盐酸莫西沙星氯化钠注射液无菌检查验证方法研究

目的:通过三家不同企业生产的盐酸莫西沙星氯化钠注射液无菌检查方法研究,建立合适的方法为该药品的无菌检查方法。方法:采用薄膜过滤-中和剂法,通过无菌验证试验确定所用无菌检查方法的有效性。结果:建立了该品种的无菌检查方法为薄膜过滤-中和剂法。结论:通过验证试验,确保该药品无菌检查方法的可行,并保证结果可靠,对其他厂家生产的盐酸莫西沙星氯化钠注射液的无菌检查提供依据。

Objective: Discuss about different Sterility Texts of Moxifloxacin Hydrochloride and Sodium Chloride injection used in three factories and find out an appropriate one; Method: Confirm the availability of these sterility tests through confirmatory experiments of using membrane-filter neutralizer procedure. Result: All these three vendors choose the membrane-filter neutralizer procedure(PH7.0 Sodium Chloride Peptone as buffer solution for the Thioglycollate fluid medium tube, flush dose: 1000ml/tube, 100ml/treatment, at the same time add 2mol/L Mg SO4 Solution 2ml in the tube; make an improvement in unflushing Matin Medium tube) to process the test. Conclusion: The membrane-filter neutralizer procedure is availability and the result is believable as the confirmatory experiments showed. At the same time, this could be basis for sterility tests of Moxifloxacin Hydrochloride and Sodium Chloride injection when the other vendors need.