异叶青兰总黄酮片剂制备及处方优化

Preparation and Optimization of Formula of Total Flavonoids Tablets from Dracocephalum heterophyllum Benth.

目的设计并优化异叶青兰总黄酮片剂处方工艺。方法以药物浸膏、预交化淀粉、微晶纤维素湿法制粒,并借助辅料具有的功能复合特性,仅添加微量硬脂酸镁即可成片。再通过正交实验,以颗粒休止角、片剂硬度和崩解时间评价处方配比,获得最优处方工艺。结果最佳制粒处方比例为异叶青兰总黄酮浸膏-预交化淀粉-微晶纤维素(17∶25∶60),在颗粒中再添加1‰硬脂酸镁后制片。结论实验确立的最优处方工艺:处方简单、工艺易行;经中试实验验证,所制片剂质量考察合格,转化实际生产时可行性大,为消费者提供一种新的剂型选择。

Objective To design and optimize the prescription technology of total flavonoids tablets of Dracocephalum heterophyl- lum Benth. Methods Wet granulation by the multifunctional complex auxiliary materials,the Starch 1500 and PH 101, with extract,and then only microseale magnesium stearate was put to make tablets. Using the angle of repose, hardness,disintegration time as evaluation index, the optimized prescription ratio was obtained by orthogonal experiments. Results The best ratio of granules was total flavonoids extract of Dracocephalum heterophyllum Benth. - Starch 1500 - PH 101 （ 17：25：60） ,then put l‰ of magnesium stearate into the granules which were finally made into tablets. Conclusion The optimized prescription technology of the total flavonoids tablets of Dracocephalum heterophyllum Benth. was simple and applicable. It has good transformation feasibility for practical production which was certified by the qualified quality of tables in pilot tests, giving a new dosage form for consumers to choose,