草乌甲素胶丸的体外溶出度考察

Study on the in vitro Dissolution of Bulleyaconitine A Capsules

目的：建立草乌甲素胶丸的溶出度测定方法。方法：采用小杯法,以p H 1.2的人工胃液（含0.25%十二烷基硫酸钠溶液）、p H 4.0醋酸盐缓冲液（含0.5%十二烷基硫酸钠溶液）、p H 6.8磷酸盐缓冲液（含0.5%十二烷基硫酸钠溶液）及水（含0.25%十二烷基硫酸钠溶液）为溶出介质,转速50 r·min-1,取样时间30 min测定溶出度,采用高效液相色谱法测定草乌甲素的溶出量,绘制溶出曲线。结果：草乌甲素胶丸批内批间的溶出度结果差异较小,15 min后样品的释放百分率趋于平稳。草乌甲素的检测浓度在2～20μg·ml-1（r=0.999 2）范围内呈良好的线性关系,在4不同溶出介质中的回收率均在99%以上。结论：该方法简便、准确,重复性好,可用于该胶丸的溶出度测定。

Objective： To establish a method for the in vitro dissolution of bulleyaconitine A capsules. Methods： A small glass method was adopted respectively with pH 1.2 artificial gastric solution（ containing 0.25% sodium lauryl sulfate）, pH 4.0 acetate buff- er, pH 6.8 phosphate buffer and water（ containing 0.5% or 0.25% sodium lauryl sulfate） as the medium at the rotating speed of 50 r · min - 1, and the sampling time was 30 min. The dissolution of bulleyaconitine A was determined by HPLC, and the dissolution curve was drawn. Results： The cumulative dissolution of bulleyaconitine A capsules showed no differences in and between the batches. The dissolution percentage of bulleyaconitine A capsules tended to be stable after 15 minutes. The assay displayed a good linearity over the concentration range of 2 -20 μg · ml - 1 （ r = 0.999 2） for buUeyaconitine A; the recovery in the four different dissolution medium was all above 99%. Conclusion： The method is simple, accurate and reproducible in the dissolution determination of bulleyaconitine A cap- sules.