一测多评法测定3种中成药中4种指标性成分研究

目的：建立一测多评法测定3种中成药（三黄片、一清颗粒、一清胶囊）中4种指标性成分（大黄素、大黄酚、盐酸小檗碱、黄芩苷）的分析方法。方法：以黄芩苷作为参照物，建立其与大黄酚、盐酸小檗碱和大黄素间的相对校正因子。分别采用外标法和一测多评法测定3种中成药中的4种指标性成分的含量，并对2种方法计算结果进行对比分析，以验证一测多评法的实用性与稳定性。结果：一测多评法的计算结果与外标法的实测值之间RSD<1.5%，一测多评法与外标法在含量测定上无明显差异。实验所得的相对校正因子RSD<2%，无明显差异，其结果可信。结论：本研究建立的以黄芩苷为参照物的一测多评法适用于测定大黄酚、盐酸小檗碱、大黄素成分的含量，该方法准确、简便、可行。

Determination of four index components in three proprietary Chinese medicines by QAMS

OBJECTIVE To establish a quality evaluation method, quantitative analysis of multi-component with a single-marker (QAMS), to determine contents of four index components (emodin, rhubarb phenol, berberine hydrochloride, baicalin) of three proprietary Chinese medicines (Sanhuang tablets, Yiqing grain, Yiqing capsule).METHODS Baicalin was used as internal reference. Relative correlation factors (RCF) of emodin, rhubarb phenol, berberine hydrochloride to baicalin were calculated and evaluated. These four index contents were determined by external standard method and QAMS to compared results obtained from two different methods and verify practicability and stability of QAMS.RESULTS Measured value of RSD between two methods was less than 1.5%. Analysis of two methods had no significant difference. RSD of relative correlation factors (RCF) was less than 2%.CONCLUSION QAMS method can be used as a new quality assessment model for quantitative analysis.