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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 formulation (molding) process of Qishen Jiangu granule. Methods: Taking the moisture absorption rate, forming rate, dissolubility, angle of repose and ease of granulation as evaluation indexes, the single factor experiments were conducted to investigate the influence of the types and amounts of auxiliary materials, the ratio of mixed auxiliaries, the concentration of wetting agent and the dosage. Orthogonal test method to further optimize the preparation process conditions. Results: The optimum conditions for the preparation of Qishenjiangyu granule were as follows: the extract powder and excipient (dextrin: lactose = 2: 1) were uniformly mixed in the ratio of 4: 1, stevia supplemented with 1% Wetting agent, wetting agent dosage and the total amount of extract 30%. CONCLUSION: The prepared granules have good fluidity, moisture absorption rate, forming rate, dissolvability and angle of repose, all of which meet the requirements. It provides a scientific experimental basis for the determination of the technological conditions of granulation of Qiguang Jiangu Granules.