Piperacillin sodium and tazobactam sodium pharmaceutical composition and preparation method thereof

A technology of tazobactam sodium and piperacillin sodium, which is applied in the field of medicine, can solve the problems of poor stability of piperacillin sodium content, no crystallization and degradation products, etc., and achieve satisfactory clarity, rapid drying, and easy control Effect

Active Publication Date: 2014-02-05
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In view of the above problems, the present invention discloses a pharmaceutical composition of piperacillin sodium and tazobactam sodium and a preparation method thereof. By introducing a buffer pair to adjust the pH value, not only the problem of poor stability of the content of piperacillin sodium in the pharmaceutical composition is solved problem, and the generation of carbon dioxide gas is also avoided. The obtained powder injection dissolves quickly after being diluted by conventional infusion, and does not produce crystals and degradation products. The clarity of the solution meets the requirements, the pH of the solution does not change significantly, and the content of piperacillin sodium is stable.

Method used

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  • Piperacillin sodium and tazobactam sodium pharmaceutical composition and preparation method thereof
  • Piperacillin sodium and tazobactam sodium pharmaceutical composition and preparation method thereof
  • Piperacillin sodium and tazobactam sodium pharmaceutical composition and preparation method thereof

Examples

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Effect test

Embodiment 1

[0023] A pharmaceutical composition of piperacillin sodium and tazobactam sodium, comprising piperacillin sodium and tazobactam sodium, and also comprising disodium hydrogen phosphate-sodium dihydrogen phosphate buffer pair, and its specific preparation steps are as follows:

[0024] (A) accurately weigh 100g piperacillin sodium and 25g tazobactam sodium, join in 1000ml of water for injection, fully stir;

[0025] (B) Add disodium hydrogen phosphate-sodium dihydrogen phosphate buffered solution with a concentration of 0.2M and a pH of 5.8 dropwise under stirring until the pH value is adjusted to 5.0, continue stirring for 30 minutes after the addition is completed, and sterilize and filter;

[0026] (C) The solution obtained in (B) was spray-dried, aseptically pulverized, and aseptically distributed to obtain 100 bottles of piperacillin sodium-tazobactam sodium powder injection preparation.

Embodiment 2

[0028] A pharmaceutical composition of piperacillin sodium and tazobactam sodium, comprising piperacillin sodium and tazobactam sodium, and also comprising disodium hydrogen phosphate-sodium dihydrogen phosphate buffer pair, and its specific preparation steps are as follows:

[0029] (A) accurately weigh 100g piperacillin sodium and 25g tazobactam sodium, join in 1000ml of water for injection, fully stir;

[0030] (B) Add dropwise a disodium hydrogen phosphate-sodium dihydrogen phosphate buffer solution with a concentration of 0.2M and a pH of 6.5 under stirring until the pH value is adjusted to 6.0. After the addition is completed, continue to stir for 30 minutes, and then sterilize and filter;

[0031] (C) The solution obtained in (B) was spray-dried, aseptically pulverized, and aseptically distributed to obtain 100 bottles of piperacillin sodium-tazobactam sodium powder injection preparation.

Embodiment 3

[0033] A pharmaceutical composition of piperacillin sodium and tazobactam sodium, comprising piperacillin sodium and tazobactam sodium, and also comprising disodium hydrogen phosphate-sodium dihydrogen phosphate buffer pair, and its specific preparation steps are as follows:

[0034] (A) accurately weigh 100g piperacillin sodium and 25g tazobactam sodium, join in 1000ml of water for injection, fully stir;

[0035] (B) Add disodium hydrogen phosphate-sodium dihydrogen phosphate buffered solution with a concentration of 0.2M and a pH of 6.0 dropwise under stirring until the pH value is adjusted to 5.5, continue stirring for 30 minutes after the addition is completed, and sterilize and filter;

[0036] (C) The solution obtained in (B) was spray-dried, aseptically pulverized, and aseptically distributed to obtain 100 bottles of piperacillin sodium-tazobactam sodium powder injection preparation.

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Abstract

The invention discloses a piperacillin sodium and tazobactam sodium pharmaceutical composition and a preparation method thereof. The pharmaceutical composition mainly comprises piperacillin sodium and tazobactam sodium, as well as a disodium hydrogen phosphate-sodium dihydrogen phosphate buffer pair, and the powder injection is prepared by spraying and drying. The disodium hydrogen phosphate-sodium dihydrogen phosphate buffer pair is adopted for playing a role in buffering the pH of a solution, thus ensuring the content stability of piperacillin sodium, and no generation of carbon dioxide; the preparation technology is simple, convenient to control, fast to dry, and applicable to continuous large-scale production. The piperacillin sodium and tazobactam sodium powder injection is fast to dissolve, stable in quality, free from crystallization and degradation products, and the solution clarity meets the specification.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a pharmaceutical composition and a preparation method thereof, in particular to a pharmaceutical composition of piperacillin sodium and tazobactam sodium and a preparation method thereof. Background technique [0002] Piperacillin is a semi-synthetic penicillin antibiotic with broad-spectrum antibacterial activity and is widely used in clinical practice. However, it is hygroscopic, unstable in solution at room temperature, and easily forms particulate matter. Piperacillin is easily destroyed by β-lactamase, and tazobactam sodium is an irreversible competitive β-lactamase inhibitor, which belongs to the third generation antibacterial strong synergist. It has almost no antibacterial activity itself, but has Potent, broad-spectrum enzyme inhibitory effect, combined with piperacillin or cefoperazone can enhance the efficacy of the two and prolong the action time. When piperacillin so...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61K9/14A61K47/02A61P31/04A61K31/431
Inventor 张颖许美玲杨延昆朱玉正曲延伟刘鹏
Owner REYOUNG PHARMA
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