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Rifampicin medicine and preparing method

A technology of rifampicin and drugs, applied in the field of drugs for the treatment of pulmonary tuberculosis and other tuberculosis, to achieve the effects of saving medical expenses, convenient use, and quick onset of action

Active Publication Date: 2006-03-08
沈阳双鼎制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above properties make it difficult to make rifampicin into injection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] The preparation method of rifampicin injection is to get rifampicin 300g, slowly add in 1000ml mixed solution under stirring, this mixed solution is made of 0.85% anhydrous sodium sulfite, 0.04% disodium edetate and 99.11 % Propylene Glycol Mixed Formulated. Stir for 10 minutes, slowly add 5% NaOH dropwise under stirring, adjust the pH to 7.0, add activated carbon for needles according to 0.15% of the solution volume, stir for 10 minutes, filter to remove carbon, pass through a 0.2um microporous filter membrane, and then use propylene glycol solvent Set the volume to 5000ml, measure the content in the range of 90.0-115.0%, fill it into a glass ampoule, fill it with nitrogen, and seal it; circulate steam at 100°C, sterilize for 30 minutes, cool down, inspect, pack, and get ready.

Embodiment 2

[0020] The preparation method of rifampicin injection is to get rifampicin 300g, slowly add in the 1000ml mixed solution under stirring, this mixed solution is made of 1.15% anhydrous sodium sulfite, 0.03% disodium edetate and 98.82 % Propylene Glycol Mixed Formulated. Stir for 10 minutes, slowly add 5% NaOH dropwise under stirring, adjust the pH to 8.0, add activated carbon for needles according to 0.13% of the solution volume, stir for 10 minutes, filter to remove carbon, pass through a 0.2um microporous filter membrane, and then use propylene glycol solvent Set the volume to 5000ml, measure the content in the range of 90.0-115.0%, fill it into a glass ampoule, fill it with nitrogen, and seal it; circulate steam at 100°C, sterilize for 30 minutes, cool down, inspect, pack, and get ready.

Embodiment 3

[0022] The preparation method of rifampicin injection is to get rifampicin 300g, slowly add in the 1000ml mixed solution under stirring, this mixed solution is made of 1.05% anhydrous sodium sulfite, 0.02% edetate disodium and 98.93 % Propylene Glycol Mixed Formulated. Stir for 10 minutes, slowly add 15% NaOH dropwise under stirring, adjust the pH to 8.5, add activated carbon for needles according to 0.19% of the solution volume, stir for 10 minutes, filter to remove carbon, pass through a 0.2um microporous filter membrane, and then use propylene glycol solvent Set the volume to 5000ml, measure the content in the range of 90.0-115.0%, fill it into a glass ampoule, fill it with nitrogen, seal it; circulate steam at 100°C for 30 minutes, cool it, test it, pack it, and get it.

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PUM

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Abstract

The preparation method of rifampicin injection includes the following steps: slowly adding 300g of rifampicin into 1000ml of mixed solution under the condition of continuously stirring, said mixed solution is made up by mixing (by volume ratio) 0.75-1.2% of chemical inhibitor anhydrous sodium sulfite, 0.01-0.05% of metal ion complexing agent disodium ethylene diamine tetraacetate and 98.75-99.2% of organic solvent propylene alcohol, stirring them for 10-20 min, slowly drop-adding 5% NaOH under the condition of stirring, regulating pH to 6.5-9.0, adding active carbon for injection, stirring for 10 min, filtering to remove carbon, filtering by means of microporous filtering film, making constant volume to 5000ml, filling into glass ampule, charging nitrogen gas, sealing, sterilizing for 30 min by means of flowing steam with 100deg,C. cooling, checking and packaging.

Description

(1) Technical field [0001] The invention relates to a medicine for treating pulmonary tuberculosis and other tuberculosis, in particular to a rifampicin medicine whose dosage form is an injection. (2) Background technology [0002] Rifampicin has antimicrobial activity against a variety of pathogenic microorganisms, and the drug has obvious bactericidal effects on Mycobacterium tuberculosis and some non-tuberculous mycobacteria (including Mycobacterium leprae, etc.) inside and outside the host cell; Aerobic Gram-positive bacteria have good antibacterial effect, including Staphylococcus enzyme-producing strains and methicillin-resistant strains, Streptococcus pneumoniae, other Streptococcus species, Enterococcus species, Listeria species, Bacillus anthracis, perfringens bacillus, diphtheria bacillus, anaerobic cocci, etc.; it also has high antibacterial activity against aerobic gram-negative bacteria such as Neisseria meningitidis, Haemophilus influenzae, and Neisseria gonorr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4965A61K9/08A61P31/06
Inventor 王东凯马占之李志强李翔詹君
Owner 沈阳双鼎制药有限公司
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