Objective To establish a method for microbial limit test of Yikang Capsules. Methods The applicability of Yikang Capsules was studied according to general rules 1105,1106,1107 of the fourth part of the 2020 edition of Pharmacopoeia of the People's Republic of China.Firstly,the pan pour method(1∶10)was used to carry out the preliminary test.By calculating the recovery ratio of strains, the bacterial strains sensitive to Yikang Capsules were screened according to the standards.Then, the antibacterial activity of Yikang Capsules was removed by increasing the volume of diluent. Results When the total number of aerobic bacteria was 1∶20 and the total number of molds and yeasts was 1∶10,the recovery ratio of each test strain was in the range of 0.5-2.Control bacteria examination when conventional examination method was used, positive control group grew well, negative control group did not grow colony, all in line with the standard requirements. Conclusion The total number of aerobic bacteria by plate pouring method (1∶20), the total number of mold and yeast by plate pouring method (1∶10), the control bacteria inspection by conventional inspection method, the method is effective, feasible and reproducible, and can provide a reference for drug manufacturers or related drug inspection agencies to carry out microbial limit test of Yikang Capsules.
曹鲁娜;任颖慧;毕言锋;王 静. 益康胶囊微生物限度检查方法适用性研究[J]. 中国当代医药, 2022, 29(23): 43-45转49.
CAO Lu'na REN Yinghui BI Yanfeng WANG Jing▲. Study on the applicability of microbial limit test for Yikang Capsules. 中国当代医药, 2022, 29(23): 43-45转49.