中成药口服给药制剂及其原料药微生物污染相关性分析

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 investigate the correlation of microbial contamination of oral preparations of Chinese patent medicine and crude drugs by identification of pollution strains isolated from them. Methods: The microbial limit tests of Liuwei Dihuang pills,Niuhuang Xiaoyan tablets,Xihuang pills and their main traditional Chinese medicinal materials were analyzed in accordance with the corresponding methods in the appendix of China pharmacopeia(2010 edition,volumeⅠ)and the Japanese pharmacopoeia(16 edition)and the strains were identified by automatic bacteria identification test system. Results: The bacterial strains isolated from them were basically the same and were commonly seen in the environment. Conclusion: The bacteria of sample preparations are mainly from raw herbal materials.There exists a certain correlation between microbial contaminations of traditional Chinese medicine preparations and that of raw medicinal material.Control of crude drugs microbial pollution is an important factor to ensure the quality of oral preparations of Chinese patent medicine.