponds to an application amount and / or an application unit.

According to the invention, it is possible in particular to use the composition as described above in the field of pharmacy, medicine or cosmetics.

In this context, it may be provided in particular the composition in the prophylactic and / or therapeutic treatment of the urethra, in particular for the topical treatment of the urethra in surgical and / or transurethral procedures and / or in particular for the prevention and / or reduction of scarring in the urethra , to use.

Yet another object of the present invention - according to a second aspect of the invention - is a container which contains a composition according to the invention, as described above, wherein the container in particular in the form of a tube, bottle, can, a pump and / or dosing dispenser, a syringe or the like, preferably in the form of a syringe.

For further details of this aspect of the invention may be made to avoid unnecessary repetition of the above statements to the first aspect of the invention, which apply accordingly in relation to this aspect of the invention.

Finally, the present invention - according to a third aspect of the invention - the use of a composition according to the invention, as described above, in the field of pharmacy, medicine or cosmetics.

In this context, it can be provided in particular, the inventive composition for prophylactic and / or therapeutic treatment of the urethra, especially for topical treatment of the urethra in surgical and / or transurethral surgery and / or in particular for the prevention and / or reduction of scarring in the urethra , to use.

Moreover, it is equally possible to use the composition according to the invention as described above for the manufacture of a medicament or therapeutic for the prophylactic and / or therapeutic treatment of the urethra, in particular for the topical treatment of the urethra during operative and / or transurethral procedures and / or in particular to avoid and / or reduce scarring in the urethra.

For further details of this aspect of the invention, reference may be made to the above remarks on the other aspects of the invention in order to avoid unnecessary repetition, which apply correspondingly in relation to this aspect of the invention.

Further embodiments, modifications and variations as well as advantages of the present invention will be readily apparent to and realizable by those skilled in the art upon reading the description without departing from the scope of the present invention.

The present invention will be illustrated by the following embodiments, which by no means limit the present invention.

EXAMPLES

In the context of exemplary embodiments or efficacy studies carried out by the Applicant, the outstanding effect of compositions according to the present invention with respect to the prevention or reduction of scar formation due to surgical or transurethral interventions has been demonstrated.

For this purpose, three compositions according to the invention (compare the following Composition A, Composition B and Composition C) were compared with comparison compositions which contained non-inventive active ingredient combinations (see the following Composition D and Composition E) with respect to their effectiveness.

In this context, in particular, the synergistic effect of the combination according to the invention could be shown.

The compositions in detail:

All of the compositions described below had the same aqueous-alcoholic gel base base formulation with the hydroxymethylcellulose gelling agent in a relative amount of 2% by weight, based on the total composition (10 ml), and thus differed only in the presence or absence of individual active ingredients ,

Composition A (according to the invention):

Composition A according to the invention contained the following active ingredient components in the amounts mentioned below, relative amounts being based on the total composition (10 ml):
30 mg onion extract
2% by weight of dexpanthenol

The remaining ingredients (to 100 wt .-%) were based on a gel base, wherein the gel was aqueous-alcoholic based and moreover as gelling agent hydroxymethylcellulose in a relative amount of 2 wt .-%, based on the total composition had.

Composition, B (according to the invention):

Composition B according to the invention contained the following active ingredient components in the amounts mentioned below, relative amounts being based on the total composition (10 ml):
30 mg onion extract
2% by weight of dexpanthenol
50 mg fusafungin

The remaining ingredients (at 100% by weight) were gel-based based on the gel aqueous-alcoholic and, moreover, as gelling agent, hydroxymethylcellulose in a relative amount of 2% by weight, based on the total composition.

Composition C (according to the invention):

Composition C according to the invention contained the following active ingredient components in the amounts mentioned below, relative amounts being based on the total composition (10 ml):
30 mg onion extract
2% by weight of dexpanthenol
50 mg fusafungin
2% by weight of ectoine

The remaining ingredients (to 100 wt .-%) were based on a gel base, wherein the gel was aqueous-alcoholic based and moreover as gelling agent hydroxymethylcellulose in a relative amount of 2 wt .-%, based on the total composition had.

Composition D (comparison):

The non-inventive composition D contained as the sole active ingredient the following active ingredient in the amount mentioned below (based on 10 ml of total composition):
30 mg onion extract

The remaining ingredients (to 100 wt .-%) were based on a gel base, wherein the gel was aqueous-alcoholic based and moreover as gelling agent hydroxymethylcellulose in a relative amount of 2 wt .-%, based on the total composition had.

Composition E (comparison):

The non-inventive composition E contained as the sole active ingredient the following active ingredient in the amount mentioned below (based on 10 ml of total composition):
2% by weight of dexpanthenol

The remaining ingredients (to 100 wt .-%) were based on a gel base, wherein the gel was aqueous-alcoholic based and moreover as gelling agent hydroxymethylcellulose in a relative amount of 2 wt .-%, based on the total composition had.

Efficacy studies:

In order to investigate the efficacy of the compositions of the invention with the efficacy of the comparative compositions, a series of studies was conducted with a panel of 75 patients.

The panel included 75 patients aged 62-84 years, of whom 48 were male and 27 female who needed regular catheterization due to urinary bladder dysfunction for complete emptying of the bladder. To compare the efficacy of the compositions provided, subjects each received one of the compositions as part of each catheterization catheterization gel, with 15 subjects each treated with one of compositions A, B, C, D and E, respectively. The treatment with the respective composition took place over a period of two months.

• • Verhinderung von Harnröhrenvernarbungen bzw. -strikturen
• • Regeneration des Gewebes nach der Katheterisierung
• • Verhinderung bzw. Reduzierung von Infektionen bzw. Entzündungen infolge der häufigen Katheterisierungen.

Subsequent to this treatment period, the evaluation of the effectiveness of the respective composition was carried out with regard to

• • Prevention of urethral scarring or strictures
• Regeneration of the tissue after catheterization
• • Prevention or reduction of infections or inflammation as a result of frequent catheterizations.

The results are shown in the following table.

The evaluation of the respective composition took place according to the school grading system with grades from 1 = very good to 6 = insufficient. Table: Evaluation of compositions according to the school grading system composition A B C D e Avoiding scarring 2.0 1.9 1.7 3.9 4.4 Regeneration of tissue damaged by catheterization 1.9 1.9 1.8 3.5 3.2 Avoidance of inflammation or infection 2.3 1.7 1.5 3.9 4.2

The above results show the excellent effect of the compositions of the invention over the comparative compositions. Excellent results were obtained with compositions A, B and C according to the invention, with the best overall results being obtained with composition C, which had a combination of onion extract, dexpanthenol, fusafungin and ectoin.

In particular, it is clear from the results that the active ingredients complement each other in a synergistic mode of action, since the effect of onion extract on the one hand and panthenol on the other hand when used in combination significantly exceeds the effect of the respective monopreparations. This becomes particularly clear from the results or the assessments of the composition A according to the invention with the comparison compositions D and E not according to the invention, which contained the active ingredients onion extract and dexpanthenol in each case as monohydrogen. With the composition A according to the invention, which contained the combination of onion extract and panthenol according to the invention, excellent results with respect to avoiding scar formation, rapid regeneration of the urothelium and the prevention of inflammations and infections were achieved. On the other hand, the comparisons D and E were unsatisfactory.

In addition, the effect of the composition according to the invention can be further enhanced by using fusafungin and ectoine as additional components. In particular, the reduction of inflammation or infection can be further improved by the additional use of fusafungin, as the results of composition B show. The additional use of ectoine leads to an even faster regeneration of urethral tissue, in particular of the urothelium, which was damaged or damaged as a result of the catheterization, which is evident from the results obtained with composition C.

Summary:

Overall, it can be stated that within the scope of the present invention, a composition could be provided for the first time which enables a well-handled measure for the topical treatment of the urethra in surgical or transurethral interventions and is particularly suitable for preventing or reducing scarring. So far, it has generally been necessary to counteract scarring, especially urethral strictures or urethral strictures, with surgical or surgical therapy measures to allow the patient to complete micturition again.

Furthermore, the composition of the invention also causes a faster regeneration of the tissue as well as an avoidance of infections, as they often occur in the context of transurethral surgery. Such a composition is not known from the prior art.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• EP 0887418 B1 [0056]

Cited non-patent literature

• Römpp Chemielexikon, 10th Edition, 1999, Georg Thieme Verlag, Stuttgart / New York, Keywords "Panthenol" and "Dexpanthenol", pages 927 and 3107-3108 [0029]
• Römpp Chemielexikon, 10th Edition, 1999, Georg Thieme Verlag, Stuttgart / New York, keyword "Fusafungin", page 1442 [0049]

Claims (16)

Composition, in particular pharmaceutical composition, in particular for the prevention and / or reduction of scarring, preferably for the topical treatment of the urethra during surgical and / or transurethral procedures, wherein the composition - in each case effective, especially pharmaceutically effective amounts - as active ingredients, in particular in combination . (a) Onion extract (extract Bulbus cepae) ("component (a)") and (b) panthenol and / or its derivatives, in particular esters, and / or pantothenic acid and / or their physiologically acceptable salts ("component (b)") includes. Composition according to claim 1, wherein the composition comprises (a) onion extract (extract Bulbus cepae) in an amount in the range of 0.0001 to 5 wt .-%, in particular in the range of 0.001 to 2.5 wt .-%, preferably in the range of 0.01 to 2 wt .-%, preferably in the range of 0.05 to 1 wt .-%, based on the composition contains; and or wherein the composition comprises (a) onion extract (cephalic extract) in an absolute amount in the range of 0.1 to 1000 mg, in particular in the range of 1 to 500 mg, preferably in the range of 2 to 250 mg, preferably in the range of 3 to 100 mg, more preferably in the range of 5 to 80 mg, even more preferably in the range of 10 to 50 mg, in particular based on an application unit and / or in particular on an application amount contains; and or wherein the composition (b) panthenol and / or its derivative (s), in particular esters, and / or pantothenic acid and / or their physiologically acceptable salts in an amount in the range of 0.0001 to 10 wt .-%, in particular in the range 0.001 to 9 wt .-%, preferably in the range of 0.01 to 8 wt .-%, preferably in the range of 0.1 to 6.5 wt .-%, particularly preferably in the range of 1 to 5 wt .-% , most preferably in the range of 1.5 to 3 wt .-%, based on the composition contains; and or wherein component (b) is dexpanthenol; and or wherein the composition comprises component (a) and component (b) in a weight ratio of [(a) :( b)] in the range of 1: 1 to 100: 1, in particular in the range of 1.2: 1 to 80 : 1, preferably in the range from 2: 1 to 60: 1, preferably in the range from 3: 1 to 30: 1, particularly preferably in the range from 4: 1 to 20: 1, very particularly preferably in the range from 5: 1 to 15: 1, contains. A composition according to claim 1 or 2, wherein the composition contains as further component (c) fusafungin and / or a fusafungin derivative ("component (c)"); in particular wherein the composition (c) fusafungin and / or at least one fusafungin derivative in an amount in the range of 0.0001 to 5 wt .-%, in particular in the range of 0.001 to 3 wt .-%, preferably in the range of 0.01 to 2 wt .-%, preferably in the range of 0.1 to 1 wt .-%, based on the composition contains; and or in particular wherein the composition (c) fusafungin and / or at least one fusafungin derivative in an absolute amount in the range of 0.1 to 1000 mg, in particular in the range of 1 to 500 mg, preferably in the range of 5 to 250 mg, preferably in the range of 10 to 100 mg, more preferably in the range of 20 to 80 mg, most preferably in the range of 30 to 70 mg, in particular based on an application unit and / or in particular on an application amount contains; and or in particular wherein the composition comprises component (a) and component (c) in a weight-related ratio of [(a) :( c)] in the range from 1:10 to 10: 1, in particular in the range from 1: 5 to 5: 1, preferably in the range from 1: 4 to 4: 1, preferably in the range from 1: 3 to 3: 1, particularly preferably in the range from 1: 2 to 2: 1. A composition according to any one of the preceding claims, wherein the composition contains as further component (d) ectoine and / or at least one ectoine derivative ("component (d)"); in particular where the composition (d) comprises ectoine and / or at least one ectoine derivative in an amount in the range from 0.0001 to 10% by weight, in particular in the range from 0.001 to 9% by weight, preferably in the range from 0.01 to 8 wt .-%, preferably in the range of 0.1 to 6.5 wt .-%, particularly preferably in the range of 1.5 to 3 wt .-%, based on the composition contains; and or in particular wherein component (d) is hydroxyectoine. Composition according to one of the preceding claims, wherein the composition has a viscous and / or pasty consistency and / or wherein the composition is present as an ointment, cream, paste, gel or the like, in particular as a gel; and / or wherein the composition has a Brookfield viscosity at a temperature of 25 ° C in the range of 500 to 100,000 mPas, in particular in the range of 750 to 50,000 mPas, preferably in the range of 1,000 to 10,000 mPas, more preferably in the range of 1,500 to 8,000 mPas, most preferably in the range of 2,000 to 6,000 mPas; and / or wherein the composition has a physiologically acceptable pH and / or a pH in the range of 3 to 8, in particular in the range of 4 to 7.5, preferably in the range of 5 to 7, particularly preferably in the range of 6 to 7; and / or wherein the composition has an electrical conductivity in the physiological range and / or an electrical conductivity in the range of 1 to 20 mS / cm, in particular in the range of 2 to 15 mS / cm, preferably in the range of 5 to 15 mS / cm, having. A composition according to any one of the preceding claims wherein the composition is aqueous or aqueous-alcoholic based and / or wherein the composition contains at least one preferably polyhydric alcohol; in particular wherein the preferably polyhydric alcohol is selected from the group of polyvinyl alcohols, glycerol, glycols and (poly) alkylene glycols and combinations and mixtures thereof, preferably alkylene or polyalkylene glycols, more preferably (poly) propylene glycol, and / or wherein the preferably polyhydric Alcohol is propylene glycol; and or in particular wherein the composition contains the preferably polyhydric alcohol in an amount in the range from 10 to 80% by weight, in particular in the range from 15 to 70% by weight, preferably in the range from 20 to 60% by weight, based on the composition , Composition according to one of the preceding claims, wherein the composition contains water, in particular in an amount of at least 10 wt .-%, in particular at least 20 wt .-%, preferably at least 30 wt .-%, based on the composition, and / or in particular in an amount in the range of 10 to 90 wt .-%, in particular in the range 20 to 85 wt .-%, preferably 30 to 80 wt .-%, based on the composition. A composition according to any one of the preceding claims, wherein the composition contains at least one gelling agent; in particular wherein the gelling agent is selected from the group of bentonites, silicic acids, polyacrylic acids, carbomers, polyvinylpyrrolidones, cellulose and cellulose derivatives, xanthanes and mixtures thereof, preferably cellulose and cellulose derivatives, in particular wherein the gelling agent is preferably selected from modified celluloses, in particular chemically modified celluloses, particularly preferably methylcellulose, hydroxymethylcellulose, carboxymethylcellulose and / or hydroxyethylcellulose, very particularly preferably hydroxymethylcellulose; and or in particular wherein the composition comprises the gelling agent in an amount in the range from 0.01 to 20% by weight, in particular in the range from 0.1 to 10% by weight, preferably in the range from 0.5 to 5% by weight, preferably 1 to 3 wt .-%, based on the composition contains. Composition according to one of the preceding claims, wherein the composition contains at least one acid and / or base, in particular for forming a buffer system, and / or wherein the composition contains at least one buffer system and / or wherein the composition preferably has at least one base, in particular wherein the base is selected from the group of Amines, carboxylates, alkali and / or alkaline earth metal hydroxides and mixtures thereof and combinations, in particular alkali metal and alkaline earth metal hydroxides, preferably sodium hydroxide; and or wherein the composition contains at least one further active ingredient and / or ingredient, in particular selected from the group of skin protection agents, antiseptics, local anesthetics, vitamins, trace elements, minerals, micronutrients and combinations thereof; and or the composition additionally comprising at least one customary pharmaceutical adjunct and / or adjuvant, in particular selected from the group of processing aids, stabilizers, emulsifiers, antioxidants, preservatives, humectants, pH adjusters, pH buffer substances, thickeners, antiseptics, dyeing, buffering agents. , Fragrances, fragrances, binders, wetting agents, preservatives and their combinations. Composition, in particular pharmaceutical composition, in particular for the prevention and / or reduction of scarring, preferably for the topical treatment of the urethra in surgical and / or transurethral procedures, wherein the composition - in each case effective, in particular pharmaceutically effective amounts - as active ingredients, in particular in combination . (a) Onion extract (Bulb cepae extract) in an amount in the range of 0.0001 to 5% by weight, in particular in the range of 0.001 to 2.5% by weight, preferably in the range of 0.01 to 2% by weight. -%, preferably in the range of 0.05 to 1 wt .-%, based on the composition, (b) panthenol and / or its derivatives, in particular esters, and / or pantothenic acid and / or their physiologically acceptable salts in an amount in Range from 0.0001 to 10 wt .-%, in particular in the range of 0.001 to 9 wt .-%, preferably in the range of 0.01 to 8 wt .-%, preferably in the range of 0.1 to 6.5 wt .-%, more preferably in the range of 1 to 5 wt .-%, most preferably in the range of 1.5 to 3 wt .-%, based on the composition, (c) optionally fusafungin and / or at least one Fusafunginderivat in an amount in the range of 0.0001 to 5 wt .-%, in particular in the range of 0.001 to 3 wt .-%, preferably in the range of 0.01 to 2 wt .-%, preferably in the range of 0.1 to 1 Wt .-%, bezo conditions on the composition. Composition, in particular pharmaceutical composition, in particular for the prevention and / or reduction of scarring, preferably for the topical treatment of the urethra in surgical and / or transurethral procedures, wherein the composition - in each case effective, in particular pharmaceutically effective amounts - as active ingredients, in particular in combination . (a) Onion extract (Bulb cepae extract) in an amount in the range of 0.0001 to 5% by weight, in particular in the range of 0.001 to 2.5% by weight, preferably in the range of 0.01 to 2% by weight. %, preferably in the range from 0.05 to 1% by weight, based on the composition, (b) panthenol and / or its derivatives, in particular esters, and / or pantothenic acid and / or physiologically acceptable salts thereof in an amount in the range from 0.0001 to 10% by weight, in particular in the range from 0.001 to 9% by weight. %, preferably in the range of 0.01 to 8 wt .-%, preferably in the range of 0.1 to 6.5 wt .-%, particularly preferably in the range of 1 to 5 wt .-%, most preferably in the range from 1.5 to 3% by weight, based on the composition, (c) optionally fusafungin and / or at least one fusafungin derivative in an amount in the range of 0.0001 to 5 wt .-%, in particular in the range of 0.001 to 3 wt .-%, preferably in the range of 0.01 to 2 wt. %, preferably in the range from 0.1 to 1% by weight, based on the composition, (d) optionally ectoine and / or at least one ectoine derivative, in particular hydroxyectoine, in an amount in the range from 0.0001 to 10% by weight, in particular in the range from 0.001 to 9% by weight, preferably in the range from 0.01 up to 8% by weight, preferably in the range from 0.1 to 6.5% by weight, particularly preferably in the range from 1.5 to 3% by weight, based on the composition, having. A composition according to any one of the preceding claims, wherein the composition is present ready to dosed in containers, in particular with volume sizes in the range of 1 to 1000 ml, in particular in the range of 2 to 500 ml, preferably in the range of 2 to 100 ml, preferably in the range of 3 to 50 ml, more preferably in the range of 4 to 30 ml, most preferably in the range of 5 to 20 ml. Composition according to one of the preceding claims for use in the field of pharmacy, medicine or cosmetics and / or for use in the prophylactic and / or therapeutic treatment of the urethra, in particular for the topical treatment of the urethra during operative and / or transurethral procedures and / or in particular Avoidance and / or reduction of scarring in the urethra. Container containing a composition according to one of the preceding claims, in particular in the form of a tube, bottle, can, a pump and / or dosing dispenser, a syringe or the like, preferably in the form of a syringe. Use of a composition according to any one of the preceding claims in the field of pharmacy, medicine or cosmetics. Use of a composition according to any one of the preceding claims for the prophylactic and / or therapeutic treatment of the urethra, in particular for topical Treatment of the urethra in surgical and / or transurethral surgery and / or in particular for the prevention and / or reduction of scarring in the urethra, and / or for the manufacture of a medicament or therapeutic agent for prophylactic and / or therapeutic treatment of the urethra, in particular for the topical treatment of the urethra Urethra during surgical and / or transurethral surgery and / or in particular to prevent and / or reduce scarring in the urethra.