摘要
目的建立注射用丹参多酚酸盐的无菌检查方法,并对方法进行验证。方法按《中国药典》2010年版一部附录ⅩⅢB无菌检查法进行方法学验证。结果用0.1%蛋白胨水溶液作稀释剂进行稀释,采用薄膜过滤法进行过滤,加相应的培养基进行培养,六种试验菌供试品阳性对照(PPC)与阳性对照(PC)比较均生长良好,符合验证要求。结论验证所建立的方法可用于注射用丹参多酚酸盐的无菌检查,结果准确、可靠。
Objective TO establish and validate a method for sterility test of depsides salts from salvia miltiorrhiza for injection. Methods Perform methodology validation for sterility test according to Appendix ⅩⅢB,Chinese Pharmacopeia（ Edition 2010 VolⅠ）. Results The drug is diluted by 0. 1% peptone solution,filtered by membrane filtration,and cultured with nutrient medium. All six testing strains compared product positive control with positive control grow well,the method could meet the requirement of the validation. Conclusion This method can be used for sterility test of depsides salts from salvia miltiorrhiza for injection. The testing results are accurate and reliable.
出处
《安徽医药》
CAS
2014年第2期250-254,共5页
Anhui Medical and Pharmaceutical Journal
关键词
注射用丹参多酚酸盐
无菌检查
方法学验证
depsides salts from salvia miltiorrhiza for injection
sterility test
methodology validation
