目的 通过17个省市药检所在国内市场采购的151种2 286批饮片样本收集检验,客观真实地反映当前国内中药饮片污染微生物情况,对中药饮片污染微生物的控制问题形成共识。方法 获得国内饮片需氧菌总数(TAMC)、霉菌和酵母菌总数(TYMC)、耐热菌数及耐胆盐革兰阴性菌数的数量结果。参考国内外通行的微生物计数方法和标准控制限值,比较国内饮片与国外标准之间的关系。结果 饮片中污染的微生物在不同类别间、同品种内部都呈现出较大的不确定性。煎煮类饮片污染微生物数量高于直接服用类饮片。比对不同国外计数标准,约3%煎煮类饮片不能满足EP/JP要求,17%煎煮类饮片不能满足USP要求;约5%直接服用饮片不能满足EP/JP要求,15%直接服用饮片不能满足USP要求。不能满足标准要求的饮片未呈现特定规律,大多为部分品种的部分批次。结论 中药饮片污染微生物受限于品种采收加工等诸多影响因素,污染微生物具有高度的不确定性。目前按照国际共识,将饮片按其用途分为煎煮和直接服用两大类控制污染微生物的总量,是理想是较适宜的质控策略。随着中药材及中药饮片标准化水平的提高,饮片微生物质量控制水平也会得到提升。
Abstract
OBJECTIVE To examine the microbial enumeration of a sample with 2286 batches of 151 species of prepared slices of Chinese crude drugs in the domestic markets where 17 drug quality control institutes were located, thus to authentically reflect the microbial contaminated status and reach a consensus on the necessity of microbial control of prepared slices of Chinese crude drugs. METHODS The results of total aerobic microbial count(TAMC), total combined yeasts/molds count(TYMC), total heat-resistant microbial count(THRC), and bile-tolerant Gram-negative bacteria of domestic prepared slices of Chinese crude drugs were obtained. Referring to the general microbial enumeration methods and international control criteria, the conformity of the prepared slices of Chinese crude drugs to the foreign criteria was analyzed. RESULTS There were big uncertainties about the microbial contamination not only among different kinds of prepared slices but also in the same kind. The microbial quantity of prepared slices to be decocted was higher than that of prepared slices to be taken directly. Among the prepared slices to be decocted, about 3% did not meet EP/JP criteria, and 17% did not meet USP requirements. When it came to prepared slices to be taken directly, about 5% did not meet EP/JP criteria, and 15% did not meet USP requirements. There was no significant tendency in prepared slices which did not satisfy the requirements stated above. Mostly they were just a few batches of some species. CONCLUSION Microbial contamination of prepared slices of Chinese crude drugs is affected by harvest time, processing, and many other factors. So, the uncertainty of microbial contamination of prepared slices are high. As to the current international consensus, it is a suitable strategy for the microbial control of prepared slices of Chinese crude drugs to divide them into two categories based on the application way. One category is prepared slices to be decocted, and the other is prepared slices to be taken directly. With the standardization development of Chinese crude drugs and prepared slices of Chinese crude drugs, the microbial control of prepared slice would be improved also.
关键词
饮片 /
微生物污染 /
需氧菌总数 /
霉菌和酵母菌总数 /
耐热菌数 /
耐胆盐革兰阴性菌 /
煎煮类饮片 /
直接服用类饮片
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Key words
prepared slices /
microbial contamination /
total aerobic microbial count(TAMC) /
total combined yeasts/molds count(TYMC) /
total heat-resistant microbial count(THRC) /
bile-tolerant Gram-negative bacteria /
prepared slices to be decocted /
prepared slices to be taken directly
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中图分类号：
R291.2
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