CN101669956B - Composition of cefoxitin acid - Google Patents
Composition of cefoxitin acid Download PDFInfo
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- CN101669956B CN101669956B CN2009100440119A CN200910044011A CN101669956B CN 101669956 B CN101669956 B CN 101669956B CN 2009100440119 A CN2009100440119 A CN 2009100440119A CN 200910044011 A CN200910044011 A CN 200910044011A CN 101669956 B CN101669956 B CN 101669956B
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- cefoxitin
- cefoxitin acid
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Abstract
The invention relates to a cefoxitin acid composition which is characterized by comprising the combination of cefoxitin acid and arginine. The preparation method of the composition mainly comprises the following steps: weighing the aseptic raw material medicines of the cefoxitin acid and the arginine according to the proportion of a recipe in an aseptic environment, mixing evenly and then subpackaging. The composition solves the problem that the active component of the cefoxitin acid is not dissolved in water, also solves the problem that the original medicine of cefoxitin sodium is unstable, can effectively lower the impurity content and obviously enhance the stability of a product, thereby reducing the generation rate of side reactions, such as anaphylactic reactions, effectively; a safety testing result shows that compared with the original pharmaceutical preparation, the preparation has smaller local irritability and very important clinical application value.
Description
Invention field
The present invention relates to a kind of compositions of antibiotic cefoxitin acid, belong to pharmaceutical field.
Background technology
MK-306 (Cefoxitin Sodium) belongs to the cephamycin-type antibiotic; Its parent nucleus is similar with cephalosporin; It is the semi-synthetic cephalosporins antibiotic of U.S. Merck company initiative; By Japanese first pharmacy exploitation, get the Green Light with the Cenomycin trade name in August, 1979, and these article advantage is stable to beta-lactamase.Its chemistry is by name: (6R, 7S)-3-[(1-carbamyl oxygen) methyl]-7-methoxyl group-8-oxo-7-[2-(2-thienyl) acetylamino]-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-formic acid sodium salt.
Its structural formula is:
Its active component cefoxitin acid is water-soluble hardly, during its sodium salt is then soluble in water, uses for convenient injection clinically, therefore processes pharmaceutical dosage forms with its sodium salt.But sodium salt is unstable, changes soon in the storage, and impurity raises easily, and content reduces easily, requires preferably to preserve at cold place.
Be the control product quality; Reduce incidence rate of adverse reaction such as allergy; Chinese Pharmacopoeia is to the important indicator of cefoxitin sodium raw materials and preparation quality standard: solution colour, to revise, and the requirement of 2005 editions Chinese Pharmacopoeia solution colours is brought up to standard color solution No. 7 officinal No. 10 from former 95 editions.And the MK-306 that now circulation is used on the market often is verified out defectively, and great majority all are because the solution colour item exceeds standard, and do not reach the requirement of quality standard.
MK-306 on the market is if pressing the shady and cool place of existence conditions preserves, and solution colour all surpasses standard color solution No. 8 after general half a year, preserves so the new edition pharmacopeia is planned MK-306 storage condition revision to cold place, to guarantee product quality.But, and greatly improve and store and cost of transportation like this to the using and store all and will make troubles of this product.
Goal of the invention
The object of the present invention is to provide the more stable cefoxitin acid composition of a kind of product quality, to overcome side reaction such as the more high defective of irritated rate in its existing pharmaceutical preparation poor stability, impurity content problem of higher and the clinical use.The present invention improves the quality of products and stability, especially is embodied in the important indicator of quality standard: solution colour, significantly improve, and can guarantee that the color of solution was no more than No. 7 standard color solutions of standard code existing storage conditions 2 years.
The invention has the advantages that: 1, said composition can solve the problem that cefoxitin acid is insoluble in water; Also can solve former medicine MK-306 problem of unstable; Storage to medicine does not have specific (special) requirements; The content of impurity in the transporting procedures be can effectively reduce, thereby side reaction such as anaphylactoid incidence rate effectively reduced; 2, show through medicine stability test (40 ℃ accelerated test 1 month) result: the color of said composition solution is shallower than yellow No. 5 standard color solutions, and the color of MK-306 is deeper than yellow No. 9 standard color solutions, has not met the quality standard regulation; 3, compare with other compositions (like cefoxitin and sodium carbonate or sodium bicarbonate), can not produce Co during the clinical use of said composition
2Gas has been avoided because the improper risk that causes liquid medicine contamination of bleeding has been avoided Co in the infusion process simultaneously
2Stripping produces bubble and makes the danger that forms gas embolism in the blood samples of patients, and the danger of the too high generation bottle explosion of bottle internal gas pressure can avoid preparating liquid the time, thereby clinical more secure when used, more convenient.4, said composition is not owing to contain sodium ion, and the absorption patient who makes needs such as heart disease, hypertension, nephropathy, edema patient, neonate, anemia of pregnant woman and old people limit sodium ion uses safer, and local irritation is littler; Simultaneously arginine can produce optimum effect to immunity, blood circulation and the hormonal system of body in the said composition, improves immunologic function, the promotion wound healing after can making serious wound, burn, major operation.5, said composition is compared with the compositions of sodium carbonate or sodium bicarbonate with cefoxitin acid, and except that aerogenesis not, stability is obviously better.Confirm through test; After the said composition dissolving; Solution colour is at No. 2 standard color solutions; Be no more than standard color solution No. 3; And Cefoxitin and sodium carbonate composition (are regulated proportioning; Allow solution pH value after the dissolving about 7), dissolving back solution colour is at No. 4 or No. 5 standard color solutions, and it is former relevant with the heat release afterwards that is dissolved in water of sodium carbonate composition in response to being cefoxitin acid.Through comparing, after at room temperature this compositions was dissolved in water, solution temperature did not have significant change, and cefoxitin acid and sodium carbonate or sodium bicarbonate compositions, after being dissolved in water, the temperature of solution obviously raises.
Summary of the invention
The invention provides a kind of cefoxitin acid and arginic compositions.Concrete method for making is: under gnotobasis, take by weighing cefoxitin acid and arginine sterile bulk drug according to the prescription ratio, pour in the efficient three-dimensional motion mixer fully mix homogeneously into after, divide and pack, promptly get.
The specific embodiment
Further set forth the present invention through embodiment below, but do not limit the present invention.
Embodiment 1
In aseptic batch plant, take by weighing aseptic cefoxitin acid crude drug 35.5kg and arginine crude drug 14.5kg, pour in the efficient three-dimensional motion mixer, be 5 rev/mins with rotating speed and mixed about 1.5 hours that behind the mix homogeneously, discharging divides packing, promptly gets.
Embodiment 2
In aseptic batch plant, take by weighing aseptic cefoxitin acid crude drug 35kg and arginine crude drug 15kg, pour in the efficient three-dimensional motion mixer, be 5 rev/mins with rotating speed and mixed about 1.5 hours that behind the mix homogeneously, discharging divides packing, promptly gets.
Claims (1)
1. the compositions of a cefoxitin acid is characterized in that said composition is cefoxitin acid and arginic combination, and described cefoxitin acid and arginic weight ratio are 1: 0.41; And process: in aseptic batch plant, take by weighing aseptic cefoxitin acid crude drug and arginine crude drug, pour in the efficient three-dimensional motion mixer through following method; Be 5 rev/mins with rotating speed and mixed 1.5 hours, behind the mix homogeneously, discharging; Divide packing, promptly get.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009100440119A CN101669956B (en) | 2009-07-31 | 2009-07-31 | Composition of cefoxitin acid |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009100440119A CN101669956B (en) | 2009-07-31 | 2009-07-31 | Composition of cefoxitin acid |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101669956A CN101669956A (en) | 2010-03-17 |
| CN101669956B true CN101669956B (en) | 2012-07-18 |
Family
ID=42017516
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2009100440119A Expired - Fee Related CN101669956B (en) | 2009-07-31 | 2009-07-31 | Composition of cefoxitin acid |
Country Status (1)
| Country | Link |
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| CN (1) | CN101669956B (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102526741A (en) * | 2010-12-09 | 2012-07-04 | 单爱莲 | Composition of arginine and series of cephalosporin acids |
| CN102895182B (en) * | 2012-10-22 | 2013-10-16 | 四川制药制剂有限公司 | Method for preparing cefoxitin sodium for injection |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1119531A (en) * | 1994-08-03 | 1996-04-03 | 明治制果株式会社 | A stably storable and readily water soluble composition of cephalosporin for injections |
-
2009
- 2009-07-31 CN CN2009100440119A patent/CN101669956B/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1119531A (en) * | 1994-08-03 | 1996-04-03 | 明治制果株式会社 | A stably storable and readily water soluble composition of cephalosporin for injections |
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| Publication number | Publication date |
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| CN101669956A (en) | 2010-03-17 |
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Addressee: Zhou Gewen Document name: Notification of Passing Preliminary Examination of the Application for Invention |
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| C06 | Publication | ||
| PB01 | Publication | ||
| DD01 | Delivery of document by public notice |
Addressee: Zhou Gewen Document name: Notification of Publication of the Application for Invention |
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Granted publication date: 20120718 Termination date: 20130731 |