摘要
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.
出处
《亚太传统医药》
2016年第12期27-29,共3页
Asia-Pacific Traditional Medicine
关键词
独一味软胶囊
溶出度
相似因子
Duyiweisoft Capsules
Dissolution Rate
Similarity Factor