中药饮片污染耐胆盐革兰阴性菌的考察

Investigation of Chinese Medicinal Decoction Pieces Contaminated by Bile Salt Resistant Gram-Negative Bacteria

目的:考察中药饮片耐胆盐革兰阴性菌的污染状况。方法:依据2015年版《中国药典》微生物限度检查法草案中耐胆盐革兰阴性菌检查方法对中药饮片耐胆盐革兰阴性菌进行定性检查,对阳性样品进行定量检查,比较预培养2 h和不预培养两种方法对耐胆盐革兰阴性菌定量检出的差异。结果:通过对17个品种174批中药饮片的考察,结果显示中药饮片耐胆盐革兰阴性菌污染比较严重,达81.0%。按2015年版《中国药典》中药饮片耐胆盐革兰阴性菌标准来判断,16.1%不合格,且预培养2 h和不预培养两种方法检验结果没有显著差异(P>0.05)。结论:本研究可为2015年版《中国药典》中药饮片耐胆盐革兰阴性菌限度标准的制定提供参考依据。

Objective：To investigate the contamination status in Chinese medicinal decoction pieces by bile salt resistant Gram-negative bacteria.Methods：Based on the protocol of microbial limit test method in Chinese Pharmacopoeia 2015 edition, the bile salt resistant Gram-negative bacteria in Chinese medicinal decoction pieces were detected qualitatively, then the positive samples were examined quan-titatively.The difference of two methods between pre cultured for 2 hours and no pre cultured was compared.Results：By detecting 174 batches of 17 varieties of decoction pieces, the contamination rate of bile salt resistant Gram-negative bacteria reached 81.0%.According to the limit standard of Chinese Pharmacopoeia 2015 edition, 16.1%Chinese medicinal decoction pieces are unqualified.There is no sig-nificant difference between two methods （ P〉0.05 ）.Conclusion：The research can provide reference basis for Chinese Pharmacopoeia 2015 edition in the limit standard of bile salt resistant gram-negative bacteria of Chinese medicinal decoction pieces.