盐酸阿扑吗啡鼻喷剂微生物限度检查方法的验证

Apomorphine hydrochloride nasal spray validation method for microbial limit tests

目的建立盐酸阿扑吗啡鼻喷剂微生物限度检查方法,所检测的样品及检验程序不得对可能存在的各类微生物产生抑制作用。方法《中国药典》2010年版二部附录收载的微生物限度检查法中的薄膜过滤法进行实验。结果薄膜过滤法试验中稀释剂对照组的菌回收率和试验组的菌回收率均大于70%,微生物没有抑制作用。结论微生物限度检查方法可以采用薄膜过滤法。

Objective Establishment of apomorphine hydrochloride nasal spray method in microbial limit tests, the detected samples and inspection procedures shall not may exist to produce various types of micro- organisms inhibition. Methods ＂Chinese Pharmacopoeia＂ 2010 edition two appendix contained in microbial limit test of membrane filtration method experiment. Results Membrane filtration test diluent control group and experimental group of bacteria recycling rate of recycling rates are greater than 70% , no inhibition of microor- ganisms. Conclusion Microbial limit test method using membrane filtration method.