贞丹浓缩丸的溶出度研究

The Dissolution Study in Zhen Dan Concentrated Pill

目的建立贞丹浓缩丸中齐墩果酸、盐酸小檗碱的体外溶出度测定方法。方法采用小杯法,以200 mL 2%十二烷基硫酸钠溶液为溶出介质,转速100 r·min^(-1);高效液相色谱(HPLC)法测定贞丹浓缩丸中2种成分的溶出度,计算累积溶出度。结果贞丹浓缩丸中齐墩果酸、盐酸小檗碱的累积溶出度分别为71.94%、86.44%。结论该方法简便可靠,重复性好,适用于贞丹浓缩丸溶出度的测定,可为其质量评价提供依据。

OBJECTIVE To establish a method of determining external dissolutionof oleanolic acid, berberine hydrochloride in Zhen Dan Concentrated Pills（ZDCP）. METHODS The small glass-method was used with 200 mL 2% sodium lauryl sulfate as the dissolution medium, and the rotate speed was 100 r. rain-1. The dissolution rate of 2 active components of ZDCP were determined by HPLC, and the accumulative dissolution was also calculated. RESULTS The accumulated dissolution rates of oleanolic acid, berberine hydrochloride in ZDCP were 71.94%, 86.44% respectively. CONCLUSION The method is accurate, reliable and reproducible, and applicable for the determination of the dissolution rate of ZDCP. It can be used for the estimation of quality of ZDCP.