Preparation process of moxifloxacin hydrochloride sodium chloride injection

Abstract

The invention aims at providing a preparation process of a moxifloxacin sodium chloride injection with better quality, good stability and small side effect. The preparation method of the moxifloxacin hydrochloride injection provided by the invention comprises the following steps: step 1, weighing: respectively weighing moxifloxacin hydrochloride and sodium chloride by formula dosage and preparing for later use; step 2: preparing a solution (1): taking water for injection, adding moxifloxacin hydrochloride, stirring until full dissolution, adding medicinal carbon, homogenizing, stirring for absorption, removing carbon and filtering by a filter membrane, washing the carbon layer with a proper amount of water for injection and reserving the filtrate for later use; step 3: preparing a solution (2): taking water for injection, adding full dose of sodium chloride by formula dosage, stirring until full dissolution, cooling, adding medicinal carbon, homogenizing, stirring for absorption, removing carbon and filtering by a filter membrane, then washing the carbon layer with water for injection, combining the filtrates, adding water for injection to full dose, regulating the pH value and homogenizing for later filling; and step 4: filling: filtering by a microporous filter membrane for liquid medicine, filling the filtrate into glass infusion bottles, charging nitrogen, plugging and capping for later sterilization.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a novel moxifloxacin hydrochloride sodium chloride injection and a preparation method thereof. Background technique [0002] Moxifloxacin hydrochloride is a new broad-spectrum high-efficiency fourth-generation fluoroquinolone antibacterial drug. In 2005, Moxifloxacin hydrochloride sodium chloride injection was launched in China with the trade name: Baifule. From the perspective of chemical structure, the 7th substituent group of moxifloxacin is a diazabicycle, which can reduce drug resistance caused by active efflux of microorganisms (the main mechanism of cross-resistance to quinolones), and ensure its drug resistance Low advantage, the introduction of a methoxy group at the 8th position enables this product to enhance the antibacterial activity against Gram-positive bacteria, atypical pathogenic bacteria and anaerobic bacteria while retaining the original ...

AI Technical Summary

Problems solved by technology

This is poor in control operability in industrial production, and the production cost is high

[0007] On the other hand, world patent WO2007037330, Chinese patent application 2004100533214, Chinese patent application 200510093595.0, and Chinese patent application 200510092828.5 disclose freeze-dried preparations containing moxifloxacin or quinolones, but those skilled in the art can easily understand that freeze-dried preparations cannot Autoclave sterilization has a lower level of sterility assurance compared to injections, higher production costs, and needs to be reconstituted with a solvent before use, which is inconvenient to use

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