目的 为加快实现中药生产过程中对中药配方颗粒的质量控制，从粉体物料属性出发，探究其对水提工艺下干法制粒的中药配方颗粒溶化性影响机制。方法 以60种中药配方颗粒及中间体混合粉为研究对象，通过对各品种混合粉粉体属性进行测定，建立粉体物性参数与颗粒溶化性关联模型。采用二维矩阵热点图对各品种间及物性指标间相似性进行分析，结合系统聚类分析对其进行归类，并运用多元统计方法初步筛选影响水提工艺下中药配方颗粒溶化性的关键因素。结果 各品种间粉体物性参数相关系数在-0.951～1.000，并按照各品种物理属性大致可以分为5类，结合变量投影响应值（variable importance for the projection，VIP）、自变量回归系数与方差膨胀因子（variance inflation factor，VIF）分析，最终筛选出其休止角（α）、含水量（HR）、吸湿性（H）与比表面积（SSA）4个指标为影响中药配方颗粒溶化性的关键物料属性（critical material attributes，CMAs）。结论 基于中药粉体物料属性与数据分析初步探寻影响水提条件下干法制粒的中药配方颗粒的溶化性机制，为后期工艺改进提供参考。

Objective In order to accelerate the quality control of traditional Chinese medicine (TCM) formula granules in the process of production, this experiment explored the influencing mechanism of powder material properties on the solubility of dry granule under water extraction technology. Methods A total of 60 kinds of TCM formula granules and intermediate powder were selected as the research object, and the correlation model between the physical parameters of the powder and the solubility of the particles was established by measuring the properties of the powder. Two-dimensional matrix heat map was used to analyze the similarity of the physical properties among different varieties, and the classification was combined with systematic cluster analysis. Multivariate statistical method was used to preliminarily screen the key factors affecting the solubility of TCM formula granules under the water extraction process.Results The correlation coefficients of the physical properties of powder among different varieties were between -0.951—1.000, and could be roughly divided into five categories according to its physical properties of each variety. Combined with the variable importance for the projection (VIP), the regression coefficient of independent variable and the variance inflation factor (VIF) analysis, Finally, the four indexes of angle of repose (α), water content (HR), hygroscopicity (H) and specific surface area (SSA) were selected as the critical material attributes (CMAs) affecting the solubility of TCM formula particles. Conclusion Based on material properties and data analysis of TCM powder, this study preliminarily explored the dissolution mechanism of TCM formula granules that affected dry granule under water extraction conditions, to provide a reference for the later process improvement.

R283.6

连云港市重大技术攻关“揭榜挂帅”项目：中药口服固体制剂智能化连续制造关键技术研究（CGJBGS2101）