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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 determination of dissolution of abalone capsule. Methods: Using a small cup method, artificial gastric juice (containing 0.25% sodium dodecyl sulfate), pH 4.0 acetate buffer (containing 0.5% sodium lauryl sulfate solution), pH 6.8 phosphate buffer (containing 0.5% sodium dodecyl sulfate solution) and water (containing 0.25% sodium dodecyl sulfate solution) as the dissolution medium, speed 50 r · min-1, sampling time 30 min dissolution , Using high performance liquid chromatography to determine the dissolution rate of abamectin, and draw the dissolution curve. Results: There was no significant difference in the dissolution results between the two groups. The percentage release of the samples after 15 min tended to be stable. The concentration of abamectin in the range of 2 ~ 20μg · ml-1 (r = 0.999 2) showed a good linear relationship, and the recoveries in 4 different dissolution media were above 99%. Conclusion: The method is simple, accurate and reproducible. It can be used to determine the dissolution of the capsule.