关键词: font-size:medium, ">橘红颗粒；微生物限度检查；方法适用性试验

Abstract: Objective：To establish the microbial limit test method of juhong granules. Methods： According to the general rules 1105， 1106 and 1107 of the fourth part of Chinese Pharmacopoeia (2020 edition)， the applicability of the microbial limit test method was studied. Results： The plate method and membrane filtration method were used to carry out the applicability test of aerobic bacteria count method， and the plate method was used to carry out the applicability test of mold and yeast count method. The microbial recovery ratio was 0.5-2.0， indicating the drug had no bacteriostasis to the positive test bacteria. The applicability test of the control bacteria (Escherichia coli) inspection method was conducted by using the conventional method and the method of increasing the volume of culture medium. Positive bacteria were detected in both the test group and the positive control group， indicating the drug has no bacteriostasis to Escherichia coli. Conclusion： The plate method (1∶10) can be used to check the total number of aerobic bacteria， mold and yeast， and the routine method can be used to check the control bacteria. The method is easy to operate and has good repeatability， which can be used for microbial limit test of juhong granules.

Key words: font-size:medium, ">Juhong granules； Microbial limit test； Method suitability test