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Preparation method of mezlocillin sodium and mezlocillin sodium for injection

A technology of mezlocillin sodium and mezlocillin acid, which is applied in the field of preparation of mezlocillin sodium, can solve problems such as reducing the polymer content of mezlocillin sodium products that have not yet been raised, and achieve the possibility of reducing, reducing allergies, The effect of improving product quality

Active Publication Date: 2011-08-24
SUZHOU ERYE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method with the main purpose of reducing the polymer content of the mezlocillin sodium product has not been proposed in the art

Method used

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  • Preparation method of mezlocillin sodium and mezlocillin sodium for injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1 - the preparation of mezlocillin acid.

[0036] 1. Condensation reaction.

[0037] 1.1 Dissolution. Add 700L of purified water into the reaction kettle, start the stirring, put the cooling medium into the jacket of the kettle, cool down the purified water in the kettle to 2°C steadily, add 50kg of ampicillin acid trihydrate (quality control standard: Chinese Pharmacopoeia 2005) to the reaction After mixing the ampicillin acid trihydrate and water evenly, add 10% w / w sodium bicarbonate solution dropwise until the reaction solution is dissolved and clarified.

[0038] 1.2 Condensation. After ampicillin acid trihydrate was dissolved and clarified, 33kg of 1-chloroformyl-3-methylsulfonyl-2-imidazolidinone was added in batches for condensation reaction, and the reaction process was added dropwise with 10%w / w sodium bicarbonate solution, The pH of the reaction solution is controlled at 8.0-8.2, the temperature is controlled at 5±2° C., and the stirring speed i...

Embodiment 2

[0047] Embodiment 2---the preparation of mezlocillin sodium.

[0048] Add mezlocillin acid to water for injection, the weight ratio of mezlocillin acid to water for injection is 1:2.8, and the feed liquid is cooled to 12~15°C. Add 14%w / w NaHCO dropwise 3 Adjust the pH to 5.8, stir until the feed liquid is clear and the pH is stable, raise the temperature of the feed liquid to 20°C±2°C, stir for 30-60 minutes, add 2% of the weight of mezlocillin acid activated carbon for needles, stir for 15-30 Minutes later, decarbonize through a plate and frame filter. The filtrate after decarbonization is passed through 0.45 μm and 0.22 μm filters, sterilized and filtered to a 10,000-class clean area, and packed into a freeze-drying box under a 100-class laminar flow.

Embodiment 3

[0049] Embodiment 3---the preparation of mezlocillin sodium.

[0050] Add mezlocillin acid to water for injection, the weight ratio of mezlocillin acid to water for injection is 1:3.5, and the feed liquid is cooled to 12~15°C. Add 14%w / w NaHCO dropwise 3Adjust the pH to 6.5, stir until the feed liquid is clear and the pH is stable, raise the temperature of the feed liquid to 20°C±2°C, stir for 30-60 minutes, add 4% of the weight of mezlocillin acid activated carbon for needles, stir for 15-30 Minutes later, decarbonize through a plate and frame filter. The filtrate after decarbonization is passed through 0.45 μm and 0.22 μm filters, sterilized and filtered to a 10,000-class clean area, and packed into a freeze-drying box under a 100-class laminar flow.

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Abstract

The invention provides a preparation method of mezlocillin sodium and mezlocillin sodium for injection. The preparation method comprises the following steps of: (a) adding mezlocillin acid into water for injection, and cooling material liquor at 12-15 DEG C; (b) dropwise adding a NaHCO3 solution, adjusting the pH value at 5.8-6.5, and stirring until the material liquor is clean and the pH value is stable; (c) raising the temperature of the material liquor to be 20 DGE C+ / -2 DEG C, and stirring for 30-60 minutes; (d) adding active carbon for injections, stirring for 15-30 minutes, and decarburizing by a plate frame filter; (e) degerming and filtering the decarburized filtrate by a 0.45mu m filter and a 0.22mu m filter; and (f) freeze-drying to obtain the mezlocillin sodium finished product. By improving the conventional freeze-drying technology and combining with the improved preparation method of the mezlocillin acid, the method prepares the mezlocillin sodium product with low polymer content, so that the product quality is obviously improved, and the possibility of allergy caused by the product is greatly reduced.

Description

technical field [0001] The invention belongs to the field of drug synthesis, and relates to a preparation method of mezlocillin sodium, more specifically, to a preparation method of mezlocillin sodium with low polymer content. Background technique [0002] The chemical name of mezlocillin sodium is (2S, 5R, 6R)-3,3-dimethyl-6-[(R)-2[3-(methylsulfonyl)-2-oxo- 1-imidazolidinecarboxamido]-2-phenylacetamido]-7-oxo-4-thia-1-azabicyclo[3.2.O]-heptane-2-carboxylic acid sodium salt, is a semi-synthetic Penicillin antibiotics, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Proteus, Enterobacter, Citrobacter, Serratia, Acinetobacter, and penicillin-sensitive Gram-positive cocci It has antibacterial effect. [0003] The preparation method of mezlocillin sodium mainly contains reaction crystallization method and freeze-drying method at present. [0004] In the reaction crystallization method, mezlocillin acid is added to ethyl acetate for acidification treatment, th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D499/16C07D499/04
Inventor 陈学文朱炜徐立伽陆文娟
Owner SUZHOU ERYE PHARMA CO LTD
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