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Preparation method of Cefamandole Nafate powder injection for injection

A technology for sodium montorolide powder and injection, which is applied in the field of preparation of raw materials, can solve the problems affecting the reaction efficiency of cefamandide sodium powder injection preparation and the quality of products, and achieves the advantages of improving quality and simplifying the operation process. Effect

Inactive Publication Date: 2017-03-22
NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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  • Claims
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Problems solved by technology

[0004] During the research on the production of cefamandole sodium, the reaction efficiency and product quality of the cefamandole sodium powder injection preparation were affected by the improvement of the 7-ACA fermentation method of the raw material. At present, there is a lack of a way to improve the reaction of the product. Efficiency and quality of production response technology methods

Method used

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  • Preparation method of Cefamandole Nafate powder injection for injection

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preparation example Construction

[0048] The preparation of 7-ATCA: to acetonitrile, methylmercaptotetrazolium, B 3 Add 7-ACA to F-acetonitrile, stir and dissolve to obtain a solution, raise the temperature to 35°C, react for 2-3 hours and then cool down to 5°C, transfer the solution into pre-cooled purified water, stir slowly and use 10% ammonia water Adjust the pH to 3.0, grow crystals at 0-5°C for 90 minutes, filter and dry to obtain 7-ATCA;

[0049] Preparation of Cefamandoleic Acid: Add 7-ATCA to ethyl acetate, add N,O-bistrimethylsilylacetamide under stirring, heat up to 35°C, react for 3-4 hours until clear, then cool down to -10°C , add formylmandelic acid chloride dropwise to the system, raise the temperature to 0°C, react for 60 minutes, add purified water and stir, then let it stand still; dehydrate the organic phase with anhydrous magnesium sulfate, decolorize with activated carbon and filter, and concentrate the filtrate to obtain cephalosporin mentelate acid solution;

[0050] The prepara...

Embodiment 1

[0054] ① Strain preparation: Return the preserved frozen tube to room temperature and apply the slanted surface. After culturing for 7 days, refrigerate at 27°C. When using, pour sterile water into the slanted seeds to make a seed solution;

[0055] ②Preparation and cultivation of the seed tank: In the batching tank 1, one or several kinds of peanut cake powder, bean cake powder, glucose, and corn steep liquor are fed, and after feeding, the batching tank is pressed into the seed tank, and the seed tank is steamed. The temperature is high temperature sterilization at 121°C, and the feed liquid is cooled to 27°C with refrigerant water; the spore liquid obtained after the seed liquid in step ① undergoes sporulation fermentation, the spore liquid is connected to the primary seed tank The ventilation rate is 1:0.8, the temperature is 27 ° C, and the cultivation time is 80 hours under the conditions of pH 6.8; transplanted to the second-level seed tank, the spore liquid is in the se...

Embodiment 2

[0069] ① Strain preparation: Return the preserved frozen tube to room temperature and apply the slanted surface. After cultivating for 8 days, refrigerate at 28°C. When using, pour sterile water into the slanted seeds to make a seed solution;

[0070] ②Preparation and cultivation of the seed tank: In the batching tank 1, one or several kinds of peanut cake powder, bean cake powder, glucose, and corn steep liquor are fed, and after feeding, the batching tank is pressed into the seed tank, and the seed tank is steamed. The temperature is high temperature sterilization at 122°C, and the feed liquid is cooled to 28°C with refrigerant water; the spore liquid obtained after the seed liquid in step ① undergoes sporulation fermentation, the spore liquid is connected to the primary seed tank The ventilation rate is 1:1.0, the temperature is 28 ° C, and the cultivation time is 90 hours under the conditions of pH 7.0; transplanted to the second-level seed tank, the spore liquid is in the ...

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Abstract

The invention discloses a preparation method of a Cefamandole Nafate powder injection for injection. The method includes the steps of: (1) strain preparation; (2) preparation and culture of seed tank; (3) preparation and culture of a fermentation tank; (4) filtration; (5) decolorization and concentration; (6) preparation of a reaction tank and pipeline; (7) preparation of enzyme catalytic reaction; (8) enzyme catalytic reaction; (9) crystallization; (10) centrifugation and vacuum drying; (11) preparation of 7-ATCA; (12) preparation of cefamandole acid; (13) preparation of Cefamandole Nafate; and (14) aseptic subpackaging, thus obtaining the Cefamandole Nafate powder injection for injection. The invention provides the method of improving the 7-ACA preparation process so as to improve the product quality of cefamandole.

Description

technical field [0001] The invention relates to a preparation method of cefamandole sodium powder preparation for injection, which belongs to the field of raw material medicine preparation. Background technique [0002] Cefamandole sodium, as a relatively large variety of cephalosporins, has huge market potential at present, and this product is the second-generation cephalosporin antibiotic. Its structural formula is: [0003] The chemical name of this product is: (6R, 7R)-7(R)-(2-formyloxy-2-phenylacetamido]-3[[(1-methyl-1H-tetrazol-5-yl) )Thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. Calculated as anhydrous matter, containing cefamen More (C18H17N6NaO6S2) 84.0% to 93.0%. [0004] During the research on the production of cefamandole sodium, the reaction efficiency and product quality of the cefamandole sodium powder injection preparation were affected by the improvement of the 7-ACA fermentation method of the raw material. At prese...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/546A61P31/04C07D501/36C07D501/04C07D501/12
CPCA61K9/19A61K9/0019A61K31/546C07D501/04C07D501/12C07D501/36
Inventor 孙燕胡利敏张锁庆杨梦德李敏杨宏硕马亚松米建伟张致一黄晶李雪元
Owner NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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