Metronidazole and sodium chloride injection as well as preparation method and application thereof

A technology of metronidazole sodium chloride and nidazole sodium chloride, which is applied in the direction of pharmaceutical formulas, medical preparations without active ingredients, medical preparations containing active ingredients, etc., can solve the problem of metronidazole sodium chloride injection Poor stability and other issues

Inactive Publication Date: 2019-03-08
江西润泽药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to provide metronidazole sodium chloride injection and its preparation method and application in order to overcome the poor stability of metronidazole sodium chloride injection existing in the prior art. Sodium injection has good stability

Method used

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  • Metronidazole and sodium chloride injection as well as preparation method and application thereof
  • Metronidazole and sodium chloride injection as well as preparation method and application thereof
  • Metronidazole and sodium chloride injection as well as preparation method and application thereof

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preparation example Construction

[0029] The second aspect of the present invention provides a kind of preparation method of metronidazole sodium chloride injection, and the method comprises the following steps:

[0030] (1) Dissolve metronidazole, citric acid and sodium dihydrogen phosphate in water for injection, then add activated carbon, filter and decarbonize after stirring, to obtain intermediate solution A;

[0031] (2) dissolving sodium chloride in water for injection, then adding activated carbon, stirring and filtering to decarbonize to obtain intermediate solution B;

[0032] (3) Mix the intermediate liquid A and intermediate liquid B, then add disodium hydrogen phosphate to adjust the pH value to 4.7-7.0, add activated carbon, heat and boil, cool and filter for decarbonization in sequence, and pack under sterile conditions potting,

[0033] Wherein, the feeding ratio of metronidazole, sodium chloride, citric acid, sodium dihydrogen phosphate, disodium hydrogen phosphate and water for injection is ...

Embodiment 1

[0050] (1) Add 20L of water for injection into the first concentrated tank, then add 250g of metronidazole (D90≤6.35μm), 37.5g of citric acid and 75g of sodium dihydrogen phosphate, then add activated carbon, stir for 15min, and use 0.22μm The microporous membrane is filtered and decarbonized to obtain the intermediate solution A;

[0051] (2) Add 20L of water for injection into the second concentrated preparation tank, then add 400g of sodium chloride, then add activated carbon, stir for 15min, and filter and decarbonize with a 0.22 μm microporous membrane to obtain intermediate solution B;

[0052] (3) Mix the intermediate liquid A and intermediate liquid B, and transfer to the dilute preparation tank, set the volume to 50 L with water for injection, then add 100 g of disodium hydrogen phosphate to adjust the pH value to 6.2, then add activated carbon, and stir for 15 min. And use a 0.22 μm microporous membrane to filter and decarbonize, and pack and seal under sterile condi...

Embodiment 2

[0054] (1) Add 20L of water for injection into the first concentrated tank, then add 250g of metronidazole (D90≤6.35μm), 50g of citric acid and 125g of sodium dihydrogen phosphate, then add activated carbon, stir for 15min, and use 0.22μm The microporous membrane is decarbonized by filtration to obtain the intermediate solution A;

[0055] (2) Add 20L of water for injection into the second concentrated tank, then add 450g of sodium chloride, then add activated carbon, stir for 15min, and use a 0.22μm microporous membrane to filter and decarbonize to obtain intermediate solution B;

[0056] (3) Mix the intermediate solution A and the intermediate solution B, and transfer to the dilute tank, set the volume to 50L with water for injection, then add 100g of disodium hydrogen phosphate to adjust the pH value to 4.7, then add activated carbon, stir for 15min, And use a 0.22 μm microporous membrane to filter and decarbonize, and pack and seal under sterile conditions.

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Abstract

The invention relates to the field of metronidazole medicaments, and discloses a metronidazole and sodium chloride injection as well as a preparation method and application thereof. Based on the totalweight of the injection, the metronidazole and sodium chloride injection is prepared from the following components in percentage by weight: (1) 0.2 to 0.9 percent of metronidazole, (2) 0.1 to 0.9 percent of sodium chloride, (3) 0.01 to 0.1 percent of citric acid, (4) 0.05 to 0.3 percent of sodium dihydrogen phosphate, (5) 0.1 to 2 percent of disodium hydrogen phosphate, and (6) 96 to 99 percent of water for injection. The metronidazole and sodium chloride injection provided by the invention has good stability.

Description

technical field [0001] The invention relates to the field of metronidazole medicine, in particular to metronidazole sodium chloride injection and its preparation method and application. Background technique [0002] Metronidazole has a strong antibacterial effect on most anaerobic bacteria, but has no effect on aerobic bacteria and facultative anaerobic bacteria. The antibacterial spectrum includes Bacteroides fragilis and other Bacteroides, Fusobacterium, Clostridium aerogenes Bacillus, Eubacterium, Veillonella, Peptococcus and Peptostreptococcus, etc., Actinomycetes, Lactobacillus, and Propionibacterium are resistant to this product. [0003] Metronidazole sodium chloride injection is mainly used for the treatment of anaerobic infection, but in the prior art, the stability of metronidazole sodium chloride injection needs to be improved. Contents of the invention [0004] The purpose of the present invention is to provide metronidazole sodium chloride injection and its p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/12A61K47/02A61K31/4164A61P31/04
CPCA61K9/0019A61K9/08A61K31/4164A61K47/02A61K47/12A61P31/04
Inventor 廖年生邹明明胡贤德眭荣春
Owner 江西润泽药业有限公司
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