中药颗粒剂中不可接受微生物的溯源分析和风险评估

目的 溯源中药颗粒剂中检出的不可接受微生物，并进行污染微生物的风险评估。方法 对产品中检出的污染菌进行鉴定，评估其危害性，通过生产环节采样培养、微生物分离鉴定、核糖体分型和亲缘关系分析等手段，溯源污染菌。结果 产品中主要污染菌为阴沟肠杆菌，与制剂总混间环境中分离到的阴沟肠杆菌高度同源，评价该菌株为中等风险不可接受菌。结论 本文建立了中药颗粒剂中污染微生物的溯源与危害程度评价方法，为同类产品的微生物污染风险排查提供依据。

Traceablity of objectionable miroorganisms from a traditional Chinese medicine granule and risk assessment of contaminant miroorganisms

Objective To trace a strain of objectionable microorganism that was found in a traditional Chinese medicine granule, and to complete risk assessment of contaminant microorganisms.Methods All of investigations and tests were elaborated by the following steps of species identification, production process sampling, microbial separation and purification, analysis of traceability. And all contaminant microorganisms were identified by VITEK 2 compact microbiology analysis system and were traced by RiboPrinter automatic genetic fingerprint identification technology (RP). Rusults A bacterial strain of Enterobacter cloacae exist in this granule as a large microbial load. RP showed close relationship between two strains of Enterobacter cloacae isolated from the medicine granule and the ground in blending room. The strain of Enterobacter cloacae was evaluated for medium-risk objectionable microorganism of this traditional Chinese medicine granule. Conclusion An effective isolation and tracing method on microbial contamination of a traditional Chinese medicine granule played a significant role in the risk assessment and management of pharmaceutical production.