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目的:研究山楂叶混合粉的粉体学性质对其压缩成型性的影响。方法:以山楂叶50%乙醇提取的浸膏粉为模型药物,采用3种制备工艺,分别与2种辅料(微晶纤维素、可溶性淀粉)按质量比1∶0.5,1∶1,1∶2混合制备混合粉体,得18种山楂叶混合粉体。以抗张强度-压力回归方程中斜率为指标评价山楂叶混合粉的压缩成型性,运用逐步回归分析法研究山楂叶混合粉压缩成型性与粉体学性质之间的相关性。结果:山楂叶混合粉压缩成型性与粉体的振实密度(ρ_t),累计孔体积(PV),含水量(MC)及临界相对湿度(CRH)呈正相关,与粉体的50%通过粒径(D50),粒径距(Span),松散密度(ρ_b),Carr指数(CI),豪斯纳比率(HR)及比表面积(SSA)呈负相关。结论:ρ_b,ρ_t,Span,MC和CRH是影响山楂叶混合粉压缩成型性的关键粉体学性质。
Objective: To study the influence of powdering properties of hawthorn leaf mixture on its compression moldability. Methods: Extract powder extracted with 50% ethanol from hawthorn leaves was taken as model drug. Three kinds of preparation techniques were used respectively, with two kinds of excipients (microcrystalline cellulose and soluble starch) in the mass ratio of 1: 0.5,1: 1,1: 2 mixed preparation of mixed powder, 18 kinds of hawthorn leaves mixed powder. The compressive formability of hawthorn leaf mixed powder was evaluated by using the slope in the tensile strength-pressure regression equation as an index, and the correlation between compressibility and powder properties of hawthorn leaf mixed powder was studied by stepwise regression analysis. Results: Compressive formability of hawthorn leaf mixed powder was positively correlated with the tap density (ρ_t), cumulative pore volume (PV), water content (MC) and critical relative humidity (CRH) D50, Span, Loose density (ρ_b), Carr index (CI), Hausner ratio (HR) and specific surface area (SSA). Conclusion: ρ_b, ρ_t, Span, MC and CRH are the key powder properties that affect the compressibility of hawthorn leaf mixture.