混料设计优化感咳双清分散片的制备工艺

Using Mixture Design to Optimize Preparation Technology of Gankeshuangqing Dispersible Tablets

目的:考察感咳双清分散片的制备工艺及最优处方。方法:以崩解时间为考察指标,分别采用单因素试验及混料设计试验,对感咳双清分散片进行处方筛选及溶出度的测定。结果:感咳双清分散片的处方组成为:黄芩苷50%,穿心莲内酯12.5%,硫酸钙23.5%,微粉硅胶4.1%,L-HPC 11.3%;崩解时间为(47±1)s;溶出度测定表明本品溶出较感咳双清胶囊快。结论:该方法研制的感咳双清分散片处方合理,工艺可行,体现了分散片的特点。

Objective：To study the preparation process and the best prescription of Gankeshuangqing dispersible tablets. Methods： In order to select the prescription of Gankeshuangqing dispersible tablets and determine the dissolution, the disintegration time was used as index, single factor method and mixture design were used. Results ： The compositions of Gankeshuangqing dispersible tablets prescrip- tion were 50% baicalin, 12. 5% andrographolide, CaSO4 23.5% , micro-silica gel 4. 1%, and L-HPC 11.3%. The disintegration time was（47 ± 1 ） s. Dissolution tests showed that the dissolution rate of this product was higher than that of Gaukeshuangqing capsules. Conclusion：The developed Gankeshuangqing dispersible tablets embodies the characteristics of dispersible tablets. The pre- scription is reasonable and the technology is feasible.