贞丹浓缩丸的溶出度研究The Dissolution Study in Zhen Dan Concentrated Pill
朱志明,李勇,陈吉生
ZHU Zhiming,LI Yong,CHEN Jisheng
摘要(Abstract)：
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。
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·min~(-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.
关键词(KeyWords)：
贞丹浓缩丸;溶出度;小杯法;Weibull分布;高效液相色谱
Zhen Dan concentrated pill;dissolution rate;small Glass-method;Weibull distribution;HPLC
基金项目(Foundation):
作者(Author):
朱志明,李勇,陈吉生
ZHU Zhiming,LI Yong,CHEN Jisheng
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