复方苯巴比妥颗粒的制备

Preparation of Compound Phenobarbital Granules

目的：优选复方苯巴比妥颗粒的最佳处方。方法：用正交设计法，以每包颗粒的重量（A）、稀释剂（B）、粘合剂（C）为因素，按L9（3^4）设计实验，以颗粒吸湿性和苯巴比妥溶出度为评价指标，进行综合评分。结果：影响因素顺序为A〉B〉C，其中A、B对颗粒质量影响有显著意义。最佳处方为A1B3C3，即以乳糖为稀释剂、5％的羟丙甲纤维素为粘合剂、每包颗粒重3g。结论：优选的处方、工艺可行，制成的颗粒符合《中国药典》（2005年版）规定。

Objective： To optimize the best prescription of compound phenobarbital granules. Method： Orthogonal design was used,weight of every sack （A） ,diluents （B） ,adhesives （C） as factors,three levels were selected respectively, in accordance with orthogonal table L9 （3^4） ,bydroscopieity and dissolution were used as evaluation index to decide the best prescription. Result： Index A affects the quality most, then does index B, and index C affects least. A1 B3 C3 was the final prescription, lactose was used as diluent, HPMC （5%） was used as adhesives and sack weight was 3 g. Conclusion： The optimized formula and the preparation method are suitable. The preparation fits the standard of CP2005.