中药饮片耐胆盐革兰阴性菌量化风险评估研究

Quantitative Risk Assessment of Bile Salt-Resistant Gram-Negative Bacteria in Traditional Chinese Medicine Decoction Pieces

目的建立中药饮片耐胆盐革兰阴性菌的量化风险评估方法。方法收集中国知网2012年1月1日至2021年12月31日耐胆盐革兰阴性菌数据,采用潜在失效模式和效应分析模型,从耐胆盐革兰阴性菌可能的种类、生物负载等角度进行分析,并将风险指标量化,评估风险等级。结果共纳入中药饮片品种53个(760批次)。穿心莲、两头尖、部分枸杞和部分麦冬饮片污染风险高(6.25%),红花、夏枯草和部分菊花饮片污染风险中等(4.69%),其余饮片污染风险低(89.06%)。枸杞等10个品种中药饮片中有7种(除枸杞、麦冬、菊花外)风险评估结果一致。结论建立的中药饮片耐胆盐革兰阴性菌的量化风险评估方法可行,为中药饮片的微生物控制提供了参考依据,是对当前中药饮片外源性污染物风险评估模型的补充。

Objective To establish a quantitative risk assessment method of bile salt-resistant Gram-negative bacteria in traditional Chinese medicine(TCM)decoction pieces.Methods Data on the bile salt-resistant Gram-negative bacteria in the CNKI from January 1,2012 to December 31,2021 were collected and analyzed from the possible species and bioburden of these bacteria by the potential failure mode and effect analysis(FMEA)model.Risk indicators were quantified to assess the level of risks.Results A total of 53 varieties(760 batches)of TCM decoction pieces were included.The risk of contamination was high in Andrographis Herba,Anemones Raddeanae Rhizoma,partial Lycii Fructus and partial Ophiopogonis Radix decoction pieces(6.25%),that was medium in Carthami Flos,Prunellae Spica and partial Chrysanthemi Flos decoction pieces(4.69%),and that was low in other TCM decoction pieces(89.06%).The risk assessment results of seven out of ten TCM decoction pieces(including Lycii Fructus and others)were consistent,except for Lycii Fructus,Ophiopogonis Radix and Chrysanthemi Flos.Conclusion The established quantitative risk assessment method of bile salt-resistant Gram-negative bacteria in TCM decoction pieces is feasible,which can provide a reference for microbial control in TCM decoction pieces,and it is a supplement to the current risk assessment model for exogenous contamination in TCM decoction pieces.