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 large side effects and low purity of active ingredients, and achieve the effects of low cost, improved solubility and reduced production cost

Inactive Publication Date: 2008-09-17
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 ha

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
Comparison scheme
Effect test

Example Embodiment

[0044] Example 1

[0045]The raw material of piperacillin sodium for injection is dissolved in water, and the resulting solution is subjected to gel chromatography. The packing of the chromatography column used is Sephadex LH-20, and the elution is carried out with 60%-95% ethanol solution, and the piperacillin sodium is collected The elution fraction with a content of not less than 90%. The obtained elution fraction was chromatographed with BUCHI medium pressure preparative chromatograph, and the packing of the reverse chromatography column used was C 18 Alkyl bonded phase silica gel. Elute with 60%-80% ethanol solution, collect the eluted fractions 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 was dissolved in water, and the resulting solution was subjected to gel chromatography. The filler of the chr...

Example Embodiment

[0048] Example 2

[0049] The raw material of piperacillin sodium for injection was dissolved in water, and the resulting solution was subjected to gel chromatography. The packing of the chromatography column used was Sephadex LH-60, which was eluted with 60%-95% ethanol solution to collect piperacillin sodium The elution fraction with a content of not less than 90%. The obtained elution fraction was chromatographed with BUCHI medium pressure preparative chromatograph, and the packing of the reverse chromatography column used was C 4 Alkyl bonded phase silica gel. Elute with 60%-80% ethanol solution, collect the eluted fractions with piperacillin sodium content of 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] The raw material of tazobactam sodium for injection is dissolved in water, and the resulting solution is subjected to gel chromatography. The packing of the chromatography column u...

Example Embodiment

[0052] Example 3

[0053] The high-purity piperacillin sodium and tazobactam sodium raw materials prepared in Example 1 were mixed in a weight ratio of 4:1, crushed through a 100-mesh sieve, and packed in a sterile room under 100-level conditions to obtain Piperacillin sodium and tazobactam sodium compound powder injection, each unit of 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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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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