中药质量一致性评价体系-基于定量指纹图谱检查的中药标准制剂控制模式的解析

TCM quality evaluation consistency system-the analyses for control mode of standard preparation based on quantitative fingerprints

目的阐述中药质量一致性评价体系的基本架构。方法解析中药标准制剂概念和建立方法,剖析中药参比制剂的基本内涵。二者既有区别又有必然联系。增加【指纹图谱检查】是中药质量一致性评价体系的基础,用宏定性相似度大于0.90,宏定量相似度在80%≤Pm≤120%作为基本控制方法。结果基于系统指纹定量法的标准制剂控制模式或者参比制剂控制模式是中药质量一致性评价的有效方法,从宏观战略角度拓展中国药典应采用定量指纹图谱对中药化学指纹物质进行整体幅度控制。结论中药标准制剂和中药参比制剂都是新生事物,二者是中药质量一致性评价体系的基石。基于三固色谱柱和指纹系统定量校正系数,采用中国药典的标准指纹图谱法可实现中药质量一致性的宏观定量控制。

Objective To elaborate the quality evaluation consistency system of Traditional Chinese Medicine （TCM）. Methods The basic concept of TCM standard preparation and its developing method were expounded, and TCM reference preparation was further analyzed, showing both relevance and difference. The appendix of TCM fingerprints check item was added as the base of concistency evaluation of TCM, in which the macro qualitative similarity of the sample fingerprints no less than 0.90 and the macro quantitative similarity 80% ~ Pm ~〈 120% were used as the fixndmental control method. Results Both the control mode of TCM standard preparation based on the systematic quantified fingerprint method and the control mode of TCM reference preparation were effective methods to evaluate TCM concistency. From the macro strategy expanding Chinese Pharmacopoeia should control the total chemicals within the lower limit and the upper limit. Conclusion Both TCM standard preparation and TCM reference preparation are novel things, and are keystones for TCM. Can we finish the concistency of TCM only we adopt the standard fmgerprint method from chinese pharmacopoeia, which based on the three constant for columns and the quantitative correction coefficient for the systematic fingerprint.