Study on the applicability of microbial limit test methods for Banlangen granule and Ganmao Qingre granule
Objective:To test the applicability of the microbial limit test methods for Banlangen granule and Ganmao Qin-gre granule.Methods:According to the four microbial limit test methods in the 2020 edition of the《Chinese Pharmacopoeia》,the suitable methods for Banlangen granule and Ganmao Qingre granule were selected from the plate method,dilution method,and membrane filtration method,and the antibacterial ability of the two drugs was roughly judged.Results:The re-covery rate of aerobic bacterial count,mold count,and yeast count in Ganmao Qingre granule was higher than 0.5,which met the requirements of the method applicability test.The recovery rate of Banlangen granule using the plate method(except for Aspergillus niger)was lower than 0.5.The dilution and membrane filtration methods can meet the requirements of a recovery rate within the range of 0.5～2,which met the requirements of the method applicability test.Conclusion:This study indicates that when testing the microbial limit of Banlangen granule and Ganmaoqingre granule,the Ganmaoqingre granule can be test-ed using the plate method,the Banlangen granule can be tested using the dilution and membrane filtration method,and the control bacteria can be tested using the routine method of Escherichia coli.
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