Rifamycin sodium injection and preparation method thereof

Abstract

The invention discloses a preparation method of rifamycin sodium injection. In 1,000ml injection, the rifamycin sodium injection comprises the flowing components: 62.5g of rifamycin sodium counted by C37H47NO12, 7.5g of vitamin C, 4g of sodium metabisulfite, 170 ml of propanediol, 1g of medicinal carbon and the balance of water for injection. The preparation method comprises the following concrete steps of: (1) adding the propanediol into the water for injection, evenly stirring, introducing nitrogen, stirring, adding the vitamin C to completely dissolve and adjusting the pH value to 6.2-6.4; (2) adding the sodium metabisulfite for completely dissolving, then adding the rifamycin sodium raw materia, stirring to completely dissolve, adjusting the pH value to 7.2-7.2 and additionally adding the water for injection to full dose; (3) adding active carbon, introducing nitrogen under the condition of 50 DEG C, stirring for 10 minutes, standing, decarburizing and filtering, adjusting the pH value to 7.2-7.3 and sequentially filtering through filter elements with 0.45 micrometer and 0.22 micrometer; (4) after qualifying semi-finished products, filtering the qualifying semi-finished products by the filter element with 0.22 micrometer and introducing nitrogent for protection; and (5) filtering stock solution by the filter element with 0.22 micrometers, introducing nitrogen for encapsulation, sterilizing the solution by 100 DEG C flowing steam for 30 minutes, and carrying leak detection, lamp test, drying, lettering and packaging to finally obtain the rifamycin sodium injection.

Description

Technical field: [0001] The invention relates to an injection and a production method thereof, in particular to a formula of rifamycin sodium injection and a preparation method thereof, belonging to the field of biomedicine. Background technique: [0002] Rifamycin is a relatively new antibiotic isolated from the fermentation broth of Streptomyces by the Letti Institute in Italy. It has strong bactericidal effect and wide antibacterial spectrum. Bacteria, etc., as long as the drug concentration is very low in the in vivo test, it can have a strong bactericidal effect. The blood concentration is higher, and it is also effective against Gram-negative bacteria, and Mycobacterium tuberculosis is also highly sensitive to rifamycin. In addition, rifamycin has almost no cross-resistance reactions with other antibiotics. Its toxicity is very low, it has little effect on liver and kidney function, it will not cause vestibular and auditory dysfunction, and it has little gastrointest...

AI Technical Summary

Problems solved by technology

Due to the complex process and strong technicality of rifamycin sodium injection preparations, very few domestic manufacturers have formally produced them, which cannot meet clinical needs, and a large number of rifamycin sodium injections still need to be imported every year

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