| 摘要 |
[Objectives] To establish a microbial limit test method for Wuteng Qufeng Zhitong Powder, ensuring its compliance with the relevant requirements of the Chinese Pharmacopoeia 2020 Edition. [Methods] In accordance with the Chinese Pharmacopoeia 2020 Edition, General Chapters Part IV, 1105 and 1106, method suitability tests were conducted for the total aerobic microbial count (TAMC), total yeasts and molds count (TYMC), and for the specified microorganisms (Staphylococcus aureus, Pseudomonas aeruginosa). Representative test strains, including Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans, and Aspergillus niger, were employed in spiked recovery tests using the pour plate method to calculate the recovery ratio. Validation was performed on three batches of the product. [Results] The recovery ratios for all test strains fell within the range of 0.5 to 2.0. In the specified microorganism tests, the corresponding strains were successfully detected in the test groups, indicating that the established test sample preparation method effectively neutralized the sample's potential antimicrobial activity. The microbial limit test results for all three batches complied with the specifications. [Conclusions] The established microbial limit test method is accurate, reliable, and suitable for the microbiological quality control of Wuteng Qufeng Zhitong Powder. |
