中药口服液微生物污染溯源分析及污染风险的评价与控制

Traceable Analysis of Microbial Contamination to Traditional Chinese Medicine Oral Liquid and Its Evaluation and Control

本文以一起因微生物污染而导致的药品召回事件为例,通过生产过程回顾、阳性样品分析、培养条件优化、污染菌株分析、生产过程采样、调查结果分析和制定解决方案等步骤,详细介绍调查和检测流程,建立中药口服液微生物污染事件的调查程序和检测方法。通过有害微生物识别、有害微生物确认、关键区域控制和有效的检测方法四个步骤,建立原料药微生物污染评价与控制方法。调查结果表明,召回产品在生产过程中,因受到原料药携带的乳杆菌污染,而导致严重的质量问题。本文建立的中药口服液微生物污染风险评价与控制方法,可以有效降低生产过程中产品受污染的风险。

Based on a drug recall case caused by microbial contamination, the detailed investigation and test process was elaborated by following the steps of production process review, positive sample analysis, optimization of culture conditions, analysis of contaminated strains, production process sampling, analysis of survey results, and establishment of solutions, so that investigation procedures and test methods for microbial contamination to traditional Chinese medicine oral liquid could be established. Furthermore, evaluation and control methods for microbial contamination could be established by the following four steps such as harmful microorganism identification, harmful microorganism characterization, critical control point and effective detection method. The investigation results showed that the recalled products, contaminated by lactobacillus carried by the crude medicinal materials, had serious quality deficiency. Isolation and characterization methods on microbial contamination of traditional Chinese medicine oral liquid played a significant role in the prevention of microbial contamination to products during production.