清胰口服液微生物限度检查方法验证

目的建立清胰口服液微生物限度检查方法,确保检验结果的正确性和可信性。方法按中国药典方法对3个批号的清胰口服液进行微生物限度检查方法验证。结果采用平皿法进行清胰口服液细菌、霉菌及酵母菌计数方法验证时,金黄色葡萄球菌、黑曲霉的回收率<70%,改用培养基稀释法后菌回收率均>70%,符合药典要求;大肠埃希菌采用药典规定的方法未检出。结论常规法适用于清胰口服液大肠埃希菌、枯草芽孢杆菌、白色念珠菌的验证;培养基稀释法适用于金黄色葡萄球菌、黑曲霉的验证。

Methodology Validation Study of Microbial Limit Examination of Qingyi Oral Liquid

OBJECTIVE To establish a method of microbial limit examination of Qingyi oral liquid, ensuring the validity and creditability of results. METHODS According to the method of the 2010 Chinese Paharmacopoeia, microbial limit examination of three batches of Qingyi oral liquid were studied. RESULTS The recoveries of Staphylococcus aureus and Asperqillus niger using plate method were less than 70%, and they were more than 70% while using culture medium dilution method. Escherichia coli were not determined using the method of the Chinese Paharmacopoeia. CONCLUSION The plate method can be used in microbial limit examination of Escherichia coli, Bacillus subtilis and Candida albicans in Qingyi oral liquid, while the culture medium dilution method can be used in microbial limit examination of Staphylococcus aureus and Asperqillus niger.