CN102961250B - Multi-component container and external preparation for treating acne - Google Patents

Multi-component container and external preparation for treating acne Download PDF

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Publication number
CN102961250B
CN102961250B CN201210381893.XA CN201210381893A CN102961250B CN 102961250 B CN102961250 B CN 102961250B CN 201210381893 A CN201210381893 A CN 201210381893A CN 102961250 B CN102961250 B CN 102961250B
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propylene glycol
mixing arrangement
external preparation
component
storage compartment
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CN102961250A (en
Inventor
林山
季玉华
何达
王松
何宇新
孙小伟
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CHENGDU SHANXIN PHARMACEUTICAL Co Ltd
Jiangsu Shan Xin Pharmaceutcal Corp Ltd
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CHENGDU SHANXIN PHARMACEUTICAL Co Ltd
Jiangsu Shan Xin Pharmaceutcal Corp Ltd
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Abstract

The invention provides a multi-component container with a mixing device. The invention also provides an external preparation for treating acne on the basis of the multi-component container. The external preparation provided by the invention can effectively prevent the degradation of active ingredients in Acanya compound preparations and can obviously increase the stability of all ingredients; the storage time of the preparation can be prolonged without refrigerating; the storage cost of the product is lowered; and the portability and use comfort level of the product are greatly increased. Meanwhile, the multi-component container provided by the invention can be used for finishing the steps of mixing and extruding drugs in a device, so that the time is saved and the inconformity and waste of the product caused by manual mixing are avoided.

Description

The external preparation of a kind of many components container and Acne treatment
Technical field
The present invention relates to the external preparation of a kind of many components container and Acne treatment.
Background technology
Acne is a kind of common dermatosis, and the multiple adolescence of being born in, is again comedo, acne.The factor that acne occurs is varied, but the most direct factor is pore to be stopped up, after pore stops up, the oils and fats row of hair follicle the inside is not out, because follicular orifice is blocked, hair follicle luminal stenosis, forms anaerobic condition, makes a large amount of hypertrophy of intrafollicular anaerobe, cause microorganism unbalance, human body starts inflammatory mediator, and acne redden, and have just formed acne.
Now have the preparation of multiple Acne treatment, major part is the independent preparation of benzoyl peroxide or itself and some antibiotic compositionss, but use separately benzoyl peroxide to have zest problem, can cause the general red of skin and affect the observation that patient improves initial stage acne.Therefore, due to the problem of stimulus object, benzoyl peroxide treatment is invalid to some patient, and benzoyl peroxide is while being used for the treatment of acne, also can cause the problems such as xerosis cutis, peeling.
Problem due to benzoyl peroxide existence, medicine worker is used in combination Acne treatment by benzoyl peroxide and some drugs, as United States Patent (USP) 4497794, a kind of compositions containing benzoyl peroxide and erythromycin, the commodity Benzamycin by name of said preparation, be widely used for Acne treatment, be considered in some cases more effective than independent use benzoyl peroxide.After this, U.S. Valeant drugmaker produces the gel compound preparation that listing contains clindamycin phosphate and these two kinds of active medicines of benzoyl peroxide, be the anti-acne gel compound preparation of latest generation, commodity are called Acanya, and this product occurs that the probability of untoward reaction is lower than 0.2%.
But inventor studies discovery, in hybrid packed Acanya compound gel, the content of clindamycin phosphate and benzoyl peroxide meeting fast reducing, shows that the stability of this gel exists defect.
Summary of the invention
In order to address the above problem, the object of the present invention is to provide a kind of many components container.Another object of the present invention is to provide a kind of acne external preparation having good stability.
The invention provides a kind of container of many components with mixing arrangement, comprise at least two independent storage compartments, propeller, mixing arrangement, wherein said propeller is arranged in bottom enclosure, described storage compartment is arranged in upper case, the top of described storage compartment is provided with charge door and capping, what described upper case slided is nested in bottom enclosure, the bottom of described storage compartment is pressed on described propeller, described mixing arrangement is arranged on the top of upper case, described mixing arrangement top-side is provided with discharging opening, the charging aperture of described mixing arrangement is communicated with the discharging opening of described storage compartment.
Described mixing arrangement consists of barrel shrond and inner helical duct.
The lateral surface of described container upper case is provided with scale.
Further, described propeller is nested in the top of described mixing arrangement, the discharging opening that is arranged on described angle of rake upper side is communicated with the discharging opening of described mixing arrangement by pipeline, between described propeller and described mixing arrangement, be provided with spring, described spring is stage clip, in storage compartment, set up suction pipe, the upper port of described suction pipe is communicated with the charging aperture of described mixing arrangement, and the lower port of described suction pipe reaches the bottom of described storage compartment.
Further, each storage compartment is measure-alike; The discharging opening of each storage compartment is measure-alike.
The present invention also provides a kind of external preparation of Acne treatment, and the effective ingredient of described external preparation is BP and clindamycin phosphate, and two kinds of effective ingredient are placed in separately respectively in the different storage compartments of above-mentioned many components container.
Wherein, described external preparation is gel.
Further, described gel is that supplementary material by following weight proportion is prepared from:
Component A:
Benzoyl peroxide 5-10 part, aqueous gel substrate 10-20 part, antiseptic 0.1-0.5 part, water 70-85 part; PH adjusting agent regulates pH to 5.0 ~ 7.0;
B component:
Clindamycin phosphate 2-5 part, aqueous gel substrate 10-20 part, antiseptic 0.1-0.5 part, water 75-88 part; PH adjusting agent regulates pH to 5.0 ~ 7.0.
Wherein, described aqueous gel substrate is one or more the combination in glycerol, propylene glycol, carbomer, cellulose derivative, alginate, tragakanta, gelatin;
Described antiseptic is one or more the combination in methyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben, sorbic acid, sodium benzoate;
Described pH adjusting agent is one or more the combination in sodium hydroxide, potassium hydroxide.
Further, described gel is that supplementary material by following percentage by weight is prepared from:
Component A:
Benzoyl peroxide 5-10 part, 1.25 parts of carbomers, 10 parts of propylene glycol, 0.2 part of methyl hydroxybenzoate, 0.05 part of propylparaben, water 78.5-83.5 part; Potassium hydroxide regulates pH to 5.0 ~ 7.0;
B component:
2.4 parts of clindamycin phosphates, 1.25 parts of carbomers, 10 parts of propylene glycol, 0.2 part of methyl hydroxybenzoate, 0.05 part of propylparaben, 86.1 parts, water; Potassium hydroxide regulates pH to 5.0 ~ 7.0.
The present invention also provides the preparation method of above-mentioned external preparation, and it comprises following operating procedure:
(1) by proportioning, take supplementary material;
(2) getting propylene glycol is dissolved in water and is mixed with aqueous solution of propylene glycol; Get 90% of aqueous solution of propylene glycol total amount, add the carbomer of recipe quantity fully to stir swelling, add again the benzoyl peroxide of recipe quantity and methyl hydroxybenzoate, propylparaben, stirring is uniformly dispersed it, potassium hydroxide is adjusted pH to 5.0 ~ 7.0, add residue aqueous solution of propylene glycol to full dose, obtain component A;
(3) getting propylene glycol is dissolved in water and is mixed with aqueous solution of propylene glycol; Get 90% of aqueous solution of propylene glycol total amount, add the clindamycin phosphate of recipe quantity that it is dissolved completely, the carbomer that adds again recipe quantity, stirring makes its abundant swelling, add after methyl hydroxybenzoate, propylparaben, with potassium hydroxide, regulate pH to 5.0 ~ 7.0, add residue aqueous solution of propylene glycol to full dose, obtain B component;
(4) component A and B component are placed in separately respectively in the different storage compartments of above-mentioned many components container to encapsulation.
In the present invention's prescription, the viscosity of component A, B is suitable, and multiple component containers Zhong Ge storage compartment size and each discharging opening are measure-alike in addition, has guaranteed that two of patient's use become divided doses consistent.
Gel provided by the invention, can effectively avoid the degraded of effective ingredient in Acanya compound preparation, significantly improve each ingredient stability, without cold preservation, can extend the preparation resting period, reduce the cost of storage of product, greatly increased portability and the comfort of product; Meanwhile, multiple component containers provided by the invention, can make medicament mixed extrusion step complete in device inside, has not only saved the time, and the product of avoiding artificial mixing to cause is inconsistent and waste.
Accompanying drawing explanation
The propeller of Fig. 1 multiple component containers of the present invention is located at polycrystalline substance schematic diagram;
The propeller of Fig. 2 multiple component containers of the present invention is located at superstructure schematic diagram;
The propeller of Fig. 3 multiple component containers of the present invention melt with mixing arrangement in structural representation;
In figure: 1-bottom enclosure, 2-upper case, the B of 3-storage compartment, 4-helical duct, 5-mixing arrangement,
6-charge door and capping, the A of 7-storage compartment, 8-propeller, 9-spring, the B of 10-storage compartment suction pipe, the A of 11-storage compartment suction pipe.
The specific embodiment
Many components container of embodiment 1 band mixing arrangement of the present invention
Below in conjunction with accompanying drawing, the present invention is described in further detail.
As Fig. 1, a kind of container of many components with mixing arrangement provided by the invention, comprise at least two independent storage compartments 3, 7, propeller 8, mixing arrangement 5, wherein said propeller 8 is arranged in bottom enclosure 1, described storage compartment 3, 7 are arranged in upper case 2, described storage compartment 3, 7 top is provided with charge door and capping 6, what described upper case 2 slided is nested in bottom enclosure 1, described storage compartment 3, 7 bottom is upward sliding under the effect of described propeller 8, described mixing arrangement 5 is arranged on the top of upper case 1, described mixing arrangement 5 top-side are provided with discharging opening, the charging aperture of described mixing arrangement 5 and described storage compartment 3, 7 discharging opening is communicated with.Different component substance is contained in different storage compartments, presses in use mixing arrangement 5 downwards.Certainly those skilled in the art also can, bottom propeller 8 by simple distortion, be moved to tip position, as shown in Figure 2.
Preferably, described mixing arrangement 5 mainly consists of barrel shrond and inner helical duct 4.Helical duct has extended the incorporation time of component, makes the more even, abundant of component mixing.
Preferably, the lateral surface of described container upper case 2 is provided with scale.Can control more accurately each consumption, improve the utilization rate of component.
Further, as Fig. 3, described propeller 8 is nested in the top of described mixing arrangement 5, and the discharging opening of the upper side of described propeller 8 is communicated with the discharging opening of described mixing arrangement 5 by pipeline, between described propeller 8 and described mixing arrangement 5, be provided with spring 9, described spring 9 is stage clips.Press in use propeller 8 downwards, the component mixing in mixing arrangement 5 is just discharged from the discharging opening of the upper side of propeller 8, unclamp after propeller 8, under the effect of spring 9, propeller 8 is resetted, and simultaneously different component A, B entered into again in mixing arrangement 5 and is mixed into and uses ready next time by the A of storage compartment suction pipe 11, the B of storage compartment suction pipe 10 respectively.This malformation, has reduced the overall volume of container, is convenient to store and transportation.
When the present invention uses, first open the capping of the charge door of storage compartment, the component that fill is different, fill completes, and builds capping.Now container, by interactional material by physically-isolated method, intercepts its reaction each other; Again by the top of squeeze receptacle, make to discharge after component mixing before use, can make to mix extrusion step and complete in device inside, save time, and the product of avoiding artificial mixing to cause is inconsistent and waste; And product with existing mixed, can reach the object that improves its each autostability, extends the shelf life for existing.
Further, each storage compartment is measure-alike, and this has also guaranteed that the material volume squeezing out from different storage compartments is also identical.
Further, the discharging opening size of each storage compartment is all identical, and this is identical with regard to the suffered pressure of the material that can guarantee to be squeezed out, and guarantees the uniformity of mixing.
In the compound preparation being formed by multi-medicament, the problem such as having greatly can be because the wherein interaction of composition and cause product can not stablize in a long time, and the shelf-life is short.For solving problems, conventional way is in product, to add various additives, brings so again new problem, the production cost of product is improved, the serious performance that may affect product, the side effect that particularly may cause.For fear of problems, the preparation that many components form, adopts a plurality of packings separately conventionally, mix again before use, although can extend like this shelf-life of product, inconvenient to use.The present invention is simple and reliable for structure, adopt the container of this structure, by physically-isolated method, for two or more components are just mixed before use, easy to operate, can effectively reduce reacting to each other between medicine, reach product and keep in a long time stable, use no or little additive, improved the quality of product, reduced production cost, used easy to operate simultaneously.
The preparation of the gel of embodiment 2 Acne treatments of the present invention
Prescription:
Component Component A weight (g) B component weight (g)
Benzoyl peroxide 5.0 0
Clindamycin phosphate 0 2.4
Carbomer 1.25 1.25
Propylene glycol 10.0 10.0
Methyl hydroxybenzoate 0.2 0.2
Propylparaben 0.05 0.05
Water 83.5 86.1
Potassium hydroxide regulates pH pH=5.0 pH=5.0
Preparation method:
(1) by proportioning, take supplementary material;
(2) getting propylene glycol is dissolved in water and is mixed with aqueous solution of propylene glycol; Get 90% of aqueous solution of propylene glycol total amount, add the carbomer of recipe quantity fully to stir swelling, then add the benzoyl peroxide of recipe quantity and methyl hydroxybenzoate, propylparaben, stirring is uniformly dispersed it, potassium hydroxide is adjusted pH to 5.0, adds residue aqueous solution of propylene glycol to full dose, obtains component A;
(3) getting propylene glycol is dissolved in water and is mixed with aqueous solution of propylene glycol; Get 90% of aqueous solution of propylene glycol total amount, add the clindamycin phosphate of recipe quantity that it is dissolved completely, the carbomer that adds again recipe quantity, stirring makes its abundant swelling, add after methyl hydroxybenzoate, propylparaben, with potassium hydroxide, regulate pH to 5.0, add residue aqueous solution of propylene glycol to full dose, obtain B component;
(4) component A and B component are placed in separately respectively in the different storage compartments of many components container described in embodiment 1 to encapsulation.
The preparation of embodiment 3 Acne treatment gel of the present invention
Prescription:
Component Gel A weight (g) Gel B weight (g)
Benzoyl peroxide 10.0 0
Clindamycin phosphate 0 2.4
Carbomer 1.25 1.25
Propylene glycol 10.0 10.0
Methyl hydroxybenzoate 0.2 0.2
Propylparaben 0.05 0.05
Water 78.5 86.1
Potassium hydroxide regulates pH pH=5.0 pH=5.0
Preparation method:
(1) by proportioning, take supplementary material;
(2) getting propylene glycol is dissolved in water and is mixed with aqueous solution of propylene glycol; Get 90% of aqueous solution of propylene glycol total amount, add the carbomer of recipe quantity fully to stir swelling, then add the benzoyl peroxide of recipe quantity and methyl hydroxybenzoate, propylparaben, stirring is uniformly dispersed it, potassium hydroxide is adjusted pH to 7.0, adds residue aqueous solution of propylene glycol to full dose, obtains component A;
(3) getting propylene glycol is dissolved in water and is mixed with aqueous solution of propylene glycol; Get 90% of aqueous solution of propylene glycol total amount, add the clindamycin phosphate of recipe quantity that it is dissolved completely, the carbomer that adds again recipe quantity, stirring makes its abundant swelling, add after methyl hydroxybenzoate, propylparaben, with potassium hydroxide, regulate pH to 7.0, add residue aqueous solution of propylene glycol to full dose, obtain B component;
(4) component A and B component are placed in separately respectively in the different storage compartments of many components container described in embodiment 1 to encapsulation.
In the prescription of the embodiment of the present invention 2,3, the viscosity of component A, B is suitable, and multiple component containers Zhong Ge storage compartment size and each discharging opening are measure-alike in addition, has guaranteed that two of patient's use become divided doses consistent.By test example, illustrate beneficial effect of the present invention below.
The stability contrast experiment of test example 1 gel of the present invention and existing product
(1) medicine:
Of the present invention group: the gel that active component is separately packed of embodiment 2,3 preparations;
Matched group: press the formula preparation gel of embodiment 2, after component A, B are mixed, packing;
Acanya group: i.e. Acanya product.
(2) experimental technique
Get of the present invention group, matched group, Acanya group, be together placed under 40 ℃, RH75% condition and carry out accelerated stability investigation, and synchronously increase the parallel investigation of reference preparation.Two gel components that wherein the present invention separately packs sample after each sample point mixes with 1:1, carry out each main constituent content detection, and it is as follows that each product stability is investigated result:
Table 1
Note: BPO---benzoyl peroxide; CP---clindamycin phosphate
From the above results, at accelerated stability, investigate in experiment, in the gel of the embodiment of the present invention 2,3 preparations, benzoyl peroxide, clindamycin phosphate content are significantly higher than matched group (hybrid packed) and Acanya product.
Experiment shows, gel of the present invention can effectively be avoided the degraded of effective ingredient in Acanya compound preparation, significantly improves each ingredient stability, without cold preservation, can extend the preparation resting period, reduce the cost of storage of product, greatly increased portability and the comfort of product.
The study on the stability of the gel of each device preparation of test example 2 the present invention
Get three devices of Fig. 1-3, by the method for embodiment 2, prepare gel, light pressure device top obtains mixing rear product, and each device is chosen three duplicate samples, compares its outward appearance and medicament contg thereof, and result is as follows:
Table 2
Note: BPO---benzoyl peroxide; CP---clindamycin phosphate
From the above results, the gel that the various devices of the present invention prepare, extrudes medicament appearance and medicament contg homogeneous, without obviously difference between batch is other, shows that various device effect provided by the invention is suitable.
In sum, external preparation provided by the invention, can effectively avoid the degraded of effective ingredient in Acanya compound preparation, significantly improve each ingredient stability, without cold preservation, can extend the preparation resting period, reduce the cost of storage of product, greatly increased portability and the comfort of product; Meanwhile, multiple component containers provided by the invention, can make medicament mixed extrusion step complete in device inside, has not only saved the time, and the product of avoiding artificial mixing to cause is inconsistent and waste.

Claims (8)

1. an external preparation for Acne treatment, is characterized in that: the effective ingredient of described external preparation is benzoyl peroxide and clindamycin phosphate, and two kinds of effective ingredient are placed in separately respectively in the different storage compartments with many components container of mixing arrangement;
The described container of many components with mixing arrangement, comprise at least two independent storage compartments (3, 7), propeller (8), mixing arrangement (5), it is characterized in that: propeller (8) is arranged in bottom enclosure (1), storage compartment (3, 7) be arranged in upper case (2), storage compartment (3, 7) top is provided with charge door and capping (6), what upper case (2) slided is nested in bottom enclosure (1), storage compartment (3, 7) bottom is pressed on propeller (8), mixing arrangement (5) is arranged on the top of upper case (2), mixing arrangement (5) top-side is provided with discharging opening, the charging aperture of mixing arrangement (5) and storage compartment (3, 7) discharging opening is communicated with,
Described external preparation is gel, and described gel is that the supplementary material by following weight proportion is prepared from:
Component A:
Benzoyl peroxide 5-10 part, aqueous gel substrate 10-20 part, antiseptic 0.1-0.5 part, water 70-85 part; PH adjusting agent regulates pH to 5.0 ~ 7.0;
B component:
Clindamycin phosphate 2-5 part, aqueous gel substrate 10-20 part, antiseptic 0.1-0.5 part, water 75-88 part; PH adjusting agent regulates pH to 5.0 ~ 7.0.
2. external preparation according to claim 1, is characterized in that: described aqueous gel substrate is one or more the combination in glycerol, propylene glycol, carbomer, cellulose derivative, alginate, tragakanta, gelatin;
Described antiseptic is one or more the combination in methyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben, sorbic acid, sodium benzoate;
Described pH adjusting agent is one or more the combination in sodium hydroxide, potassium hydroxide.
3. external preparation according to claim 1 and 2, is characterized in that: described gel is that the supplementary material by following percentage by weight is prepared from:
Component A:
Benzoyl peroxide 5-10 part, 1.25 parts of carbomers, 10 parts of propylene glycol, 0.2 part of methyl hydroxybenzoate, 0.05 part of propylparaben, water 78.5-83.5 part; Potassium hydroxide regulates pH to 5.0 ~ 7.0;
B component:
2.4 parts of clindamycin phosphates, 1.25 parts of carbomers, 10 parts of propylene glycol, 0.2 part of methyl hydroxybenzoate, 0.05 part of propylparaben, 86.1 parts, water; Potassium hydroxide regulates pH to 5.0 ~ 7.0.
4. external preparation according to claim 1, is characterized in that: described mixing arrangement (5) consists of barrel shrond and inner helical duct (4).
5. external preparation according to claim 1, is characterized in that: the lateral surface of described upper case (2) is provided with scale.
6. external preparation according to claim 1, it is characterized in that: described propeller (8) is nested in the top of mixing arrangement (5), the discharging opening that is arranged on the upper side of propeller (8) is communicated with the discharging opening of mixing arrangement (5) by pipeline, between propeller (8) and mixing arrangement (5), be provided with spring (9), spring (9) is stage clip, storage compartment (3,7) in, set up suction pipe (10,11), the upper port of suction pipe (10,11) is communicated with the charging aperture of mixing arrangement (5), suction pipe (10,11) lower port reaches the bottom of storage compartment (3,7).
7. external preparation according to claim 1, is characterized in that: each storage compartment is measure-alike; The discharging opening of each storage compartment is measure-alike.
8. the preparation method of external preparation described in claim 1, is characterized in that: it comprises following operating procedure:
(1) by proportioning, take supplementary material;
(2) getting propylene glycol is dissolved in water and is mixed with aqueous solution of propylene glycol; Get 90% of aqueous solution of propylene glycol total amount, add the carbomer of recipe quantity fully to stir swelling, add again the benzoyl peroxide of recipe quantity and methyl hydroxybenzoate, propylparaben, stirring is uniformly dispersed it, potassium hydroxide is adjusted pH to 5.0 ~ 7.0, add residue aqueous solution of propylene glycol to full dose, obtain component A;
(3) getting propylene glycol is dissolved in water and is mixed with aqueous solution of propylene glycol; Get 90% of aqueous solution of propylene glycol total amount, add the clindamycin phosphate of recipe quantity that it is dissolved completely, the carbomer that adds again recipe quantity, stirring makes its abundant swelling, add after methyl hydroxybenzoate, propylparaben, with potassium hydroxide, regulate pH to 5.0 ~ 7.0, add residue aqueous solution of propylene glycol to full dose, obtain B component;
(4) component A and B component are placed in separately respectively in the different storage compartments of many components container to encapsulation.
CN201210381893.XA 2012-10-10 2012-10-10 Multi-component container and external preparation for treating acne Active CN102961250B (en)

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Publication number Priority date Publication date Assignee Title
CN106729722B (en) * 2016-11-21 2020-05-12 成都山信药业有限公司 Method for preparing stable compound preparation and compound preparation
CN107737135A (en) * 2017-11-28 2018-02-27 江苏万川医疗健康产业集团有限公司 A kind of pharmaceutical preparation and preparation method and application

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US4056611A (en) * 1973-04-16 1977-11-01 Stiefel Laboratories, Inc. Therapeutic composition
US4318907A (en) * 1978-04-04 1982-03-09 Westwood Pharmaceuticals, Inc. Method for treating acne vulgaris and compositions useful for that purpose
CN1077887A (en) * 1992-02-18 1993-11-03 劳埃德·J·巴鲁迪 The compositions that contains benzoyl peroxide and clindamycin that is used for the treatment of acne
CN1764437A (en) * 2003-01-23 2006-04-26 埃德科贸易和代理有限公司 Topical pharmaceutical and/or cosmetic dispense systems
CN102235572A (en) * 2010-05-04 2011-11-09 贺利氏医疗有限公司 Cartridge system with compressed gas cartridge

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4056611A (en) * 1973-04-16 1977-11-01 Stiefel Laboratories, Inc. Therapeutic composition
US4318907A (en) * 1978-04-04 1982-03-09 Westwood Pharmaceuticals, Inc. Method for treating acne vulgaris and compositions useful for that purpose
CN1077887A (en) * 1992-02-18 1993-11-03 劳埃德·J·巴鲁迪 The compositions that contains benzoyl peroxide and clindamycin that is used for the treatment of acne
CN1764437A (en) * 2003-01-23 2006-04-26 埃德科贸易和代理有限公司 Topical pharmaceutical and/or cosmetic dispense systems
CN102235572A (en) * 2010-05-04 2011-11-09 贺利氏医疗有限公司 Cartridge system with compressed gas cartridge

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