基于一测多评法对延胡索中生物碱类成分的质量控制研究

Quality control for alkaloids of Corydalis Rhizoma based on quantitative analysis on multi-components with single marker

目的建立同时测定延胡索中原阿片碱、黄连碱、黄藤素、去氢延胡索甲素、D-四氢药根碱、延胡索乙素和延胡索甲素7种生物碱类成分的HPLC方法,在此基础上,建立一测多评法的方法学考察方式,验证该方法在延胡索质量控制中应用的可行性和技术适用性。方法以延胡索所含的7种成分为指标成分,采用2种校正方法分别建立各成分与延胡索乙素的相对校正因子(fk/s),计算各成分的量,实现一测多评;同时采用外标法测定延胡索中该7种成分的量,并比较2种一测多评法所得计算值与实测值的差异,以验证一测多评法的准确性和可行性。结果建立了延胡索中7种生物碱类成分一测多评法方法学的考察模式;不同的色谱柱和仪器一测多评法的计算值与外标法实测值之间没有显著性差异。结论同时测定延胡索中原阿片碱、黄连碱、黄藤素、去氢延胡索甲素、D-四氢药根碱、延胡索乙素和延胡索甲素7种生物碱的一测多评法可靠,结果准确,可用于延胡索药材的质量控制。

Objective To establish an HPLC method for simultaneous assay of seven main active constituents（protopine,coptisine,palmatine,dehydrocorydaline,D-tetrahydro jatrorrhizine,tetrahydropalmatine,and corydaline） in Corydalis Rhizoma,and on this basis,establishing a methodology of quantitative analysis on multi-components by single marker（QAMS） to validate the feasibility of method and technical adaptability of quality control applications for Corydalis Rhizoma.Methods Taking seven components in Corydalis Rhizoma as indicators,two correction methods were used to establish the relative correction factor（fk/s） between each component and tetrahydropalmatine.Then the correction factor was used to calculate the amount of each component in Corydalis Rhizoma and finally to achieve this method.In the meantime,the external standard method was used to measure the above seven components to compare the difference between the calculated and measured value of the two fk/s,and to validate the correctness and adaptability of QAMS.Results The methodology of QAMS which was used to evaluate the seven kinds of alkaloids in Corydalis Rhizoma was established;There was no significant difference between the data calculated by QAMS in different columns and instruments and the values measured by the external standard method.Conclusion The QAMS method for measuring the components of protopine,coptisine,palmatine,dehydrocorydaline,D-tetrahydro jatrorrhizine,tetrahydropalmatine,and corydaline in Corydalis Rhizoma is reliable and accurate,it could be used to control the quality of crude drugs and herbal pieces of Corydalis Rhizoma.