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Method for producing piperacillin sodium tazobactam sodium compound injection

A technology of piperacillin sodium and tazobactam sodium, applied in the field of medicine, can solve the problems of low purity of active ingredients and large side effects, and achieve the effects of improving solubility, low cost and improving stability

Inactive Publication Date: 2010-06-02
海南华旗药业销售有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The currently used piperacillin sodium-tazobactam sodium compound preparation has problems such as low purity of active ingredients and large side effects caused by it.

Method used

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  • Method for producing piperacillin sodium tazobactam sodium compound injection
  • Method for producing piperacillin sodium tazobactam sodium compound injection
  • Method for producing piperacillin sodium tazobactam sodium compound injection

Examples

Experimental program
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Effect test

Embodiment 1

[0045]The piperacillin sodium raw material for injection is dissolved in water, and the resulting solution is subjected to gel chromatography. The packing of the chromatographic column used is Sephadex LH-20, which is eluted with 60%-95% ethanol solution, and the piperacillin sodium is collected The elution fraction with content not less than 90%. The resulting eluted fraction was chromatographed with BUCHI medium pressure preparative chromatography, and the filler of the reverse chromatography column used was C 18 Alkyl bonded phase silica gel. Elute with 60%-80% ethanol solution, collect the eluted fraction with piperacillin sodium content not less than 99%, recover the solvent, and freeze-dry to obtain high-purity piperacillin sodium raw material with a yield of 85.2%.

[0046] The raw material of tazobactam sodium for injection is dissolved in water, and the resulting solution is subjected to gel chromatography. The filler of the chromatographic column used is Sephadex LH...

Embodiment 2

[0049] The piperacillin sodium raw material for injection is dissolved in water, and the resulting solution is subjected to gel chromatography. The filler of the chromatographic column used is Sephadex LH-60, which is eluted with 60%-95% ethanol solution, and the piperacillin sodium is collected The elution fraction with content not less than 90%. The resulting eluted fraction was chromatographed with BUCHI medium pressure preparative chromatography, and the filler of the reverse chromatography column used was C 4 Alkyl bonded phase silica gel. Elute with 60%-80% ethanol solution, collect the eluted fraction with piperacillin sodium content not less than 99%, recover the solvent, and freeze-dry to obtain high-purity piperacillin sodium raw material with a yield of 81.0%.

[0050] Dissolve the raw material of tazobactam sodium for injection in water, and perform gel chromatography on the obtained solution. The filler of the chromatographic column used is Sephadex LH-60, and el...

Embodiment 3

[0053] The high-purity piperacillin sodium and tazobactam sodium raw materials prepared according to Example 1 were mixed in a weight ratio of 4:1, pulverized through a 100-mesh sieve, and packed under the condition of grade 100 in a sterile room to obtain final product Piperacillin sodium-tazobactam sodium compound powder injection, each unit powder injection contains 3.375g piperacillin sodium and tazobactam sodium.

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Abstract

The invention provides a method for preparing high-purity piperacillin or tazobactam sodium, and a preparation method of piperacillin-tazobactam sodium compound injection. The method includes the following steps: (1) dissolving piperacillin or tazobactam sodium for injection into the water to obtain solution, performing gel chromatography in a gel column, and collecting eluting fraction with piperacillin or tazobactam sodium content of no smaller than 90%; and (2) separating in a reversed column chromatography, collecting eluting fraction with piperacillin or tazobactam sodium content of no smaller than 99%, freezing, drying and obtaining the high-purity piperacillin or tazobactam sodium material.

Description

technical field [0001] The invention provides a method for preparing high-purity piperacillin sodium or tazobactam sodium, and also provides a production method of piperacillin sodium-tazobactam sodium compound injection, which belongs to the technical field of medicine. Background technique [0002] Piperacillin is a spectrum semi-synthetic penicillin antibiotic, which has been widely used in clinic. Due to the long-term use and improper use of piperacillin, the therapeutic effect of piperacillin is declining, which affects the application of piperacillin to a large extent. Tazobactam sodium is a lactamase inhibitor and belongs to the third-generation antibacterial potent synergist. Combining it with piperacillin or cefoperazone can enhance the efficacy and prolong the action time of the two. When tazobactam sodium is used in combination with piperacillin sodium, it produces a significant synergistic effect, and is widely used in the treatment of severe systemic and local ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D499/68C07D499/86A61K31/43A61K31/431A61P31/04
Inventor 邱民
Owner 海南华旗药业销售有限公司
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