中国中药杂志

2010, v.35(24) 3270-3273

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

李家春;梁娜;肖伟;毕宇安;王振中;
LI Jiachun,LIANG Na,XIAO Wei,BI Yu′an,WANG Zhenzhong(Jiangsu Kanion Pharmaceutical Co.,Ltd.,Lianyungang 222001,China)

摘要(Abstract):

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RSD<15%。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。
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.

关键词(KeyWords): 桂枝茯苓胶囊;定量指纹图谱;过程质量控制;指标性成分
Guizhi Fuling capsule;quantitative fingerprint technique;in-process quality control;marked components

Abstract:

Keywords:

基金项目(Foundation): 国家“重大新药创制”科技重大专项(2009ZX09504-004)

作者(Author): 李家春;梁娜;肖伟;毕宇安;王振中;
LI Jiachun,LIANG Na,XIAO Wei,BI Yu′an,WANG Zhenzhong(Jiangsu Kanion Pharmaceutical Co.,Ltd.,Lianyungang 222001,China)

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