注射用盐酸万古霉素的无菌实验方法学研究

Study on Methodology of Sterility Test of Vancomycin Hydrochloride for Injection

目的:建立注射用盐酸万古霉素无菌检查的方法。方法:选用不同溶剂、稀释剂及冲洗量,用薄膜过滤法对注射用盐酸万古霉素进行无菌检查。结果:以灭菌水为溶剂,以pH7.0氯化钠-蛋白胨缓冲液为冲洗剂,冲洗量为500mL的方法可获满意结果。结论:该方法灵敏,结果准确,可作为注射用盐酸万古霉素无菌检查的方法。

Objectives：To establish the method of sterility test of Vancomyein Hydrochlofide for Injection. Methods： With different solvent, diluent and flushing dose, the membrane filteration was used in the sterility test of Vancomycin Hydrochlofide for Injection. Results： It could obtain satisfied results by using sterile water dissolving sample, pH7.0 sodium chloride peptone buffer solution and flushing dose 500ml. Conclusions： This method is sensitive and accurate, and applicable for sterility test of Vancomycin Hydrochloride for Injection.