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目的:建立景天清肺胶囊微生物限度检查的方法并验证。方法:按《中国药典》2015年版四部非无菌药品微生物限度检查:微生物计数法、控制菌检查法和限度标准规定进行方法适用性试验。结果:采用常规倾注法检查需氧菌总数、霉菌和酵母菌总数,试验组回收率均在0.5~2范围内;控制菌方法适用性试验中试验组均检出试验菌。结论:采用常规平皿法检查需氧菌总数和霉菌、酵母菌计数;控制菌检查可采用常规法。所建立的方法适用于景天清肺胶囊的质量控制,方法简便,结果可靠。
Objective: To establish and verify the method of limiting the microbiological limit of Sedum Qingfei Capsule. Methods: According to the Chinese Pharmacopoeia 2015 edition four non-sterile drug limit of microbial tests: microbial count method, control bacteria test method and limit standards for method suitability test. Results: The total number of aerobic bacteria, molds and yeasts were checked by conventional pouring method. The recoveries of the test groups were in the range of 0.5 ~ 2. The test strains were all detected in the test group in the suitability test of control bacteria. Conclusion: The routine plate method to check the total number of aerobic bacteria and mold, yeast count; control bacteria can be checked by conventional methods. The established method is suitable for the quality control of Sedum Qingfei Capsule, the method is simple and the result is reliable.