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Special piperacillin sodium-tazobactam sodium ultra-fine powder preparation and preparation method thereof

A technology of tazobactam sodium and piperacillin sodium, applied in the field of medicine, can solve the problems of low purity of active ingredients, large side effects, etc., and achieve the effects of good chemical reactivity, less impurities, and reduced drug consumption

Inactive Publication Date: 2015-08-26
杭州长典老一元健康管理有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0008] Piperacillin sodium-tazobactam sodium compound injection is widely used at present, and a variety of methods for synthesizing piperacillin sodium-tazobactam sodium preparations have also been disclosed at home and abroad, but the piperacillin sodium-tazobactam sodium prepared by these methods Zobactam sodium preparations have problems such as low purity of active ingredients and large side effects caused by it

Method used

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  • Special piperacillin sodium-tazobactam sodium ultra-fine powder preparation and preparation method thereof
  • Special piperacillin sodium-tazobactam sodium ultra-fine powder preparation and preparation method thereof

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Embodiment 1

[0026] Dissolve the crude piperacillin sodium and tazobactam sodium in water respectively, respectively go through cross-linked sephadex column gel column chromatography, and use 75% ethanol solution as eluent to collect piperacillin The eluted fraction with 95% content of cillin sodium and tazobactam sodium; the obtained eluted fraction is subjected to reverse phase chromatography column chromatography with C4 as a filler, and 60% ethanol aqueous solution is used as an eluent to collect piperacillin respectively. Sodium and tazobactam sodium content of 99% elution fraction.

[0027] Then, 99% of the eluted components of the gained piperacillin sodium and tazobactam sodium were dried for 15 hours in a vacuum drying oven with a vacuum degree of 0.06 MPa at 50° C. to obtain high-purity piperacillin sodium and high-purity piperacillin sodium. Pure tazobactam sodium raw material, and mix high-purity piperacillin sodium and high-purity tazobactam sodium raw material in a ratio of 3...

Embodiment 2

[0031] Dissolve the crude piperacillin sodium and tazobactam sodium in water respectively, respectively go through cross-linked Sephadex column gel column chromatography, use 90% ethanol solution as eluent, collect piperacillin respectively The eluted fraction with 95% content of cillin sodium and tazobactam sodium; the obtained eluted fraction is subjected to reverse phase chromatography column chromatography with C4 as filler, and 75% ethanol aqueous solution is used as eluent to collect piperacillin respectively Sodium and tazobactam sodium content of 99% elution fraction.

[0032] Then, 99% of the eluted components of the gained piperacillin sodium and tazobactam sodium were dried for 15 hours in a vacuum drying oven with a vacuum degree of 0.06 MPa at 50° C. to obtain high-purity piperacillin sodium and high-purity piperacillin sodium. Pure tazobactam sodium raw material, and mix high-purity piperacillin sodium and high-purity tazobactam sodium raw material in a ratio of ...

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Abstract

The present invention discloses a special piperacillin sodium-tazobactam sodium ultra-fine powder preparation and a preparation method thereof. The preparation method comprises: respectively dissolving a piperacillin sodium crude product and a tazobactam sodium crude product in water, respectively carrying out gel column chromatography, and respectively collecting the elution fractions of piperacillin sodium and tazobactam sodium by using an alkyl alcohol aqueous solution as an eluant; carrying out chromatography on the obtained elution fractions through a reverse phase chromatography column, and respectively collecting the elution fractions of piperacillin sodium and tazobactam sodium; respectively drying 99% of the elution fractions of piperacillin sodium and tazobactam sodium by using a vacuum drying method to prepare the raw materials such as the high purity piperacillin sodium and the high purity tazobactam sodium; mixing the obtained high purity piperacillin sodium and the obtained high purity tazobactam sodium according to a weight ratio to obtain the high purity piperacillin sodium-tazobactam sodium mixing powder raw material; and carrying out jet crushing on the obtained piperacillin sodium-tazobactam sodium mixing powder raw material to obtain the ultra-fine powder, and carrying out freeze drying.

Description

technical field [0001] The invention provides a piperacillin sodium-tazobactam sodium special ultrafine powder preparation and a preparation method thereof, which belong to the technical field of medicine. Background technique [0002] Piperacillin Sodium-Tazobactam Sodium is a compound preparation composed of Piperacillin Sodium and Tazobactam Sodium. [0003] Piperacillin sodium, its chemical name is (2S,5R,6R)-3,3-dimethyl-6-[(4-ethyl-2,3-dioxo-1-piperazinecarboxamido) Phenylacetylamino]-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid sodium salt, English name Piperacillin Sodium, molecular formula is C 23 h 26 N 5 NaO 7 S, the molecular weight is 539.54, the chemical structure formula is as follows: [0004] [0005] Tazobactam sodium, the chemical name is [2S-(2a,3b,5a)]-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl Base)-4-thio-1-azabicyclo[3,2,0]heptane-2-carboxylate sodium 4,4-dioxide, the English name Tazobactam sodium, the molecular formula is C ...

Claims

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Application Information

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IPC IPC(8): A61K31/496A61K9/14A61K9/19A61P31/04A61K31/431
Inventor 傅苗青李凤生陈宇东姜林海
Owner 杭州长典老一元健康管理有限公司
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