五味金色分散片的提取工艺与制剂处方优选

Optimization of Extraction Process and Pharmaceutical Formulation of Wuwei Jinse Dispersible Tablets

目的:考察五味金色分散片的提取工艺与制剂处方,为五味金色丸的二次开发提供参考。方法:以总多酚、没食子酸含量和浸膏得率的综合评分为指标,采用正交试验考察提取时间、提取次数及料液比对五味金色分散片水提工艺的影响。以外观、分散均匀性、硬度为考察指标,采用单因素试验考察该分散片的辅料种类和用量。结果:最佳提取工艺为加10倍量水提取3次,每次90 min;总多酚得率6.29%,没食子酸质量398.37 mg,浸膏得率24.28%。以可压性淀粉和微晶纤维素为填充剂,交联羧甲基纤维素钠为崩解剂,微粉硅胶为润滑剂,在130 s内完全崩解并均匀分散。结论:优化的提取工艺有效成分提取率高,制剂处方设计合理,片剂质量稳定。

Objective： To optimize extraction process and pharmaceutical formulation of Wuwei Jinse dispersible tablets. Method： Taking composite score of contents of total polyphenols and gallic acid,dry extract rate as index,orthogonal test was adopted to investigate influence of extraction time,extraction times,the amount of water on water extraction process. With appearance, hardness and dispersion uniformity time as indexes,molding process of dispersible tablets was optimized by single factor tests. Result： Optimum extraction process consisted of adding 10-fold of waters,extracting 3 times,90 min for each time. Yield of total polyphenols was6. 29%,the content of gallic acid was 398. 37 mg,dry extract rate was 24. 28%. This dispersible tablets were made up of amylum pregelatinisatum,microcrystalline cellulose, croscarmellose sodium and micropowder silica gel, and it can be disintegrated completely and dispersed uniformly within 130 s. Conclusion： Optimized extracting process and pharmaceutical formulation are feasible and stable for industrial production of Wuwei Jinse dispersible tablets.