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Production process of mezlocillin sodium

A mezlocillin sodium and production process technology, which is applied in the field of drug synthesis, can solve the problems of non-compliance, high content of product polymers and impurities, and achieve improved yield, low content of mezlocillin sodium polymers and impurities, and ease of use and good medicinal properties

Inactive Publication Date: 2014-09-24
JIANGSU HI STONE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The traditional preparation methods of mezlocillin sodium are reaction crystallization and freeze-drying, and the products prepared by them have high content of polymers and impurities, which do not meet the requirements of the new Chinese Pharmacopoeia compiled by the National Pharmacopoeia Committee

Method used

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  • Production process of mezlocillin sodium
  • Production process of mezlocillin sodium
  • Production process of mezlocillin sodium

Examples

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Embodiment 1

[0030] Calculated on the basis of 150kg batch of mezlocillin converted into scalar amount

[0031] (1) Cleaning, sterilization and inspection of reaction equipment and workplaces;

[0032] Before the start of production, check that there are no products, documents or materials unrelated to the production of this batch of products left over from the previous batch in the equipment and workplace, and the equipment is in a cleaned and ready-to-use state. The operator checks and confirms that the salt tank and delivery pump are in good condition; confirms that the pipelines, valves, decarbonization filters, plate and frame filters, and precision filters are in good condition; Clean and disinfect the reaction conveying system according to the operating procedures (SOP-EC-007);

[0033] (2) Preparation of sodium bicarbonate suspension: prepare sodium bicarbonate suspensions with a mass concentration of 13.5-14.5% and a mass concentration of 12.5-13.5% with water for injection, resp...

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Abstract

The invention discloses a production process of mezlocillin sodium. The production process comprises the following steps: (1), cleaning, sterilizing and checking reaction equipment and a working place; (2), preparing a sodium bicarbonate suspension; (3), performing a salt forming reaction; (4), decoloring; (5), filtering and removing bacteria; (6), freeze-drying; (7), crushing; (8), packaging, wherein a salt forming reaction equation is described in the specification. According to the production process, in accordance with the provision of the new-edition Chinese pharmacopoeia, through improving a salt forming procedure and strictly controlling filtering, bacterium-removing, and freeze drying operations, the yield of drugs is increased; prepared mezlocillin sodium is low in content of polymer and impurities, and better in applicability and medicinal property.

Description

technical field [0001] The invention relates to the field of drug synthesis, in particular to a production process of mezlocillin sodium. Background technique [0002] Mezlocillin Sodium (Mezlocillin Sodium), its chemical name is (2S,5R,6R)-3,3-dimethyl-6-[(2R)-{3-(methylsulfonyl-2-oxo-1 -imidazolidinecarbonamide)-2-phenylacetamido}-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid sodium salt, its structural formula is [0003] [0004] The chemical formula is C 21 h 24 NaN 5 o 8 S 2 , with a molecular weight of 561.56, calculated as anhydrous matter, containing mezlocillin (C 21 h 25 N 5 o 8 S 2 ) should be 91.0%~97.8%. Mezlocillin sodium is white or off-white powder or crystal; odorless or slightly specific odor, bitter taste; hygroscopic. Mezlocillin sodium is a semi-synthetic penicillin antibiotic that is effective against Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Proteus, Enterobacter, Citrobacter, Serratia, Acinetobacter a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D499/68C07D499/16C07D499/18
CPCC07D499/68C07D499/16C07D499/18
Inventor 王多平
Owner JIANGSU HI STONE PHARMA
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