Composition of cefmetazole acid

A technology of cefmetazole acid and its composition, which is applied in the field of drug preparation, can solve the problems of high side effects and allergy rate, easy increase of related substances, high content of impurities, etc., achieve easy purification, reduce the incidence of allergic reactions, and reduce impurities The effect of content

Inactive Publication Date: 2009-10-07
国药集团致君(苏州)制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It aims to overcome the defects of poor stability, easy increase of related substances, high impurity content, side effects and high allergy rate during use in the existing technology.

Method used

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  • Composition of cefmetazole acid

Examples

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Effect test

example 1

[0010] Cefmetazole acid sterile powder is used, the particle size is adjusted, mixed with arginine sterile powder at a weight ratio of 1:0.35 to 1:0.70, and dissolved in water. The specific steps are as follows: in the aseptic batching workshop, weigh 50 kg of cefmetazole acid and arginine aseptic raw materials with a ratio of 1:0.35 to 1:0.70, and pour them into a high-efficiency three-dimensional motion mixer. Set the speed of the three-dimensional powder mixer to 5 rpm, and start the powder mixing operation according to the existing powder mixing packaging standard operating procedures. After mixing for about 60min to 90min, the material is discharged and packaged separately.

[0011] The optimum weight ratio is 1:0.40. Because its molar ratio is about 1:1, its pH is about 7±1, which is close to neutral, which is beneficial for injection. Otherwise, if the pH is too high or too low, it will stimulate the intravenous injection.

example 2

[0013] Cefmetazole acid sterile powder is used, the weight ratio of particle size and sodium carbonate sterile powder is adjusted to be 1:0.13-1:0.20, mixed and dissolved in water. The specific steps are as follows: in the aseptic batching workshop, weigh 50 kg of cefmetazole acid and sodium carbonate aseptic raw materials in a ratio of 1:0.13 to 1:0.20, and pour them into a high-efficiency three-dimensional motion mixer. Set the speed of the three-dimensional powder mixer to 5 rpm, and start the powder mixing operation according to the powder mixing packaging standard operating procedures. After mixing for about 60min to 90min, the material is discharged and packaged separately.

[0014] The optimum weight ratio is 1:0.14. Because its molar ratio is about 1:1, its pH is about 7±1, which is close to neutral, which is beneficial for injection. Otherwise, if the pH is too high or too low, it will stimulate the intravenous injection.

example 3

[0016] Cefmetazole acid sterile powder is used, the weight ratio of particle size and sodium bicarbonate sterile powder is adjusted to be 1:0.18-1:0.25, and the mixture is dissolved in water. The specific steps are as follows: In the aseptic batching workshop, weigh 50 kg of cefmetazole acid and sodium bicarbonate sterile raw materials with a ratio of 1:0.18 to 1:0.25, and pour them into a high-efficiency three-dimensional motion mixer. Set the speed of the three-dimensional powder mixer to 5 rpm, and start the powder mixing operation according to the standard operating procedures for powder mixing packaging. Mix until about 60min to 90min and mix evenly, then discharge and pack separately.

[0017] The optimum weight ratio is 1:0.19. Because its molar ratio is about 1:1, its pH is about 7±1, which is close to neutral, which is beneficial for injection. Otherwise, if the pH is too high or too low, it will stimulate the intravenous injection.

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Abstract

The invention relates to a composition of a cefmetazole acid, which is characterized in that the mix of cefmetazole acid and arginine aseptic powders with the weight ratio of 1: 0.35 to 1:0.70 is dissolved in water. The invention includes the detail steps of weighting 50kg material drug of cefmetazole acid and arginine aseptic powders by the weight percentage of 1: 0.35 to 1:0.70; pouring the material drug in a three-dimensional motion mixer and setting the rotating speed of the three-dimensional motion into 5 rotation per minute; well mixing the material drug for 60 minutes to 90 minutes; discharging the material and sub-packaging the material. The invention has the advantages that the composition improves the quality of products and reduces impurities, the composition markedly improves the stability of product, effectively reduces the content of impurities and solves the problem of water insolvability, and cefmetazole acid is more stable than cefmetazole sodium and can be purified easily; if cefmetazole acid is used to obtain preparation together with arginine proportionally, the all relative material can be stabilized in 2 percent for a long time, thereby reducing the incidence rate of side effects and allergy and achieving actual meaning and value.

Description

technical field [0001] The invention relates to a composition of an antibiotic cefmetazole and belongs to the technical field of medicine preparation. Background technique [0002] Cefmetazole Sodium (Cefmetazole Sodium) was originally a new type of cephalosporin antibiotic independently developed by Sankyo Company. Sankyo acquired a license under the trade name of Cefmetazon in August 1978, and began selling injections in February 1980. The chemical name of cefmetazole sodium is: (6R-cis)-7-[[[(cyanomethyl)sulfur]acetyl]amino]-7-methoxy-3-[[(1-methyl-1H- 5-tetrazolyl)thio]-methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. [0003] The structural formula is as follows: [0004] [0005] Its active ingredient is cefmetazole acid, but it is insoluble in water, so for the convenience of use, it is prepared in the form of its sodium salt. Use cefmetazole acid to add sodium carbonate or sodium bicarbonate to form a sodium salt, adjust the pH ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K47/16A61K47/02A61K9/14A61P31/00
Inventor 王磊闫志刚史利军
Owner 国药集团致君(苏州)制药有限公司
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