经典名方化肝煎胶囊剂的制备工艺研究

Studyon Preparation Technology of Huagan Decoction Capsule

目的:研究化肝煎胶囊的最佳制备工艺。方法:采用正交设计,以出膏率为指标,研究化肝煎胶囊的最佳提取工艺。湿法制粒过程中以颗粒得率、流动性、溶解性为综合指标优选化肝煎胶囊内容物颗粒的制备工艺。手工填充胶囊,对胶囊装量差异限度进行检查。结果:化肝煎胶囊提取工艺为加10倍量水提取3次,每次2 h;颗粒的制备工艺为以糊精为稀释剂与化肝煎干膏粉按1.5∶1的比例混合,水为润湿剂湿法制颗粒。结论:化肝煎胶囊的制备工艺方法稳定可靠,内容物颗粒符合颗粒剂的制备要求。

Objective:The optimum preparation technology of huaganjian granules was studied.Methods:The optimum extraction technology of huaganjian capsule was studied with orthogonal design and paste yield as index.In the wet granulation process,the comprehensive indexes of granule yield,fluidity and solubility were used to optimize the preparation technology of huaganjian capsules.Fill the capsule by hand and check the difference limit of capsule loading.Results:The extraction process of huagan decoction capsule was:add 10 times of water to extract twice,2 h each time.The preparation process of the granules was as follows:dextrin was used as diluent and liver decoction paste was mixed in a ratio of 1.5∶1,while water was used as wetting agent.Conclusion:The preparation method of huaganjian capsule is stable and reliable.