Moxifloxacin hydrochloride glucose injection and preparation method and use thereof

Abstract

The invention provides moxifloxacin hydrochloride glucose injection and a preparation method and use thereof. The method for preparing the injection comprises the following steps of: adding water for injection accounting for 20 to 98 percent of the batch volume into an ingredient tank, and adding glucose, a metal complexing agent and the moxifloxacin hydrochloride in a ratio; after stirring to fully dissolve the components, regulating the pH value to between 4.0 and 4.5 by using 1mol / L hydrochloric acid solution or 1mol / L sodium hydroxide, adding medicinal carbon accounting for 0.05 percent (W / V) of the total volume, uniformly stirring, maintaining the temperature of between 70 and 80 DEG C for 20 minutes, and performing circular filtering for over 20 minutes; replenishing the water for injection to the batch scale, stirring for 5 to 10 minutes, and detecting the pH value of the prepared solution (controlling to between 4.0 and 4.5); after determining that no residual water is present in an elevated tank and a pipeline, opening a valve of the elevated tank, and sampling liquid medicament at a self-circulation pipeline sampling port after the liquid medicament circulates for 20 minutes through a filter element and the elevated tank; detecting according to the intermediate quality standard, requiring that the content of the moxifloxacin hydrochloride is between 1.52 and 1.68 mg / ml, the glucose content is between 47.5 and 52.5 mg / ml, and the pH value is between 4.0 and 4.5; after the intermediate is detected to be qualified, beginning to fill; and conveying the filled semi-finished products into a sterilizing cabinet for sterilization, wherein the sterilization condition is to sterilize for 8 to 30 minutes at 121 DEG C through thermal pressure steam.

Description

Technical field: [0001] The invention relates to a preparation of an injection containing moxifloxacin hydrochloride as a main medicinal component, a preparation method and an application thereof. technical background: [0002] Fluoroquinolones are fully synthetic antibacterial drugs that have developed very rapidly in the past two decades. They mainly act on the helicase and topoisomerase of bacterial DNA. They have the characteristics of broad antibacterial spectrum, strong antibacterial effect, and high safety. It is widely used clinically to treat respiratory, urinary tract, skin and soft tissue, ENT, gynecology, tuberculosis and other infections caused by Gram-positive bacteria, negative bacteria, and anaerobic bacteria. According to the chemical structure, antibacterial effect and in vivo process of quinolones, they can be divided into first, second, third and fourth generations, among which the third generation drugs such as ciprofloxacin and levofloxacin have excelle...

AI Technical Summary

Problems solved by technology

[0008] Adding metal ion complexing agent to moxifloxacin hydrochloride glucose injection of the present invention effectively solves the problem of poor stability of moxifloxacin hydrochloride glucose preparation

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