蓝山颗粒和蓝山口服液微生物限度检验方法的建立

Establishment of Microbial Limit Test for Lanshan Oral Solution(蓝山口服液) and Lanshan Granules(蓝山颗粒)

目的:建立医院制剂蓝山颗粒和蓝山口服液的微生物限度检验方法。方法:按照《中国药典》(2015版)四部通则微生物限度检查法的规定,采用平皿法对蓝山颗粒和蓝山口服液的微生物限度检验方法进行适用性试验。结果:所建立的检测方法对金黄色葡萄球菌、铜绿假单胞菌、枯草芽孢杆菌、白色念珠菌、黑曲霉5种验证菌株的回收率均为0.5~1.5,控制菌(大肠埃希菌)可检出,阴性对照组没有检出控制菌。结论:采用常规法对蓝山颗粒和蓝山口服液进行微生物限度检查,操作简单快速,结果准确可靠,可以客观地反映药物中微生物的污染状况,能有效控制蓝山颗粒和蓝山口服液的质量。

Objective: To establish the method of microbial limit test for Lanshan oral solution and Lanshan granules. Methods: Routine pour-plate method were used in the suitablility test refer to the microbial limit test method in Chinese Pharmacopoeia 2015 edition Part Ⅳ. Results: The recoveries of all kinds of strains in the tests of Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans and Aspergillus niger were 0.5-1.5. In the method validations, Escherichia coli was detected, while the negative control was no growth detected. Conclution: The microbial limit test for Lanshan oral solution and Lanshan granules is validated in this study. The method is quick, accurate and suitable for quality control for Lanshan oral solution and Lanshan granules to reflect medicine microbial contamination.