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Cefuroxime sodium powder preparation for injection

A technology of cefuroxime sodium and fururoxime sodium powder, which is applied in the direction of medical preparations containing active ingredients, powder delivery, antibacterial drugs, etc., and can solve the problems of poor stability and color of cefuroxime sodium that affect the quality and safety of drugs. Rapid changes and other issues, to achieve the effect of improving the national health level, significant social benefits, and good color of the finished product

Active Publication Date: 2017-02-01
NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Cefuroxime sodium products generally have the problem of poor stability, mainly reflected in the rapid color change, which affects the quality and safety of drugs

Method used

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  • Cefuroxime sodium powder preparation for injection

Examples

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preparation example Construction

[0023] Step A, preparation of aseptic sodium agent solution: stir and dissolve anhydrous sodium acetate in a reaction tank with methanol, then add an adsorbent to stir and decolorize, filter, and aseptically treat to obtain a sterile sodium agent solution for subsequent use;

[0024] Step B. Preparation of sterile cefuroxime acid solution: add acetone and water into a dry and clean dissolving tank, stir and add cefuroxime acid to dissolve under nitrogen protection conditions, then add an adsorbent and stir to decolorize, filter, and aseptically treat to obtain Sterile cefuroxime acid solution, standby;

[0025] Step C, crystallization: add a small amount of acetone to the crystallization tank, control the temperature at 8-10°C, and add the sterile sodium-forming agent solution prepared in step A and the sterile cefuroxime prepared in step B to the crystallization tank at the same time for 2-4 hours Caprylic acid solution and acetone, and then grow the crystal for 0.8-1.5h once...

Embodiment 1

[0036] Step A, preparation of aseptic sodium agent solution: Stir and dissolve 18Kg anhydrous sodium acetate in a stainless steel reaction drying tank with 200L methanol, then add 5Kg adsorbent and stir at 10°C for 30min, filter, and aseptically treat to obtain aseptic product Sodium solution, spare;

[0037] Step B. Preparation of sterile cefuroxime acid solution: add 750L of acetone and 60L of purified water into a dry and clean dissolving tank, stir and add 85Kg of cefuroxime acid until dissolved under nitrogen protection, then add 5Kg of adsorbent and stir at 10°C for 30min to decolorize , filtered, aseptically processed, and pressed into a sterile cefuroxime acid solution tank to obtain a sterile cefuroxime acid solution for subsequent use;

[0038] The adsorbent in step A and step B is activated carbon or wood fiber or a mixture of the two, the stirring speed of the adsorbent is 60r / min, the filter is decarburized by 3-8μm titanium rod, and the aseptic treatment is to pa...

Embodiment 2

[0042] The difference between this embodiment and embodiment 1 is:

[0043] The stirring speed of the adsorbent in step A and step B is 40r / min, and a 6-8μm titanium rod is used for filtration and decarburization.

[0044] Step C, crystallization: After adding 50L of acetone to the crystallization tank, control the temperature of the crystallization tank at 9°C, and add the sterile sodium forming agent solution in step A and the sterile cefuroxime acid solution in step B to the crystallization tank at the same time for 4 hours and 1000L acetone for 1.3 hours of crystal growth; then continue to add 1500L of acetone in the form of gradient drop for 1.5 hours, and lower the temperature of the crystallization tank to 1°C for the second crystal growth of 1.8h, and then filter and wash the crystal grains Drying makes it loose, and the loose crystal grains are transferred to a vacuum dryer for drying, and after passing the inspection, cefuroxime sodium sterile powder bulk drug for in...

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Abstract

The invention discloses a cefuroxime sodium powder preparation for injection, belonging to the technical field of medicine preparation. The cefuroxime sodium powder preparation for injection is prepared by the following steps: preparation of a sterile formed sodium agent solution, preparation of a sterile cefuroxime acid solution, crystallization and sub-packaging, wherein a two-time grain growing technology is adopted for the crystallization, so that the crystallization quality is improved. With good color and high stability, the product disclosed by the invention greatly improves the quality and safety of cefuroxime sodium, is favorable for improving the national health level, and realizes remarkable economic and social benefits.

Description

technical field [0001] The invention relates to a cefuroxime sodium powder preparation for injection, which belongs to the technical field of medicine preparation. Background technique [0002] In the national scientific and technological major special project task of "Innovative Drug Incubation Base of High-end Pharmaceutical Industrial Park" actively undertaken by North China Pharmaceuticals - major new drug creation special project, because this topic is related to the health of our country, the project was set up to carry out research and development of microbial drugs and biotechnology drugs. The research on the industrialization system aims to improve the crystallization technology platform of antibiotic drugs, carry out the research on the crystallization process of cefuroxime sodium and apply it to large-scale production, so as to fill the gap in domestic production. [0003] Cefuroxime sodium, as the second-generation cephalosporin antibiotic, has been developed and...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/546A61K47/08A61P31/04
CPCA61K9/14A61K31/546A61K47/08
Inventor 杨梦德胡利敏蒋晓声张锁庆张文胜刘萍王智马亚微孙玉双徐薇薇杨轩
Owner NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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