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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: To study the aseptic method of moxifloxacin hydrochloride sodium chloride injection produced by three different enterprises and to establish a suitable method for the sterility test of the drug. METHODS: The effectiveness of the sterility test was determined by aseptic validation tests using a membrane filtration-neutralizer method. Results: The sterile test method for this variety was established as membrane filtration-neutralizer method. Conclusion: Through the verification test, to ensure that the method of sterility of the drug is feasible and reliable, and provide the basis for the sterility test of moxifloxacin hydrochloride sodium chloride injection produced by other manufacturers.