复方苦豆子栓剂体外溶出度的测定及意义

Determination and Significance on the Dissolution Rate in Vitro of Co.Sophora Alopecuroides Suppository

目的:制备复方苦豆子栓剂并测定其体外溶出度。方法:以甘油明胶作为基质,制备复方苦豆子栓剂,并依据《中国药典》2005年版溶出度测定法项下第二法的规定,测定其溶出度。结果:按Weibull分布模型求得Td,m参数,3个批号栓剂溶出度参数差异均无统计学意义(P>0.05)。结论:该栓剂处方设计简单可行,质量可靠。

Objective：To prepare the compound sophora alopecuroides suppository and determine its dissolution rate in vitro. Methods：Glycerin-gelatin was used as the matrix to prepare the compound sophora alopecuroides suppository and to determine its dissolution rate according to the second item of regulations for determination method of dissolution rate in Chinese Pharmacopoeia（2005 ）. Results：The parameters of Td and m were obtained by Weibull distributed model and there was no significant difference in the suppository dissolution parameter of three batches （ P 〉 0 05 ）. Conclusion：The prescription of the suppository is easy and feasible in design and reliable in quality.