目的 基于质量源于设计（QbD）理念对祛寒逐风颗粒的制备工艺进行研究，并对颗粒剂进行物理指纹图谱评价。方法 以干浸膏粉为主药，选取成型率、休止角、吸湿率、溶化率为评价指标，采用Box-Behnken设计-响应面法优选工艺参数，运用D-最优混料设计优选辅料种类。以二级物理指标相对均齐度指数、松密度、振实密度、水分、吸湿率、豪斯纳比、休止角为评价指标，建立物理指纹图谱，评价不同批次颗粒剂质量的一致性。结果 祛寒逐风颗粒的制备工艺为以可溶性淀粉-糊精（3∶2）为辅料，药辅比1∶2，30 mL 80%乙醇为润湿剂。5批颗粒的物理指纹图谱相似度大于0.99。结论 祛寒逐风颗粒制备工艺稳定可行，物理指纹图谱科学合理，为中药制剂制备工艺研究提供新的方向。

Objective To study the prescription and preparation technology of Quhan Zhufeng Granules (QZG, 祛寒逐风颗粒) and evaluate its physical fingerprint based on quality by design. Methods Using dry extract powder as the main component. The evaluation indicators were granule molding ratio, dissolubility, hygroscopicity and angle of repose. The Box-Behnken design response surface method was used to investigate the particle forming process parameters and the D-optimal mixture design was used to investigate the type of excipients. The physical fingerprint of granules was constructed by relative homogeneity index, bulk density, tap density, moisture, hygroscopicity, hausner ratio and angle of repose. Results The optimum conditions were as follows:Using soluble starch and dextrin (3:2) as the compound excipient, the dosage ratio of dry extract powder to compound excipient was 1:2, the amount of wetting agent (80% ethanol) was 30 mL. The similarity of the physical fingerprint of five batches of QZG was higher than 0.99. Conclusion The preparation process of QZG was stable and feasible, and the physical fingerprint was scientific and reasonable, which provides a new direction for the preparation process of traditional Chinese medicine preparations.

R283.6

2015年度中医药行业科研专项（201507001-06）；甘肃省中医药科研项目（GZK-2019-1）