定量指纹图谱技术在桂枝茯苓胶囊过程质量控制中的应用

目的:采用定量指纹图谱为主要技术手段,评价中药生产过程中产生的中间体,建立起中药生产过程控制模式。方法:以桂枝茯苓胶囊为例,通过对生产工艺过程中产生的40%醇提浸膏、水提浸膏、混合浸膏、软材及成品的定量指纹图谱的测试,考察其生产工艺的稳定性和可重复性。结果:4种中间体及成品各自10批指纹图谱的相似度为0.966~0.999,10批成品指纹图谱中没食子酸、芍药苷、苯甲酸、肉桂酸、苯甲酰芍药苷、桂皮醛及丹皮酚等特征峰定量结果的RSD15%。结论:该方法准确、可行,对中药过程质量控制是一种有效的方法。

Application of quantitative fingerprint technique for in-process quality control of Guizhi Fuling capsules

Objective : To investigate an evaluation mode FOR in-process quality control for traditional Chinese medicines by adopting quantitative fingerprint technique as the main mean. Method : Regarding Guizhi Fuling capsules as an example, the stability and repeatability were observed by tests of quantitative fingerprint of 90% ethanol extract, aqueous extract, the final mixing extract, soft material and products during the production process. Result : The fingerprint similarities of four kinds of intermediates and products from 10 batches of Guizhi Fuling capsules were in the range of 0.966-0.999, respectively. The RSD of quantitative results of marked components, which included gallic acid, paeoniflorin, benzoic acid, cinnamic acid, benzoyl paeoniflorin, cinnamic aldehyde, paeonol, etc, were less than 15% in the products. Conclusion : This method is accurate, feasible and could be an effective way to be applied to in-process quality control of traditional Chinese medicine.