Title:
PROCESS FOR PREPARING CEFAZOLIN SODIUM FOR INJECTION
Document Type and Number:
WIPO Patent Application WO/2023/070822
Kind Code:
A1
Abstract:
Provided is a process for preparing Cefazolin sodium for injection, comprising the following steps: (1) adding dichloromethane into a Cefazolin sodium crude product, adding chitosan, then adding sodium ethoxide and 5-ethyl-2-methylpyridine, stirring for 1.5-2.5 h at a temperature of 8-10°C, and filtering to obtain a solution A; (2) adding disodium ethylenediamine tetraacetic acid and ethanol into the solution A, cooling, crystallizing, drying, dissolving in water, filtering, and sterilizing to obtain a Cefazolin sodium raw material, adding glycerol, L-cysteine and xylan, and performing vacuum freeze-drying to obtain cefazolin sodium for injection; and (3) respectively cleaning and sterilizing penicillin bottles, rubber plugs and aluminum caps, sub-packaging the Cefazolin sodium for injection into the penicillin bottles, pressing the plugs and capping to obtain a target product. By using the preparation method, impurities are effectively removed while avoiding introduction of new impurities, the content of related substances is reduced, and the hygroscopicity of a drug is reduced.
Inventors:
LU YIFENG (CN)
LU GUORONG (CN)
CHEN XINGYU (CN)
LU GUORONG (CN)
CHEN XINGYU (CN)
Application Number:
PCT/CN2021/134861
Publication Date:
May 04, 2023
Filing Date:
December 01, 2021
Export Citation:
Assignee:
HAINAN HAILING CHEMIPHARMA CORP LTD (CN)
International Classes:
A61K9/19; A61K9/00; A61K31/04; A61K31/546; A61K47/10; A61K47/18; A61K47/36; C07D501/12; C07D501/36
Domestic Patent References:
| WO2002030469A2 | 2002-04-18 |
Foreign References:
| CN110894197A | 2020-03-20 | |||
| CN106432276A | 2017-02-22 | |||
| CN111548357A | 2020-08-18 | |||
| CN113398072A | 2021-09-17 | |||
| CN104610282A | 2015-05-13 |
Attorney, Agent or Firm:
HAINAN HEIP INTELLECTUAL PROPERTY AGENCY CO., LTD (CN)
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