目的 探究水-醇双提工艺下中药复方粉末影响颗粒流动性的关键物性参数。方法 以水-醇双提工艺下杏贝止咳颗粒（Xingbei Zhike Keli，XZK）、桂枝茯苓胶囊（Guizhi Fuling Jiaonang，GFJ）以及参乌益肾片（Shenwu Yishen Pian，SYP）3个中药复方品种的制粒前粉末与制粒后颗粒为研究对象，采用多元统计分析方法，绘制粉末物理指纹图谱，结合Pearson相关系数评价粉末质量一致性；采用主成分分析（principal component analysis，PCA）结合因子分析评价颗粒流动性；并构建以松装密度（D_a）、振实密度（D_c）、休止角（α）、豪斯纳比（IH）、粒径＜50µm百分比（Pf）、均匀性（HG）、均齐度（UN）、粒径（D₁₀、D₅₀、D₆₀、D₉₀）、分布宽度（span）、分布范围（width）、比表面积（SSA）、孔隙率（I_e）、卡尔指数（IC）、含水量（HR）、吸湿率（H）为自变量、以颗粒流动性总因子得分（TFS）为因变量的正交偏最小二乘法-判别分析（orthogonal partial least-squares discrimination analysis，OPLS-DA）模型，用以辨识粉末关键物性参数。结果 分别构建了3个品种各15批粉末的物理指纹图谱，结合Pearson相关系数结果显示3个品种粉末质量一致性良好，其中SYP颗粒优于XZK颗粒再优于GFJ颗粒；计算得颗粒流动性TFS，整体来看流动性XZK颗粒优于SYP颗粒再优于GFJ颗粒；OPLS-DA模型优化后辨识出H、UN、SSA、HR为影响颗粒流动性的关键物性参数，置换检验结果表明模型有效可靠。结论 基于OPLS-DA模型辨识出影响水-醇双提工艺下中药复方粉末影响颗粒流动性的关键物性参数为H、UN、SSA、HR。

Objective To explore the key physical parameters of the traditional Chinese medicine compound powder affecting the particle fluidity under the water alcohol double extraction process. Methods The pre granulation powder and post granulation pellet of three Chinese herbal formula varieties, Xingbei Zhike Keli (杏贝止咳颗粒, XZK), Guizhi Fuling Jiaonang (桂枝茯苓胶囊, GFJ), and Shenwu Yishen Pian (参乌益肾片, SYP) under the water alcohol double extraction process were used as the research objects, and the physical fingerprints of the powders were plotted by multivariate statistical analysis, combined with Pearson correlation coefficients to evaluate the consistency of powder quality; Particle mobility was evaluated by principal component analysis (PCA) combined with factor analysis; And based on the bulk density (D_a), tapped density (D_c), angle of repose (α), Hausner’s ratio (IH), particle size < 50 µm percentage (Pf), homogeneity (HG), uniformity (UN), particle size (D₁₀, D₅₀, D₆₀, D₉₀), width of distribution (span), range of distribution (width), specific surface area (SSA), porosity (I_e), Carr index (IC), moisture content (HR), moisture uptake (H) as independent variables, and total factor score of particle mobility (TFS) as dependent variables, the orthogonal partial least-squares discriminant analysis (OPLS-DA) model was constructed to identify the key physical parameters of the powder. Results The physical fingerprints of 15 batches of powders from each of the three varieties were constructed separately, and combined with Pearson’s correlation coefficient results showed good consistency in powder quality among the three varieties, in which SYP particles were superior to XZK particles and then superior to GFJ particles; The particle fluidity TFS was calculated, and overall the fluidity XZK particles were better than SYP particles and again better than GFJ particles; H, UN, SSA and HR were identified as the critical material parameters affecting the particle mobility after optimization by OPLS-DA model, and permutation test results indicated that the model was valid and reliable. Conclusion The critical property parameters affecting the particle mobility of TCM compound powders under the water alcohol dual extraction process were identified as H, UN, SSA, HR based on the OPLS-DA model.

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接制造关键技术研究（CGJBGS2101）