用ELISA法检验柴胡药材的质量

Quality inspection of commercial Bupluri Radix samples in Guangzhou: an ELISA for determining saikosaponin a content using anti-saikosaponin a monoclonal antibody

目的用酶联免疫吸附法（ELISA）测定广州市售柴胡药材中柴胡皂苷a（SSa）的含量,考察其质量情况。方法使用抗SSa单克隆抗体,建立竞争性酶联免疫吸附检测（ELISA）法,测定广州市售柴胡药材样品中的SSa含量。结果建立的竞争性ELISA法中,SSa在0.162.5μg/ml浓度范围内,与吸光度呈良好线性关系。10份市售柴胡药材中SSa的含量在0.326.87μg/mg之间。结论 ELISA是一种灵敏快捷、经济环保,特别适合于批量检测的SSa测定法。广州市售柴胡药材质量参差,约30%不符合药典要求。

Objective To inspect the quality of commercially available Chaihu （Bupluri Radix, a common traditional Chinese herbal drug） in Guangzhou by determining the content of saikosaponin a （SSa） using enzyme-linked immunosorbent assay （ELISA）. Methods A competitive ELISA system using mouse anti-saikosaponin a monoclonal antibody was established for determining SSa content. Commercial samples of Chaihu were obtained from 10 drug stores in Guangzhou, and SSa contents in the methanol extracts of these samples were determined using the ELISA system. Results The detection range of this competitive assay was 0.16-2.5 μg/ml for determining SSa contents. In the 10 commercial Chaihu samples, SSa contents in the methanol extract determined by this method ranged from 0.32 μg/mg to 6.87 μg/mg, and 3 samples showed a SSa content lower than the minimum requirement documented in the Chinese Pharmacopeia. Conclusions This competitive ELISA is sensitive, rapid, economic and environment-friendly for SSa determination, especially suitable for batch determination. The results of SSa detection for the commercial Chaihu samples demonstrate an uneven quality of Chaihu in Guangzhou market, suggesting the necessity of more rigorous quality control measures for this drug