中药新药与临床药理2026，Vol.37Issue(2)：332-342,11.DOI:10.19378/j.issn.1003-9783.2026.02.015
化浊散结除痹颗粒的制备工艺优化研究
Study on the Optimization of Preparation Technology for Huazhuo Sanjie Chubi Granules
摘要
Abstract
Objective To optimize the preparation technology of Huazhuo Sanjie Chubi Granules.Methods An ultra-performance liquid chromatography(UPLC)method was established for the simultaneous determination of multiple components in the compound formula.The transfer rates of neoastilbin,isoastilbin,neoisoastilbin,astilbin,and berberine hydrochloride,along with the extract yield,were used as evaluation criteria.The effects of extraction time,water addition volume,and extraction frequency on the extraction process of Huazhuo Sanjie Chubi Granules were investigated through single-factor tests combined with an orthogonal test.The optimal forming process was selected by evaluating the angle of repose,screening excipients,and conducting process validation.The finalized process was further verified through pilot-scale production.Results The optimized preparation process for Huazhuo Sanjie Chubi Granules was as follows:extract the herbal pieces by heated reflax twice,first with 12 times the amount of water for 1.5 hours,then again with 12 times the amount of water for 1.0 hour.Combine the decoctions and concentrate under reduced pressure to a density of 1.07-1.08 g·cm³(65-75℃).Add 5％maltodextrin and perform spray drying(inlet temperature 175-185℃,outlet temperature 90-100℃).Add 0.3％silicon dioxide,0.1％magnesium stearate(based on the weight of dry extract powder),and an appropriate amount of maltodextrin.Mix uniformly and prepare granules via dry granulation,followed by particle sizing and packaging.Three batches prepared during the pilot-scale production showed satisfactory performance across all evaluation criteria,with minimal inter-batch variation.Conclusion The optimized preparation technology for Huazhuo Sanjie Chubi Granules is stable and reliable,providing a research foundation for the process standardization of this granule formulation.关键词
化浊散结除痹颗粒/超高效液相色谱/正交试验/制备工艺优化/单因素试验/工艺标准化Key words
Huazhuo Sanjie Chubi Granules/UPLC/orthogonal test/preparation process optimization/single-factor test/process standardization分类
医药卫生引用本文复制引用
王美玲,郭洁梅,彭斯伟,张英杰,肖艳,杨瑞芳,陈冰燕,杨帆,陈鹏,苏友新..化浊散结除痹颗粒的制备工艺优化研究[J].中药新药与临床药理,2026,37(2):332-342,11.基金项目
国家重点研发计划"中医药现代化"重点专项(2022YFC3501200,2022YFC3501205) （2022YFC3501200,2022YFC3501205）
国家自然科学基金项目(82474326) （82474326）
国家中医药管理局2021年岐黄学者支持项目(国中医药人教函[2022]6号) （国中医药人教函[2022]6号）
福建省教育厅、福建省工信厅2023年技术创新重点攻关及产业化项目(2023XQ013) （2023XQ013）
福建省省级财政专项(X20220008-财政专项). （X20220008-财政专项）
