"一测多评"法测定丹参酚酸类成分的含量

目的:建立适合于中药特点的利用一个对照品同步测定丹参中多种酚酸类成分的分析方法,并进行方法学考察.方法:以中药丹参为研究对象,以丹参素钠(sodium danshensu)为内参物,建立原儿茶醛(protocatechuic aldehyde)、迷迭香酸(rosmarinic acid)、紫草酸(lithospermic acid)和丹酚酸B(salvianolic acid B)与丹参素钠的相对校正因子.采用外标法测定丹参素钠,用相对校正因子计算丹参中其他4种酚酸类成分的含量;并将“一测多评”法的计算值与外标法实测值用相对偏差进行评价,以验证“一测多评”法的准确性和适用性.结果:丹参酚酸类成分“一测多评”法的计算结果与外标法的实测值之间没有显著性差异,相对偏差＜5％,实验所得的相对校正因子可信.结论:一测多评的质量评价模式在中药丹参酚酸类成分的多指标质量评价中得到验证,可为后续《中国药典》的品种修订提供参考.

A quantitative method for simultaneous assay of five ingredients with one marker in Salvia miltiorrhiza

Objective : To establish a new quantitative method for simultaneous determination of multi-components in Salvia miltiorrhiza by using one chemical reference substance and validate its feasibilities. Method : The new quality evaluation method, quantitative analysis of multi-components by singer-marker (QAMS), was established and validated with S. miltiorrhiza . Five main ingredients were selected as analytes to evaluate the quatity and their relative correlation factors (RCF) were determined by HPLC-DAD. Within the linear range, the values of RCF at 280 nm of sodium danshensu to protocatechuic aldehyde, rosmarinic acid, lithospermic acid and salvianolic acid B were 7.559, 2.901, 1.825 and 1.746, respectively. The contents of danshensu in the samples of S. miltiorrhiza were determined by using the external standard method, and the contents of the four other ingredients were calculated by their RCFS. The contents of these four ingredients in all samples were also determined by the external standard method. Result : Within a certain range, the RCFs showed good reproducibility (RSD 1.0%-2.5%). No significant differences were observed between the quantitative results of the two methods. Conclusion : It is feasible and suitable to evaluate the quality of S. miltiorrhiza and its processed products by QAMS.