金柴胶囊微生物限度检查方法的建立和验证

摘要

目的：建立金柴胶囊微生物限度检查的方法并验证。方法按照《中国药典》2015年版要求，采用金黄色葡萄球菌、铜绿假单胞菌、枯草芽胞杆菌、白色念珠菌、黑曲霉和大肠埃希菌进行微生物限度检查方法验证。结果金柴胶囊对金黄色葡萄球菌、铜绿假单胞菌与枯草芽孢杆菌有较强的抑菌作用，增加稀释液（1∶50）后，明显消除了抑菌性；常规法下检查霉菌和酵母菌，回收比值均在0.5~2.0；控制菌方法适用性试验中试验组均检出试验菌。结论采用平皿法通过增加供试品稀释液法检查需氧菌数；采用常规平皿法检查霉菌、酵母菌计数；控制菌检查可采用常规法。所建立的方法适用于金柴胶囊的质量控制。%Objective To establish and validate a method of microbial limit test for Jinchai capsules.Methods The microbial limit test method was validated using Staphylcoccus aureu, Pseudomonas aeruginosa, Bacillus subtilis, Aspergillus niger, Candida albicansand Escherichia coli according to Chinese Pharmacopoeia Edition 2015.ResultsJinchai capsules have a strong inhibition on Staphylcoccus aureu, Pseudomonas aeruginosa and Bacillus subtilis. The antibacterial activity of the samples was eliminated after diluting the sample 1mL to 50mL. The recovery ratios for counts of mold and yeasts were all within 0.5-2.0 when using the routine plate count method, and the validation result of control bacteria was positive.Conclusion Medium dilution method can be used for total aerobic microbial count. The routine method can be used with enumeration mold and yeasts. Specified microorganisms can be tested when general method was applied. The method is effective and can be used to the quality control of the Jinchai capsules.