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.
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2021, Vol. 56 
