Process for preparing piperacillin sodium by using solvent method

A piperacillin sodium, solvent method technology, applied in the direction of organic chemistry, etc., can solve the problems of complex operation, the moisture can not reach moisture ≤ 2.0%, expensive equipment, etc., to achieve the effect of simple operation, low equipment requirements, and low residues

Inactive Publication Date: 2013-03-20
JIANGXI FUSHINE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The freeze-drying method commonly used in domestic industrial production, but the operation is complex and the equipment is expensive, and the piperacillin sodium prepared by the solvent method reported in the literature, the moisture cannot reach the standard of ≤2.0% in CP2010

Method used

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  • Process for preparing piperacillin sodium by using solvent method
  • Process for preparing piperacillin sodium by using solvent method
  • Process for preparing piperacillin sodium by using solvent method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Dissolve 3.2g of sodium methoxide in 80ml of absolute ethanol; dissolve 30g of piperacillin in 1080ml of anhydrous acetone, lower the temperature to 0~5°C under the protection of helium, add the above sodium methoxide solution dropwise, control the temperature at 0~5°C, drop The addition time is about 2 hours, the dropwise addition is completed, the temperature is kept for 10 hours, the temperature is naturally returned to 15°C after stirring, the filter cake is pressure-filtered with helium, the filter cake is dried under reduced pressure at 65°C for 12 hours, and the material is discharged after being evacuated with helium gas. CP2010) piperacillin sodium 22.0g. Following is the detection result to the product that makes:

[0018]

Embodiment 2

[0020] Dissolve 3.2g of sodium methoxide in 80ml of absolute ethanol; dissolve 30g of piperacillin in 1080ml of anhydrous acetone, lower the temperature to 0~5°C under nitrogen protection, add the above sodium methoxide solution dropwise, control the temperature at 0~5°C, and add dropwise The time is about 2 hours, the dropwise addition is completed, keep warm for 10 hours, stir and naturally return to 15°C, nitrogen pressure filtration, filter cake is dried under reduced pressure at 65°C for 12 hours, and the material is discharged after being evacuated with nitrogen, and the obtained product conforms to the Chinese Pharmacopoeia (CP2010) Piperacillin Sodium 22.5g, purity spectrum see figure 1 , the content was 90.2% after comparison with the standard product of China National Institute for the Control of Pharmaceutical and Biological Products. Wherein A peak is ampicillin; B peak is impurity A; C peak is piperacillin sodium.

[0021]

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Abstract

The invention provides a process for preparing piperacillin sodium by using a solvent method. The process comprises the following steps of: dissolving sodium methoxide into an anhydrous organic solvent; dissolving piperacillin into anhydrous acetone, cooling to the temperature of between 0 and 5 DEG C under the protection of an inert gas, dripwise adding a sodium methoxide solution, controlling the temperature to be between 0 and 5 DEG C, naturally returning the temperature of between 12 and 18 DEG C with stirring after dripwise adding, and preserving heat until the reaction is ended; and performing filter pressing on the reacted product by adopting the inert gas, drying filter cakes at the temperature of between 60 and 70 DEG C under reduced pressure, emptying with the inert gas, discharging, and thus obtaining the piperacillin sodium in accordance with Chinese pharmacopeia (CP2010). The piperacillin sodium in accordance with the Chinese pharmacopeia (CP2010) can be prepared by the process, the preparation method is easier to operate, the equipment requirement is low, and the piperacillin sodium has the characteristics of high purity, high yield, high content and low residue.

Description

technical field [0001] The invention relates to a preparation method of piperacillin sodium. Background technique: [0002] The chemical name of piperacillin sodium is (2S, 5R, 6R)-6-[2-(2R)-4-(4-Base. Amino-2-phenylacetamido] sodium penicillate, developed by Toyama Chemical Industry Co., Ltd., Japan, is clinically applicable to the sepsis caused by sensitive Enterobacteriaceae bacteria, Pseudomonas aeruginosa, and Mycobacterium spp. Upper urinary tract and complicated urinary tract infection, respiratory tract infection, biliary tract infection, abdominal infection, pelvic infection, skin and soft tissue infection, etc., piperacillin sodium / sulbactam sodium combined, and piperacillin sodium / tazobactam The combination of sodium has good stability, and shows strong antibacterial activity against common clinical enzyme-producing bacteria, expanding the antibacterial spectrum, and is widely used in domestic and foreign markets. Freeze-drying is generally used in domestic indu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D499/68C07D499/16
Inventor 柴建华刘亚林许蓓珍
Owner JIANGXI FUSHINE PHARMA CO LTD
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