复方甘草口服溶液微生物限度检查法验证实验

Validation of microbial limit test method of Compound Glycyrrhiza Oral Solution

目的:建立复方甘草口服溶液的微生物限度检查法。方法:根据《中国药典》2005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:复方甘草口服溶液微生物限度检查法符合《中国药典》的验证规定。

Objective： To establish a method for the microbial limit test of Compound Glycyrrhiza Oral Solution.Methods： A validation of microbial limit test method was conducted in accordance with routine method stated in the Appendix of Chinese Pharmacopoeia（2005 edition）.Results：The recoveries 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. Conclusion：The method for the microbial limit test of Compound Glycyrrhiza Oral Solution was validated.