目的 基于质量源于设计（QbD）理念对黄槐片进行成型工艺研究，并对颗粒进行质量控制。方法 以黄槐提取物为主药，采用湿法制粒压片，通过单因素实验筛选辅料，考察片的成型率、片质量差异、硬度、脆碎度和崩解时限，从而确定黄槐片的最佳处方及制备工艺。采用物理指纹图谱法对黄槐颗粒各项物理质量属性指标进行综合表征，建立由9个指标（相对均齐度指数、颗粒间空隙率、卡尔指数、松密度、振实密度、干燥失重、吸湿性、豪斯纳比、休止角）构成的颗粒物理指纹图谱，评价不同批次颗粒的质量一致性并对其可压缩性进行分析。结果 黄槐片的最佳处方为黄槐颗粒0.25 g，7%交联羧甲纤维素钠、2%滑石粉，混匀。最佳工艺条件为16目筛制粒，60℃干燥1 h，18目筛整粒。5批黄槐颗粒物理指纹图谱相似度均高于0.983，5批颗粒参数指数均大于0.4，参数轮廓指数在4.82~5.70，良好可压性指数在4.44~5.25。结论 建立的黄槐片制备工艺、处方及中间体颗粒物理质量标准科学合理，工艺稳定可行，为中药复方制剂的研发提供新的思路。

Objective To study the prescription and preparation technology of Huanghuai Tablets and evaluate the physical quality of intermediate particles based on quality by design. Methods Using Huanghuai (Scutellaria baicalensis and Sophora japonica) extract as the main component, the single factor experiments were used to screen adjuvant, and the forming rate, quality difference, hardness, friability, and disintegration time of tablets were used as indicators to optimize the optimal preparation processing of Huanghuai Tablets by wet granulation process. Physical indicators of granules were characterized by using micromeritics evaluation method. The physical fingerprint of granules were constructed by nine indexes including relative homogeneity index, interparticle porosity, Carr index, bulk density, tapped density, loss on drying, hygroscopicity, Hausner ratio, and angle of repose. The granules physical fingerprint is of great importance to evaluate the quality consistency of different batches of Huanghuai granules and analyze the compressibility of the granules. Results The optimum formula was Huanghuai granule 0.25 g, 7% croscarmellose sodium, and 2% talc powder. The optimum conditions were as follows:granulated with 16 mesh sieve, dried at 60℃ for 1 h, and unified with 18 mesh screen. The similarity of the physical fingerprint of five batches of Huanghuai granules was higher than 0.983, the parameters of five batches of particle parameters were all greater than 0.4, and the parameter profile index was 4.82-5.70, and the good pressure index was from 4.44 to 5.25. Conclusion The prescription and preparation technology of Huanghuai Tablets and the physical quality of intermediate particles were scientific and reasonable, which can provide ideas and methods for the research and development of Chinese materia medica formula.

四川省千人计划项目（2013332）；成都大学教改项目（cdjgy2017010）