一测多评法同时测定雷公藤药材及制剂雷公藤多苷片中7个质控成分

目的 为提高雷公藤质量控制水平，建立同时测定雷公藤药材及制剂雷公藤多苷片中7个成分的一测多评（quantitative analysis of multi-components with a single-marker，QAMS）方法。方法 采用HPLC法，以雷酚内酯为参照物，计算其它6种成分雷公藤甲素、雷公藤内酯酮、雷公藤晋碱、雷公藤次碱、雷公藤红素和雷公藤内酯甲的相对校正因子（f_k/s），并对f_k/s进行耐用性考察。搜集不同产地、厂家及不同批号的9批雷公藤药材和10批雷公藤多苷片，分别采用外标法和QAMS法测定7个成分含量，比较两者的差异。结果 各个成分的f_k/s重复性良好，对19批样品运用QAMS法和外标法得到的各成分含量无显著性差异（相对平均偏差＜3%）；不同厂家、不同批号及不同产地来源的雷公藤多苷片及雷公藤药材中7个成分含量均存在较大差异，说明应提高雷公藤中药的质量控制标准。结论 所建立的QAMS法准确性高，可用于雷公藤药材及其相关制剂的多成分同时定量分析，为雷公藤中药的全面质量控制提供方法参考。

Simultaneous quantitative determination of seven components in Tripterygium wilfordii herbs and preparations of Tripterygium wilfordii polyglycosides Tablets by QAMS method

Objective To improve quality control level of Leigongteng (Tripterygium wilfordii), a traditional Chinese medicine, the method of quantitative analysis of multi-components with a single-marker (QAMS) was established to simultaneously determine seven components in T. wilfordii herbs (TWH) and preparations of Tripterygium wilfordii polyglycosides Tablets (TWPT). Methods Using triptophenolide as the reference, the relative correction factors (f_k/s) of other components of triptolide, triptonide, wilforgine, wilforine, tripterine and wilforlide were calculated by HPLC, and then the durability of f_k/s was investigated. Nine samples of TWH and 10 samples of TWPT from different origins, manufacturers and batch numbers were collected and their components were determined using the external standard method (ESM) and QAMS method, respectively. The determination results of sevem components in 19 samples using ESM and QAMS method were compared. Results The repeatability of f_k/s for each component was good. There was no significant difference (RAD < 3%) between the measured values of QAMS method and ESM. The components contents in TWH from different origins and TWPT from different manufacturers and batch numbers were both greatly different. The results demonstrated quality control standard of T. wilfordii should be improved. Conclusion The established QAMS method has high accuracy and it can be used for the simultaneous quantitative determination of multiple components in TWH and preparations of T. wilfordii. This method will provide a method reference for the comprehensive quality control of T. wilfordii.