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Preparation of cefazolin sodium sterilized raw medicine

A technology for cefazolin sodium and bulk drug, which is applied in the field of preparation of cefazolin sodium aseptic bulk drug, can solve the problems of high, difficult to control substances and the like, and achieves the effects of simple method, easy operation and stable quality

Inactive Publication Date: 2009-06-24
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The object of the present invention is to provide a kind of preparation method of cefazolin sodium aseptic raw material drug, solve the problem that cefazolin sodium moisture, clarity are difficult to control and related substances are on the high side in the existing production technology

Method used

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  • Preparation of cefazolin sodium sterilized raw medicine
  • Preparation of cefazolin sodium sterilized raw medicine
  • Preparation of cefazolin sodium sterilized raw medicine

Examples

Experimental program
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Effect test

Embodiment 1

[0023] Suspend 5.0 g of cefazolin in 50 ml of deionized water, and neutralize with saturated sodium bicarbonate solution to pH = 4.5 in a stirred, airtight container with a water bath at a constant temperature of 45°C and under reduced pressure (the water pump pressure gauge indicates 0.01Mpa). , the solution is clear and transparent, add 0.1 g of activated carbon and continue to stir for 15 minutes to decolorize. After the filter cloth is filtered to remove the activated carbon, the filtrate is then filtered with a 0.22 μm microporous filter membrane. Control the thickness of the solution to 1.0cm, freeze the product to -30°C, keep it for 1 hour, pump a vacuum, keep the vacuum at 0-10Pa, raise the temperature to 40°C, keep it for 5 hours, and the freeze-drying is completed. Out of the box, pulverized, and aseptically packaged to obtain cefazolin sodium 5.2g. Yield 99.0%, (theoretical value 5.25g), moisture is 0.9%, content is 99.5% in terms of dry product; Related substances ...

Embodiment 2

[0025] 2500g of cefazolin was neutralized to pH=5.4 with 8% sodium bicarbonate solution in a water bath with constant temperature of 35°C and reduced pressure (indicating 0.082Mpa on the water pump pressure gauge) in a stirred and airtight container. The solution was clear and transparent, and the constant temperature was continued. After reacting for 30 minutes, the reaction solution was filtered with a titanium rod in a 10,000-class clean area to remove activated carbon, and the filtrate was filtered with a 0.22 μm microporous membrane in a local 100-class aseptic area, and the obtained filtrate was poured into a freeze-drying tray, and the thickness of the solution was controlled to be 2.0cm, freeze the product to -40°C, keep it for 3 hours, vacuumize, keep the vacuum at 20-35Pa, then raise the temperature to 50°C, keep it for 5 hours, then keep the vacuum at 0-10Pa for 4 hours, and the freeze-drying is over . Out of the box, pulverized, and aseptically packaged to obtain 2...

Embodiment 3

[0027] 2500g of cefazolin was neutralized to pH=8.0 with 1% sodium hydroxide solution under constant temperature of water bath at 30°C and reduced pressure (indicating 0.062Mpa on the water pump pressure gauge) in a stirred and airtight container, the solution was clear and transparent, and activated carbon was added 65g continued to stir and decolorize for 120min. After the reaction liquid was filtered with a titanium rod to remove the activated carbon in a 10,000-class clean area, the filtrate was filtered with a 0.22μm microporous membrane in a local 100-class aseptic area, and the obtained filtrate was poured into a freeze-drying tray. Control the thickness of the solution to 1.5cm, freeze the product to -35°C, keep it for 9 hours, then maintain the vacuum at 0-10Pa for 3 hours, then pump the vacuum and maintain the vacuum at 20-35Pa for sublimation, then raise the temperature to 50°C, keep After 12 hours, freeze-drying was completed. Out of the box, pulverized, and asepti...

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Abstract

The invention provides a preparation method of a cefazolin sodium sterile bulk drug. The preparation method comprises the following steps: suspending cefazolin in deionized water, performing a neutralization reaction with alkali solution containing sodium ions in a hermetic stirring container under depressurized condition, and obtaining the cefazolin sodium sterile bulk drug by rough filtration, sterile filtration and lyophilization of reaction liquid.. The preparation method solves the technical problems of the existing production process that the clarity and the water content of the cefazolin sodium are difficult to be controlled and the contents of related materials are too much higher, improves the product quality and is suitable for large-scale industrialized production.

Description

technical field [0001] The invention relates to a preparation method of cefazolin sodium, in particular to a preparation method of cefazolin sodium aseptic bulk drug. Background technique [0002] The chemical name of cefazolin sodium is (6R,7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-7-[(1H- Tetrazol-1-yl)acetamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt, the English name is Cefazolin sodium salt; Ancef ; Kefzol; Zolicef, English chemical name is: 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[[(5-methyl-1,3,4-thiadiazol- 2-yl)thio]methyl]-8-oxo-7-[(1H-tetrazol-1-ylacetyl)amino]-, monosodium salt, (6R, 7R)-, molecular formula, C 14 h 13 N 8 NaO 4 S 3 , molecular weight 476.48, CA registration number: 27164-46-1, its chemical structural formula: [0003] [0004] Cefazolin sodium is a first-generation cephalosporin with a broad antibacterial spectrum. Except for Enterococcus and methicillin-resistant Staphylococ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/36A61K31/546A61P31/04
Inventor 刘永红杨戈刘黎
Owner YAOPHARMA CO LTD
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