复方半边莲滴丸制备工艺优化

Optimization on the Preparation Process of Compound Lobelia Dropping Pills

考察影响复方半边莲滴丸制备工艺的各因素,确定复方半边莲滴丸最佳制备工艺条件。在单因素考察的基础上,以滴丸的外观、重量差异、溶散时限为考察指标,采用正交试验设计对影响复方半边莲滴丸成型工艺的药物与基质比、冷凝介质温度、滴速等因素进行考察,优选复方半边莲滴丸的制备工艺。结果表明,最佳成型工艺为:以液状石蜡为冷凝介质,干浸膏与基质比1∶2,基质与基质比1∶4,药液温度70℃,冷凝介质温度5℃,滴速40滴/min,该工艺制备的滴丸外观圆整度良好,硬度较好,色泽均一。复方半边莲滴丸优选的制备工艺简单、可行、重现性好。

The factors which affected the preparation of compound lobelia dropping pills and establish the optimal preparation process were studied based on single factor test. Appearance,weight difference and dissolution time were used as comprehensive evaluation indicators to optimize the preparation process by orthogonal design,taking proportion of drug and substrate,the temperature of cooling medium and drops rate as factors. The optimal preparation conditions for the pills were as follows： condending medium was liquid paraffin wax,proportion of dry extract and substrate was 1：2,PEG4000： PEG6000 was1：4, the temperature of drug liquid and cooling medium were 70℃ and 5℃, respectively, drops rate was 40 d/ min.Dropping pills prepared by the optimal process have good appearance,appropriate hardness,uniformal color. The preparation process is simple,feasible and reproducible.