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Method for improving yield of injection piperacillin sodium and tazobactam sodium

A technology of piperacillin sodium and tazobactam sodium, which is applied in the field of medicine, can solve the problems of reducing product yield, affecting the speed of reaction, and degradation of main components, so as to achieve the effect of improving stability and ensuring quality

Inactive Publication Date: 2014-10-08
JIANGSU HAIHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

2. The mixing method of the batching device should be reasonable, and the added Na + Quickly disperse and react with raw material acid to form a salt, which may cause local Na + If the concentration is too high, the main component will be degraded and the product yield will be affected
3. The temperature control of the batching reaction process will also affect the product yield. If the temperature is too low, it will affect the reaction speed. If the temperature is too high, the main components will be degraded and the product yield will be reduced.

Method used

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Embodiment Construction

[0009] The method for improving the yield of piperacillin sodium and tazobactam sodium for injection comprises the following steps:

[0010] 1. The weight ratio of piperacillinate sodium to tazobactam sodium is 2:1;

[0011] 2. Take the weight ratio of ion exchange resin and water as 1:30, mix with piperacillin acid and sodium tazobactam together or separately, adopt double cutting type, and the angle is 15 degrees between the blade and the liquid surface Angle, the stirring speed is 1300-1500 rpm, and the reaction speed is controlled at 80-90°C. Filter through a 120-mesh filter, and then prepare the filtrate into aqueous injections, infusions, powder injections or freeze-dried powder injections according to the conventional requirements of pharmacy.

[0012] In the present invention, the concentration of the main components piperacillin acid and tazobactam acid in the batching process not only affects the speed of the salt-forming reaction but also affects the yield of the f...

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Abstract

The invention provides a method for improving the yield of injection piperacillin sodium and tazobactam sodium. The method is characterized by comprising the following steps: (1) weighing piperacillin sodium and tazobactam sodium in a weight ratio of 2:1; (2) weighing ionic exchange resin and water in a weight ratio of 1:30, jointly or independently mixing with piperacillin sodium and tazobactam sodium, stirring at a speed of 1300-1500 revolutions / minute by adopting a double-section paddle type at an angle of 15 degrees formed by leading a paddle to be vertical to the liquid level, filtering by use of a 120-mesh filter screen, and preparing injections, infusion solutions, powder injections or lyophilized powder. According to the method, the yield of the injection piperacillin sodium and tazobactam sodium is 90.0 percent, the pH value is 6.3, the moisture is less than 0.7 percent, the content of piperacillin in 1mg of injection piperacillin sodium and tazobactam sodium is 882 mu g, and the content of tazobactam in 1mg of injection piperacillin sodium and tazobactam sodium is 112 mu g, so that the drug stability is further improved, and the quality of medicines in validity can be guaranteed.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for increasing the yield of piperacillin sodium and tazobactam sodium for injection. Background technique [0002] Piperacillin / tazobactam is a compound broad-spectrum antibiotic composed of piperacillin sodium and β-lactamase inhibitor tazobactam sodium. Piperacillin is a semi-synthetic broad-spectrum penicillin belonging to the ureide penicillin family. Its antibacterial mechanism is similar to that of penicillin. It plays an antibacterial effect by binding to the main penicillin-binding proteins (PBPs) of bacteria and interfering with the synthesis of bacterial cell walls. It is characterized by a broad spectrum, but not resistant to penicillinase. Tazobactam, also known as triazinemethyl penicillin sulfone, is a penicillin acid sulfone and an inhibitor of β-lactamase. It has almost no antibacterial activity itself, but has a strong broad-spectrum inhibitory effec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61P31/04A61K31/431
Inventor 李汉荣许前辉
Owner JIANGSU HAIHONG PHARMA
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