芪参健骨颗粒的制剂工艺研究

Pharmaceutical Study of Qishen Jiangu Granules

目的:优选芪参健骨颗粒的制剂(成型)工艺。方法:以吸湿率、成型率、溶化性、休止角和制粒难易程度为评价指标,单因素试验考察辅料的种类及用量、混合辅料的配比、润湿剂浓度及用量的影响;采用正交试验法进一步优选制剂工艺条件。结果:芪参健骨颗粒最佳制粒工艺条件为:浸膏粉与辅料(糊精∶乳糖=2∶1)按4∶1的比例混合均匀,加1%甜菊素,以90%乙醇为润湿剂,润湿剂用量为辅料与浸膏总量的30%。结论:优选的制剂工艺制备的成品颗粒流动性好,吸湿率、成型率、溶化性、休止角均符合要求,为芪参健骨颗粒制粒工艺条件的确定提供了科学的实验依据。

Objective：To optimize the preparation processes of Qishen jiangu Granules.Methods： Taking hygroscopicity,parallel experimentation,dissolvability,angle of repose,difficulty of granulating as assessing index,use single-factor experiment to research the influence of the type and contents of accessories,the proportion of mixed accessories,the concentration and volume of wetting agent.And the orthogonal experiment was used to further optimize the preparation process condition.Results：It was feasible that the combined excipients of Dextrin and lactose（in a ratio of 2∶ 1） was mixed with the extract powder in a ratio of 1∶ 4 and use 90% ethanol as wetting agent,add 30% of the total amount of the extract powder and add 1% the Glycoside Stevioside then granulated.Conclusion： The Qishen jiangu Granules had better fluidity,hygroscopicity,parallel experimentation,dissolvability,angle of repose all meet the requirements in ChP 2005.The results provide the scientific experimental basis for determining the technology conditions of Qishen jiangu Granules.