Verification of Microbial Limit Test Method for Wushicha Granule

According to the requirements of the Pharmacopoeia of the People's Republic of China (Part 4, 2020 edition), the applicability of calculation method of microbial and control bacteria examination method for Wushicha granule were tested by the plate pouring method (1∶10, 1∶20, 1∶50, 1∶100) and the routine medium volume direct inoculation method. The total aerobic microbial count, fungi and total saccharomyces cerevisiae count method were screened by calculating the recovery ratio of the test bacteria in three batches. When the plate pouring method (1∶10) was used, the recoveries of each test bacterium were within the range of 0.5~2.0. The positive control group of control bacteria grew well, and through gram staining microscopic examination and biochemical identification tests, it met the morphological and biochemical characteristics of the test bacteria. The method is accurate, feasible, reproducible, and can be used for microbial limit testing of Wushicha granule.