盐酸麻黄碱滴鼻液微生物限度检查的验证

Validation of microbial limit test method of Ephedrine hydrochloride nasal drops

目的建立盐酸麻黄碱滴鼻液的微生物限度检查法。方法根据《中国药典》2010版二部附录ⅪJ微生物限度检查法常规法进行验证试验。结果试验组的菌回收率均大于70%,控制菌常规法验证检出阳性菌,阴性菌未检出。结论盐酸麻黄碱滴鼻液无抑菌作用,可用常规法进行微生物限度检查。

OBJECTIVE To establish a method for the microbial limit test of Ephedrine hydrochloride nasal drops. METHODS A validation of microbial limit test method was conducted in accordance with routine method states in the Appendix of Chinese Pharmacopoeia（2010 edition）. RESULTS The recoverries of test organisms by routine method were more than 70 %, the test organisms were detected in the control bacteria test and were not detected in the negative control bacteria test. CONCLUSIVE The Ephedrine hydrochloride nasal drops have no inhibitory effect, and Conventional method can be used in microbial limit test.