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目的优选肝清颗粒的制剂工艺。方法以制粒情况、成型率、溶化性、休止角和吸湿率为评价指标,采用正交试验法优选制剂工艺条件。结果肝清颗粒最佳制粒工艺条件为:浸膏粉和混合辅料(糖粉:糊精=2.5:1)按5.7:6.3比例混匀,以65%糖浆为粘合剂,粘合剂用量为混粉总量的40%。制备的成品颗粒评价指标均符合要求。结论优选的肝清颗粒制剂工艺合理可行,成本低,为进一步制剂研究和临床应用提供了试验依据。
Objective To optimize the preparation of liver clearance granules. Methods Granulation conditions, forming rate, dissolubility, angle of repose and moisture absorption rate were used as evaluation indexes. Orthogonal test was used to optimize preparation conditions. Results The optimum granulation conditions of Ganqing granule were as follows: extract powder and mixed excipient (powdered sugar: dextrin = 2.5: 1) were mixed according to the ratio of 5.7: 6.3, with 65% syrup as binder, 40% of the total amount of mixed powder. Preparation of finished particle evaluation indicators are in line with requirements. Conclusion The optimized preparation method of Heqing granule is reasonable and feasible with low cost, which provides the experimental basis for further formulation research and clinical application.