独一味软胶囊中2种活性成分溶出度比较研究

Comparative Study of Dissolution on Two Active Components of Duyiweisoft Capsules

目的:建立同时快速测定独一味软胶囊中山栀苷甲酯与8-O-乙酰基山栀苷甲酯(ASME)2种成分含量的方法,测定体外溶出度并考查其溶出特点。方法:采用桨法,以250mL 0.1mol/L盐酸溶液为溶媒,转速为100r·min^(-1),采用HPLC法测定独一味软胶囊中2种成分的溶出度,并计算累积溶出度,采用相似因子(f_2)法对溶出度曲线进行相似性比较。结果:山栀苷甲酯与8-O-乙酰基山栀苷甲酯的相似因子为74.11。结论:该研究建立了快速测定独一味软胶囊中2种成分的HPLC方法,以0.1mol/L盐酸溶液为溶出介质时,独一味软胶囊中2种成分的溶出度具有同步性,为独一味软胶囊的质量标准提供了参考依据。

Objective： To establish anHPLCmethod for the simultaneous determination ofshanzhisidemethylester and r8-O-acetyls hanzhisidemethyl esterof Duyiweisoft capsule, and study the dissolution characteristics oftwoactive components in vitro. Methods： The paddle method was used with 250mL 0. l mol^ L^-1 hydrochloric acid as the dissolution medium,and the rotate speed was 100r·min^-1. The contents of active components were determined by HPLC. The accumulative dissolution percentages were calculated and the resemblance of release curves were compared by similarity factors （f2）. Results：The similarity factors of Shanzhisidemethylester and rS-O-acetylshanzhisidemethyl esterwasg0.47. Conclusion ： HPLC method for the simultaneous determination oftwoactive componentof Duyiweisoft capsule was establish. The dissolution ofshanzhisidemethylester and r8-O-acetylshanzhisidemethyl ester have the same characteristics of synchronous dissolution in 0. 1mol·L^-1 hydrochloric acid. It can be for the quality control of Duyiweisoft capsule.