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Method for producing high-purity mezlocillin sodium and powder injection thereof

A technology of mezlocillin sodium powder and mezlocillin sodium, which is applied in the field of medicine, can solve the problems of poor stability, poor clarity, and low purity, and achieve the effects of improving stability, improving purity, and improving clarity

Inactive Publication Date: 2010-06-30
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

Most mezlocillin sodium raw materials have the problems of low purity, poor clarity after dissolution, and poor stability in aqueous solution, which is also a common problem of all antibiotic drugs

Method used

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  • Method for producing high-purity mezlocillin sodium and powder injection thereof
  • Method for producing high-purity mezlocillin sodium and powder injection thereof
  • Method for producing high-purity mezlocillin sodium and powder injection thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0050] Stir and dissolve mezlocillin acid in purified water, add 2 mol / L sodium hydroxide solution to adjust the pH of the solution to 8.7, then adsorb it with D1300 macroporous resin, and elute it with distilled water until there is almost no mezlocillin sodium in the eluent. Collect the eluate, concentrate the eluate by evaporation under reduced pressure, and use SephadexC 15 Carry out column chromatography on a cross-linked Sephadex column as a filler, elute with 0.05mol / L ammonium formate aqueous solution, the elution temperature is 15°C, collect the part with an integral area ratio of 99% or more detected by HPLC, and add a solution volume of 0.2 % (g / ml) activated carbon, decolorized at room temperature for 30 minutes, sterilized by filtration with a 0.22um microporous membrane, and freeze-dried to obtain mezlocillin sodium with a purity of 99.5% and a yield of 87.8%.

[0051] After the above-mentioned mezlocillin sodium pure product is freeze-dried, crushed through a 60...

Embodiment 2

[0053] Stir and dissolve mezlocillin acid in purified water, add 10% sodium carbonate solution to adjust the pH of the solution to 9.0, adsorb with D1300 macroporous resin, and elute with distilled water until there is almost no mezlocillin sodium in the eluent. Collect the eluate, concentrate the eluate by evaporation under reduced pressure, and use SephadexC 25 Carry out column chromatography on a cross-linked Sephadex column as a filler, elute with 0.1mol / L ammonium acetate aqueous solution, and the elution temperature is 20°C, collect the part with an integral area ratio of 99% or more detected by HPLC, and add a solution volume of 0.2 % (g / ml) activated carbon, decolorized at room temperature for 30 minutes, sterilized by filtration with a 0.22um microporous membrane, and freeze-dried to obtain mezlocillin sodium with a purity of 99.6% and a yield of 88.2%.

[0054] After the above-mentioned mezlocillin sodium pure product is freeze-dried, pulverize through a 100-mesh sie...

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Abstract

The invention provides a method for preparing high-purity Mezlocillin sodium, and a method for preparing Mezlocillin sodium powder for injection. The method includes the following steps: (1) absorbing Mezlocillin sodium or Mezlocillin sodium made from Mezlocillin acid crude drug and alkaline sodium salt with macroporous resin, eluting with purified water, and collecting the eluent; (2) purifying the primary pure product with a gel column, eluting with salt solution having certain concentration to obtain refined product with the Mezlocillin sodium content of greater than 99%, decoloring with activated carbon, filtering with 0.22 Mum microporous filter membrane, sterilizing, freeze drying to obtain the high-purity Mezlocillin sodium, pulverizing, and sterile packaging to obtain Mezlocillin sodium powder for injection.

Description

technical field [0001] The invention relates to a method for preparing high-purity mezlocillin sodium, and also relates to a method for preparing mezlocillin sodium powder injection, which belongs to the technical field of medicine. Background technique: [0002] Mezlocillin sodium is a semi-synthetic penicillin antibiotic, which is effective against Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Proteus, Enterobacter, Citrobacter, Serratia, Acinetobacter and penicillin Sensitive Gram-positive cocci have antibacterial effect, and large doses have bactericidal effect. The antibacterial activity against Escherichia coli, Enterobacter, Klebsiella pneumoniae, Citrobacter, Serratia, and Acinetobacter is stronger than that of carbenicillin and ampicillin; against indole-positive Proteus, Pseudomonas aeruginosa The antibacterial activity against gram-positive bacteria such as Staphylococcus aureus is similar to that of carbenicillin, while the antibacterial activ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D499/68A61K9/14A61K31/431A61P31/04
Inventor 邱民
Owner 海南华旗药业销售有限公司
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