丁香苦苷滴丸剂的工艺学研究

Study on Preparation Process of Syrigopicroside Dropping Pills

目的确定丁香苦苷滴丸的制备工艺。方法采用正交试验设计,从提取物与基质配比、料温、基质的配比等方面进行考察,以丸重变异系数、溶散时限、外观综合质量3个指标对试验结果进行方差分析,优选制剂工艺的最佳条件。结果根据试验确定最佳工艺为:以PEG4000∶PEG6000=4∶1为基质,丁香苦苷∶基质=1∶4,药液温度80℃。结论该工艺符合2005年版《中华人民共和国药典》对滴丸制剂的要求。

Objective To establish the optimum preparation process for Syrigopicroside Dropping Pills. Methods The preparation conditions, such as the proportion between the extracts and matrix, dripping temperature, the ratio of matrix, were studied with orthogonai test. The obtained results were tested by three indexes, such as the variation coefficient of weight of pill, time limit of dissolution and appearance of the dropping pills with analysis of variance. The preparation process was optimized. Results The optimal technical conditions were as follows： the ratio of PEG4000 and PEG6000 as matrix was 4 ：1, the ratio of syrigopicroside to matrix was 1 ： 4, and the dripping temperature was 80℃. Conclusion The preparation technology can meet the requirement for dripping pill specified in China Pharmacopeia （2005 Edition）.