Objective To establish the method of microbial limit test of Fufang Huangliansu tablets. Methods According to the provisions of Part Four of the 2020 edition of the Pharmacopoeia of the People's Republic of China, the applicability test of microbial limit testing methods shall be gradually carried out using methods such as plate pouring method, increasing dilution ratio, and dilution combined with membrane filtration. Results The membrane filtration method was used for aerobic bacteria counting. The medium dilution method was used for counting total combined molds and yeasts. The direct inoculation method was used for three types of control bacteria that must be tested according to drug standards. Conclusion The microbiological limit test method for this drug proposed in this experiment is simple and easy to implement.

Fufang Huangliansu tablets  /  microbial limit  /  validation of method  /  plate pouring method  /  membrane filtration method