CN102258521A - Cefodizime sodium composition and preparation method thereof - Google Patents
Cefodizime sodium composition and preparation method thereof Download PDFInfo
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- CN102258521A CN102258521A CN2011101494560A CN201110149456A CN102258521A CN 102258521 A CN102258521 A CN 102258521A CN 2011101494560 A CN2011101494560 A CN 2011101494560A CN 201110149456 A CN201110149456 A CN 201110149456A CN 102258521 A CN102258521 A CN 102258521A
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Abstract
The invention relates to the fields of pharmaceutical compositions and preparations thereof, and relates to a preparation method of an antibacterial medicament, in particular to a stable cefodizime sodium composition preparation and a preparation method thereof. In the invention, the sterile cefodizime sodium is directly dissolved in water; sterile potassium clavulanate is added and fully dissolved to obtain aqueous solution of cefodizime sodium/potassium clavulanate; hydroxypropyl-beta-cyclodextrin (HP-beta-CD) is added into the aqueous solution for inclusion; and subpackaging and freeze-drying are performed to obtain the cefodizime sodium/potassium clavulanate for injection. The preparation method provided by the invention is simple; after the cefodizime sodium/potassium clavulanate is included by the hydroxypropyl-beta-cyclodextrin, the stability of a sterile cefodizime sodium medicament is enhanced, the toxic or side effect of the composition is reduced, the utilization rate of the medicament is improved, and the preparation process is simple and is suitable for industrial production.
Description
Technical field
The present invention relates to a kind of antibacterials and preparation method thereof, relate in particular to a kind of stable Cefodizime Sodium composition and method of making the same.
Background technology
Cefodizime Sodium belongs to third generation cephalosporin for injections class antibiotic, and by German Hirst company and the exploitation of Japanese roc company, go on the market in Japan with trade name " Neucef " May nineteen ninety.Your company's cefodizime sodium for injection (not enemy) of German Hirst-Ruse obtained registration in China in 1994.
Cefodizime is for first has the third generation cephalosporin of immune enhancing function in the world, has antimicrobial spectrum widely, the clinical Streptococcus that is mainly used in, pneumonia due to the sensitive organisms such as streptococcus pneumoniae, bronchitis, pharyngolaryngitis, tonsillitis, pyelonephritis, urinary tract infection, gonococcal urethritis, cholecystitis, cholangitis, gynecological infection, septicemia and otitis media etc., but Cefodizime is to coagulating Bacillus, Enterobacter, the epidermis glucose, Bacterium prodigiosum has different sensitivity, to Rhodopseudomonas, acinetobacter, enterococcus faecalis, monocytogenes Li Site Salmonella, mycoplasma and chlamydia etc. are insensitive.
The preparation of Cefodizime Sodium in the market mainly is the cefodizime sodium for injection aseptic powder injection, said preparation exists poor stability, and is very unstable to light and heat, and being placed with related substance for a long time increases, and turbid phenomenon occurs after the dissolving, cause it to run into a lot of difficulties in the use.
For solving its antimicrobial spectrum to coagulating Bacillus, Enterobacter, epidermis glucose, Bacterium prodigiosum, Rhodopseudomonas, acinetobacter, enterococcus faecalis, monocytogenes Li Site Salmonella, mycoplasma and the insensitive weak point of chlamydia, Chinese patent file CN101810621.A mixes Cefodizime Sodium and obtains compositions with sulbactam, but said composition is just mixed Cefodizime Sodium simply with sulbactam, be difficult to obtain the uniform composite preparation of content.
For solving its stability problem, Chinese patent file 200910016147.9 discloses lipidosome freeze-dried preparation of a kind of Cefodizime and preparation method thereof, but its preparation process more complicated, and the preparation yield of liposome is very low, is not suitable for suitability for industrialized production.
Existing in the market cefodizime sodium for injection mainly is the powder injection formulation of Cefodizime Sodium dilution crystallization aseptic powder, in the preparation production process, exist simultaneously and be difficult to the packing problem, present in addition Cefodizime Sodium stability of formulation is relatively poor, being placed with related substance for a long time increases a lot, the prescription in the time that can not satisfy the prescriptive period.Urgent need provides the Cefodizime sodium medicament preparation that has good stability and be suitable for clinical use.
Summary of the invention
In order to overcome the deficiency that existing Cefodizime Sodium exists, solve prior art for preparing cefodizime sodium for injection antimicrobial spectrum deficiency, and present cefodizime sodium for injection stability of formulation is relatively poor, being placed with related substance for a long time increases, cause the problems such as prescription in the time that to satisfy the prescriptive period, the invention provides a kind of stable Cefodizime Sodium and the blended composite preparation of clavulanate potassium and preparation method thereof, enlarged the antimicrobial spectrum of Cefodizime Sodium, improved the stability of Cefodizime Sodium, for the use of cefodizime sodium for injection provides reliable technique support more.
The present invention mainly contains two purposes, and the one, solve the antibiotic weak point of Cefodizime, the one, solve the preparation stability problem; Adopt with the clavulanate potassium combination and solve antibiotic deficiency; Adopt cyclodextrin inclusion compound to solve stability, comprehensive above-mentioned 2 requirements, the technical solution adopted in the present invention is as follows:
This pharmaceutical composition only contains Cefodizime Sodium, clavulanate potassium and HP-(HP-β-CD); Described preparation is an ejection preparation, and wherein the ejection preparation among the present invention comprises injection or lyophilized injectable powder; No matter adopt which kind of dosage form, the amount of active component is following ranges in the pharmaceutical composition of the present invention:
The compositions proportioning of specifically selecting for use is counted by weight:
Cefodizime Sodium 1～2
Clavulanate potassium 2～6
(HP-β-CD) 1～4 for HP-
(β-CD) there is the hydroxyl that C2 on the glucose molecule, C3 connect at an end opening place in molecule hole to beta-schardinger dextrin-, other end opening is the hydroxyl that C6 connects, so the two ends of tubular structure are hydrophilic, and its hole have the glucosyl group oxo bridge and-the CH-group, so be hydrophobic in the hole.Some sizeable drug molecules form inclusion complex often by Van der Waals force with its inclusion in hydrophobic region.HP-(HP-β-CD) be beta-schardinger dextrin-(β-CD) in alkaline aqueous solution with the ethylene chlorhydrin condensation polytype CD.HP-tool safe dose is big, good with blood compatibility, do not change characteristics such as drug effect, the water solublity that increases medicine, stability, is considered to more promising drug carrier material.Adopt HP-to coat active component Cefodizime composition of sodium in the pharmaceutical composition of the present invention, make the Cefodizime composition of sodium to be wrapped up, finally prepare the stable Cefodizime sodium medicament preparation that formulation and technology is simplified by its hydrophobic region.
Aforesaid Cefodizime Sodium ejection preparation comprises injection and lyophilized injectable powder, therefore, Cefodizime composition of sodium of the present invention must use water for injection in preparation process, the consumption of water for injection is not particularly limited, and determines corresponding water for injection use amount according to product specification.If lyophilized injectable powder, then the composition of above-mentioned composition is meant that said preparation is the composition content of lyophilized injectable powder, at this moment, because factors such as technologies, it also is understandable existing pharmacy to allow the water of content in the final preparation, then may contain the water of final total formulation weight amount 0～6wt% in the preparation; If said preparation is an injection, then the weight ratio of Cefodizime Sodium and water for injection changes in 1: 5～50 scope, preferred 1: 5～20, more preferably 1: 5-15, further preferred 1: 5～10.If final preparation is a lyophilized injectable powder, the water for injection that uses in preparation process also changes in above-mentioned scope, only needs in the final preparation water for injection content to reach above-mentioned standard and gets final product.
Cefodizime Sodium of the present invention is the product of directly buying on the market or adopting prior art directly to obtain, employing be aseptic Cefodizime Sodium, it has the characteristic identical with Cefodizime Sodium described in the prior art; The clavulanate potassium that is adopted is commercially available aseptic clavulanate potassium, why select aseptic clavulanate potassium for use, mainly be since clavulanate potassium can with the beta-lactamase strong bonded of majority, generate irreversible conjugate, make it have brute force and the effect of broad-spectrum inhibition beta-lactamase, not only staphylococcic enzyme there is effect, and the enzyme that multiple gram-negative bacteria produced also there is effect, be effective β-Nei Xiananmeiyizhiyao, the present invention is with clavulanate potassium and Cefodizime interworking, by adjusting the proportioning of above-mentioned two kinds of materials, can strengthen Cefodizime to some because of producing the antibacterial activity of beta lactamase to it drug-fast gram negative bacilli, the sulbactam of Cai Yonging is compared with the combination of Cefodizime Sodium compared to prior art, have wider antimicrobial spectrum, and cost is lower.
The set of dispense of above-mentioned disclosed pharmaceutical composition than the basis on, the weight portion proportioning that the present inventor further optimizes the Cefodizime sodium medicament compositions is as follows:
Cefodizime Sodium 1～1.5
Clavulanate potassium 2～4
(HP-β-CD) 1～3 for HP-
Further preferably, Cefodizime sodium medicament compositions of the present invention contains the component of following weight proportion:
Cefodizime Sodium 1～1.2
Clavulanate potassium 2～3
(HP-β-CD) 1～2 for HP-
Most preferably, Cefodizime sodium medicament compositions of the present invention contains the component of following weight proportion:
Cefodizime Sodium 1～1.2
Clavulanate potassium 2～2.4
(HP-β-CD) 1～1.8 for HP-
After adopting above-mentioned proportioning, the Cefodizime sodium medicament compositions that is obtained can obtain more excellent effect.
Another object of the present invention provides a kind of Cefodizime sodium medicament preparation of compositions method, this method directly is dissolved in aseptic β-Cefodizime Sodium in the water for injection, add aseptic clavulanate potassium, stirring makes its whole dissolvings, get the aqueous solution of Cefodizime Sodium and clavulanate potassium mixture, (HP-β-CD) carries out enclose to add HP-in this aqueous solution, through packing, promptly get Cefodizime Sodium injecta composition of the present invention, if desired, the injection lyophilization is promptly got cefodizime sodium for injection lyophilized injectable powder compositions.
Concrete preparation method is as follows:
1) the aseptic Cefodizime Sodium of adding prescription amount is dissolved in the water for injection in the room temperature downhill reaction still; The clavulanate potassium that adds the prescription amount afterwards stirs and makes its whole dissolvings, gets the aqueous solution of Cefodizime Sodium and clavulanate potassium;
2) in above-mentioned reactor, add HP-(HP-β-CD), the stirring at room enclose 0.5～2.0 hour of prescription amount; Add injection and be diluted with water to the required content of cefodizime sodium for injection preparation, the filtering with microporous membrane of reuse 0.45 μ m, by the filtering with microporous membrane of 0.22 μ m, packing promptly gets the cefodizime sodium for injection freeze-dried powder through lyophilization at last.
Preferably, described step 2) the stirring at room enclose is 0.5～2.0 hour, most preferred selection 1.0～1.5 hours; Adopt above-mentioned comprise the time after, can stable Cefodizime Sodium and the blended composite preparation of clavulanate potassium of maximized acquisition.
Adopt the Cefodizime Sodium and the blended composite preparation of clavulanate potassium of method for preparing, enlarged the antimicrobial spectrum of Cefodizime Sodium, improved the stability of Cefodizime Sodium, for the use of cefodizime sodium for injection provides reliable technique support more, the preparation method that is adopted is simple, reduced the toxic and side effects of medicine, be fit to more apply widely.
The specific embodiment
The present invention will be further described below in conjunction with embodiment, and described only is several concrete forms of implementation of the present invention, is not limitation of the present invention, to those skilled in the art, can also make many distortion and improvement.All do not exceed the described distortion of claim or improvement all should be considered as scope of the present invention.
Embodiment 1:
The proportioning of compositions is:
Preparation technology:
Adding aseptic Cefodizime Sodium in the room temperature downhill reaction still is dissolved in the water for injection; Add aseptic clavulanate potassium, stir and make its whole dissolvings, get the aqueous solution of Cefodizime Sodium and clavulanate potassium mixture; In reactor, add HP-(HP-β-CD), stirred enclose 1.0 hours; Add injection and be diluted with water to the required content of cefodizime sodium for injection preparation, the filtering with microporous membrane of reuse 0.45 μ m, by the filtering with microporous membrane of 0.22 μ m, packing promptly gets cefodizime sodium for injection/clavulanate potassium freeze-dried powder through lyophilization at last.
Embodiment 2:
Preparation technology:
Adding aseptic Cefodizime Sodium in the room temperature downhill reaction still is dissolved in the water for injection; Add aseptic L-clavulanate potassium, stir and make its whole dissolvings, get the aqueous solution of Cefodizime Sodium and clavulanate potassium mixture; In reactor, add HP-(HP-β-CD), stirred enclose 1.5 hours; The filtering with microporous membrane of reuse 0.45 μ m, by the filtering with microporous membrane of 0.22 μ m, packing obtains the Cefodizime sodium injection at last.
Embodiment 3:
Preparation technology:
Adding aseptic Cefodizime Sodium in the room temperature downhill reaction still is dissolved in the water for injection; Add aseptic clavulanate potassium, stir and make its whole dissolvings, get the aqueous solution of Cefodizime Sodium and clavulanate potassium mixture; In reactor, add HP-(HP-β-CD), stirred enclose 0.5 hour; Add injection and be diluted with water to the required content of cefodizime sodium for injection preparation, the filtering with microporous membrane of reuse 0.45 μ m, by the filtering with microporous membrane of 0.22 μ m, packing promptly gets cefodizime sodium for injection/clavulanate potassium freeze-dried powder through lyophilization at last.
Embodiment 4:
Preparation technology:
Adding aseptic Cefodizime Sodium in the room temperature downhill reaction still is dissolved in the water for injection; Add aseptic clavulanate potassium, stir and make its whole dissolvings, get the aqueous solution of Cefodizime Sodium and clavulanate potassium mixture; In reactor, add HP-(HP-β-CD), stirred enclose 1.0 hours; Add injection and be diluted with water to required mass concentration, the filtering with microporous membrane of reuse 0.45 μ m, by the filtering with microporous membrane of 0.22 μ m, packing promptly gets cefodizime sodium for injection/clavulanate potassium freeze-dried powder through lyophilization at last.
Embodiment 5:
Preparation technology:
Adding aseptic Cefodizime Sodium in the room temperature downhill reaction still is dissolved in the water for injection; Add aseptic clavulanate potassium, stir and make its whole dissolvings, get the aqueous solution of Cefodizime Sodium and clavulanate potassium mixture; In reactor, add HP-(HP-β-CD), stirred enclose 2.0 hours; Add injection and be diluted with water to the required content of cefodizime sodium for injection preparation, the filtering with microporous membrane of reuse 0.45 μ m, by the filtering with microporous membrane of 0.22 μ m, packing promptly gets cefodizime sodium for injection/clavulanate potassium freeze-dried powder through lyophilization at last.
Embodiment 6:
Preparation technology:
Adding aseptic Cefodizime Sodium in the room temperature downhill reaction still is dissolved in the water for injection; Add aseptic clavulanate potassium, stir and make its whole dissolvings, get the aqueous solution of Cefodizime Sodium and clavulanate potassium mixture; In reactor, add HP-(HP-β-CD), stirred enclose 1.5 hours; Add injection and be diluted with water to the required content of cefodizime sodium for injection preparation, the filtering with microporous membrane of reuse 0.45 μ m, by the filtering with microporous membrane of 0.22 μ m, packing promptly gets cefodizime sodium for injection/clavulanate potassium freeze-dried powder through lyophilization at last.
Test example: (stability experiment)
1, sample preparation: the method according to embodiment 6 is prepared respectively; Control sample is commercially available sample cefodizime sodium for injection (Lu Ya pharmaceutical Co. Ltd in Shandong produces, lot number 20101006)
2, influence factor: sample is placed room temperature (25 ℃) respectively, high temperature (60 ℃), relative humidity 75% is under six kinds of conditions of relative humidity 92.5% and illumination 4500Lx.
3, investigate the result: investigate every index in sampling in the 5th day, 10 days, and be contrast, the results are shown in following table 1: factors influencing result with 0 day result
As seen from the above table, the sample of embodiment 6 and control sample contrast are as can be known, placed 5 days, 10 days under the condition of 25 ℃ of room temperatures, 60 ℃ of high temperature, relative humidity 75%, relative humidity 92.5% and illumination 4500Lx, the every index of the sample of embodiment 6 does not have significant change; The control sample related substance slightly raises, and it is following at 60 ℃ of high temperature and illumination (4500Lx) condition, related substance raises very fast, therefore Cefodizime sodium and clavulanate potassium salt of the present invention is behind the HP-enclose, increase the stability of Cefodizime sodium medicament, reduced its toxic and side effects, improved the drug utilization degree, and preparation technology is simple, is fit to suitability for industrialized production.
Claims (8)
1. Cefodizime composition of sodium, it is characterized in that: the said composition proportioning is counted by weight:
1～2 part of Cefodizime Sodium
2～6 parts of clavulanate potassium
HP-(HP-β-CD) 1～4 part.
2. compositions according to claim 1 is characterized in that: the said composition proportioning is counted by weight:
1～1.5 part of Cefodizime Sodium
2～4 parts of clavulanate potassium
HP-(HP-β-CD) 1～3 part.
3. compositions according to claim 1 and 2 is characterized in that: the said composition proportioning is counted by weight:
1～1.2 part of Cefodizime Sodium
2～3 parts of clavulanate potassium
HP-(HP-β-CD) 1～2 part.
4. compositions according to claim 1 is characterized in that: the said composition proportioning is counted by weight:
1～1.2 part of Cefodizime Sodium
2～2.4 parts of clavulanate potassium
HP-(HP-β-CD) 1～1.8 part.
5. Cefodizime Sodium preparation of compositions method as claimed in claim, it is characterized in that: its step is as follows:
1) the aseptic Cefodizime Sodium of adding prescription amount is dissolved in the water for injection in the room temperature downhill reaction still; The clavulanate potassium that adds the prescription amount afterwards stirs and makes its whole dissolvings, gets the aqueous solution of Cefodizime Sodium and clavulanate potassium;
2) in above-mentioned reactor, add HP-(HP-β-CD), the stirring at room enclose 0.5～2.0 hour of prescription amount; Add injection and be diluted with water to the required content of cefodizime sodium for injection preparation, the filtering with microporous membrane of reuse 0.45 μ m, by the filtering with microporous membrane of 0.22 μ m, packing gets the Cefodizime Sodium composite injection at last.
6. method according to claim 5 is characterized in that: the Cefodizime Sodium composite injection described step 2) promptly gets the cefodizime sodium for injection freeze-dried powder through lyophilization.
7. according to claim 5 or 6 described methods, it is characterized in that: the stirring at room enclose is 0.5～2.0 hour described step 2).
8. method according to claim 7 is characterized in that: the stirring at room enclose is 1.0～1.5 hours described step 2).
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| CN201110149456.0A CN102258521B (en) | 2011-06-03 | 2011-06-03 | Cefodizime Sodium composition and method of making the same |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201110149456.0A CN102258521B (en) | 2011-06-03 | 2011-06-03 | Cefodizime Sodium composition and method of making the same |
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| CN102258521B CN102258521B (en) | 2016-05-04 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103908673A (en) * | 2014-01-22 | 2014-07-09 | 邓学峰 | Ceftriaxone combinatorial drug |
| CN106309449A (en) * | 2016-08-24 | 2017-01-11 | 南昌立健药业有限公司 | Preparing method of cefodizime sodium for injection |
| CN107445978A (en) * | 2017-08-24 | 2017-12-08 | 艾美科健（中国）生物医药有限公司 | A kind of synthesis of cefalonium and purification process |
| CN109893663A (en) * | 2019-04-22 | 2019-06-18 | 苏州东瑞制药有限公司 | A kind of cefmetazole for injection composition and preparation method thereof |
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| US5608052A (en) * | 1992-07-08 | 1997-03-04 | Lek, Tovarna Farmacevtskih In Kemicnih | Inclusioin complexes of clavulanic acid and of alkali salts thereof with hydrophilic and hydrophobic beta-cyclodextrin derivatives, a process for the preparation thereof and the use thereof |
| US20040072798A1 (en) * | 2000-12-29 | 2004-04-15 | Annamaria Naggi | Compositions comprising cyclodextrins and no-releasing drugs |
| CN1565457A (en) * | 2003-06-21 | 2005-01-19 | 张哲峰 | Beta- lactamase suppressing antibacterial compound drugs |
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2011
- 2011-06-03 CN CN201110149456.0A patent/CN102258521B/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5608052A (en) * | 1992-07-08 | 1997-03-04 | Lek, Tovarna Farmacevtskih In Kemicnih | Inclusioin complexes of clavulanic acid and of alkali salts thereof with hydrophilic and hydrophobic beta-cyclodextrin derivatives, a process for the preparation thereof and the use thereof |
| US20040072798A1 (en) * | 2000-12-29 | 2004-04-15 | Annamaria Naggi | Compositions comprising cyclodextrins and no-releasing drugs |
| CN1565457A (en) * | 2003-06-21 | 2005-01-19 | 张哲峰 | Beta- lactamase suppressing antibacterial compound drugs |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103908673A (en) * | 2014-01-22 | 2014-07-09 | 邓学峰 | Ceftriaxone combinatorial drug |
| CN106309449A (en) * | 2016-08-24 | 2017-01-11 | 南昌立健药业有限公司 | Preparing method of cefodizime sodium for injection |
| CN107445978A (en) * | 2017-08-24 | 2017-12-08 | 艾美科健（中国）生物医药有限公司 | A kind of synthesis of cefalonium and purification process |
| CN107445978B (en) * | 2017-08-24 | 2019-06-18 | 艾美科健（中国）生物医药有限公司 | A kind of synthesis of cefalonium and purification process |
| CN109893663A (en) * | 2019-04-22 | 2019-06-18 | 苏州东瑞制药有限公司 | A kind of cefmetazole for injection composition and preparation method thereof |
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| CN102258521B (en) | 2016-05-04 |
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