Method for preparing cefathiamidine freeze-dried sterile raw material medicine

A technology of cefathiamidine and raw material medicine, which is applied in the field of preparation of cefathiamidine freeze-dried sterile raw material medicine, can solve the problems of increasing production cost, affecting product quality, low yield, etc., and achieves low production cost, transportation or storage The effect of convenience and stable drug quality

Inactive Publication Date: 2005-05-18
济南永曜医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the yield of this method is generally not high, which increases the production cost; and the organic solvent of the residual part is more or less, thereby affecting the quality of the product

Method used

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  • Method for preparing cefathiamidine freeze-dried sterile raw material medicine

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Accurately weigh 50g of non-sterile cefathiamidine (prepared by the method in US Pat. After 20 minutes, perform sterile filtration, transfer the resulting filtrate to a freeze-drying tray, and freeze-dry according to the freeze-drying process conditions. In the final stage of freeze-drying, when the temperature is raised to about 25°C, the vacuum degree does not change within 1 hour. 48.8g of the product was prepared, the water content was 2.5%, and the yield was 97.6%.

Embodiment 2

[0024] Accurately weigh 50g of non-sterile cefathiamidine (prepared by the method in U.S. Patent No. 3,646,025), dissolve it in 500 ml of water for injection under aseptic, room temperature and mechanical stirring, and add 2g of activated carbon for decolorization After 25 minutes, perform sterile filtration, transfer the resulting filtrate to a freeze-drying tray, and freeze-dry according to the freeze-drying process conditions. In the final stage of freeze-drying, when the temperature is raised to about 25°C, the vacuum degree does not change within 3 hours. 49.0 g of the product was prepared, the water content was 1.8%, and the yield was 98.0%.

Embodiment 3

[0026] Accurately weigh 50 g of non-sterile cefathiamidine (prepared by the method in U.S. Patent No. 3,646,025), dissolve it in 500 ml of water for injection under aseptic, room temperature, and mechanical stirring, and add 1 g of activated carbon for decolorization After 30 minutes, perform sterile filtration, transfer the resulting filtrate to a freeze-drying tray, and freeze-dry according to the freeze-drying process conditions. In the final stage of freeze-drying, when the temperature is raised to about 25°C, the vacuum degree does not change within 5 hours. 49.2 g of the product was prepared, the water content was 0.7%, and the yield was 98.4%.

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Abstract

The present invention relates to preparation process of freeze dried sterile cefathiamidine as raw medicine material, and solves the problems of raising cefathiamidine yield and eliminating organic solvent residue. The technological scheme includes dissolving cefathiamidine in proper amount of water for injection at room temperature, adding proper amount of medicinal carbon to decolor for 20-30 min, sterile filtering and freeze drying to water content 0.1-3 wt% and to obtain product. The weight ratio between cefathiamidine and water for injection is 1 to 1-10, and the weight ratio between cefathiamidine and active carbon is 1 to 0.01-0.1. The present invention has simple production process, low production cost, low organic solvent residue, high yield over 97 %, stable medicine quality, and convenient transportation and storing.

Description

technical field [0001] The invention relates to a method for producing an antibiotic cefathiamidine freeze-dried aseptic bulk drug. Background technique [0002] Cefathiamin is a β-lactam antibiotic and belongs to the first generation of cephalosporins for injection. After absorption, it is widely distributed in various organs and tissues, and is mainly excreted by the kidneys. to G + Bacteria are more effective than G - It has strong inhibitory effect on Staphylococcus aureus (including penicillin-resistant strains), Streptococcus viridans, Streptococcus pneumoniae, etc., and has a good antibacterial effect on Enterococcus. It is mainly used clinically for Staphylococcus aureus (including Penicillin-resistant strains), Streptococcus pneumoniae and other infections are also better for urinary tract infections. [0003] Cefathiamidine is also called cephalosporin-18, cephalosporin pyramidine, and cephalosporin thiamidine. [0004] Chemical name: 7-(N, N'-Diisopropylamidi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/382A61K31/545A61P31/04
Inventor 姚松芝郭雷楼志腾
Owner 济南永曜医药科技有限公司
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