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目的:通过对六味地黄丸、牛黄消炎片和西黄丸及其原料药污染菌株的鉴定与分析,探讨中成药口服给药制剂与其原料药检出污染微生物的相关性。方法:参考中国药典2010年版和日本药典16版方法,测定六味地黄丸、牛黄消炎片和西黄丸及其主要原料药中的细菌、霉菌和酵母菌数,采用全自动细菌鉴定试验系统对检出的污染菌进行菌株鉴定。结果:从六味地黄丸、牛黄消炎片和西黄丸及其主要原料中检出的污染菌株基本相同,且多为环境常见菌。结论:六味地黄丸、牛黄消炎片和西黄丸检出的污染菌主要来自原料药,即制剂与原料药微生物污染具有相关性,故控制原料药的微生物污染是保证中成药口服给药制剂质量的重要因素。
OBJECTIVE: To identify and analyze the contaminated strains of Liuweidihuang Pill, Bezoar anti-inflammatory tablet and Xihuang Wan and their raw materials, and to explore the correlation between the oral administration of proprietary Chinese medicines and the detection of contaminated microorganisms by their raw materials. Methods: With reference to the Chinese Pharmacopoeia 2010 edition and the Japanese Pharmacopoeia 16 edition, the numbers of bacteria, molds and yeasts in Liuweidihuangwan, Bezoar anti-inflammatory tablets and Xihuangwan and their main drug substances were determined. The automatic bacterial identification test system was used to check Out of the contaminated bacteria strain identification. Results: The contaminated strains detected from Liuweidihuangwan, Bezoar anti - inflammatory tablets and Xihuang Wan and their main raw materials were basically the same, and were mostly common bacteria in the environment. Conclusion: The contaminated bacteria detected by Liuwei Dihuang Pill, Niuhuang Xiaoyan Pian and Xuan Huang Pills mainly come from APIs, that is, the formulations are related to the microbial contamination of APIs. Therefore, controlling the microbial contamination of APIs is to ensure the quality of oral administration of proprietary Chinese medicines The important factor.