坤泰胶囊微生物限度检查方法学研究

Test method for microbial limit of Kuntai capsules

目的:建立坤泰胶囊微生物限度检查方法。方法:按照《中国药典》2020年版四部通则1105、1106的要求进行方法适用性试验。结果:坤泰胶囊对铜绿假单胞菌、金黄色葡萄球菌和枯草芽孢杆菌均有较强的抑菌性,当样品稀释至50倍时,各试验菌回收比均在0.5~2.0范围内;控制菌检查常规法检出相应的控制菌。结论:坤泰胶囊需氧菌总数检查采用稀释法,霉菌和酵母菌总数检查采用常规法,控制菌检查采用常规法。

Objective:To establish a method for microbial limit of Kuntai capsules.Methods:According to the general chapters 1105 and 1106 of the Chinese Pharmacopoeia(2020 edition)VolumeⅣ,the applicability of the method was tested.Results:Kuntai capsules had strong bacteriostasis to Pseudomonas aeruginosa,Bacillus subtilis and Staphylococcus aureus.When the sample was diluted to 50 times,the recovery ratio of all tested bacteria was in the range of 0.5-2.0.The control bacteria were detected by conventional method.Conclusion:The total number of aerobic bacteria in Kuntai capsules was detected by dilution method.The total number of mold and yeast was detected by conventional method,and the control bacteria were detected by conventional method.