多品种共线的中药制剂清洁验证

Cleaning validation of Chinese materia medica preparation manufactured in shared production line

以实例介绍中药制剂多品种共线的清洁验证,从目标产品的选择、指标物质的确定、验证接受标准和分析方法 4个方面阐述中药制剂的清洁验证。将中药制剂中的浸膏或浸膏干粉整体作为验证的标记成分,并以全波长扫描的方法对该标记成分进行分析,是一种科学、合理且经济的验证策略。

This paper illustrates the company＇s cleaning validation of many varieties of Chinese materia medica（CMM） preparation manufatured in the same production line by real case from four aspects such as selection of target product, confirmation of marker, validation of acceptance criteria, and analytical methods. It is a scientific, rational, and economic validation strategy to use CMM preparation extract or the whole extract powder as marker components for validation and determination of the marker components using UV-full wavelength scan method.