金青醇沉生产工艺的关键质控风险因素辨识

Identifi cation of Critical Risk Factors for Quality Control in Alcohol Precipitation Process of Flos Lonicerae japonicae and Herba Artemisiae annuae Extracts

基于对金青醇沉生产工艺的全面监测,建立了定性和定量相结合的辨识实际生产过程中关键质控风险因素的方法。采用因果图、潜在失效模式和效果分析,初步定性辨识潜在质控风险因素。随机采集并测定金青醇沉正常生产样品,并同步监测潜在质控风险因素,建立了描述各项潜在质控风险因素对6个有效成分回收率和固含物去除率等指标影响的定量模型,并由模型筛选获得影响醇沉工艺稳定性的关键质控风险因素。结果表明,现行金青醇沉生产工艺的关键质控风险因素为加醇量和浸膏密度,须根据质控要求适当缩小该参数的控制范围,以提高金青醇沉生产工艺的质量控制水平。

Based on comprehensive monitoring the manufacturing process of alcohol precipitation of Flos Lonicerae japonicae and Herba Artemisiae annuae extracts （FHE）, a qualitative and quantitative method was developed to identify the critical risk factors affecting the stability of production process for quality control. Quality risk assessment tools, such as fishbone diagram, failure modes and effects analysis （FMEA）, were used to identify the potential risk factors. With collecting the normal production samples from the alcohol precipitation process of FHE in random and monitoring the fluctuation of the potential risk factors simultaneously, seven quantitative models were established for describing the impact of each potential risk factor on the recoveries of six active ingredients and the dry matter removal of alcohol precipitation. The consumption of ethanol and extract density, which significantly affected all of the seven evaluation indexes, were regarded as the key quality control risk factors that influenced the stability of alcohol precipitation process. In order to improve the quality control accuracy of alcohol precipitation process of FI-IE, the fluctuation range of these two critical risk factors should be reduced appropriately according to production requirement of pharmaceutical factory.