基于多元数据分析的固体分散体粉体学性质及其与重结晶过程中相对结晶度的相关性研究

Study on the Powder Properties of Solid Dispersions and the Correlation Between the Powder Properties and Relative Crystallinity During Recrystallization Based on Multivariate Statistical Analysis

关键词:  固体分散体  粉体学性质  相对结晶度  相关性

Key words:  solid dispersion  powder properties  relative crystallinity  correlation

摘要:

目的 研究固体分散体(solid dispersion，SD)粉体学性质与SD重结晶过程中相对结晶度(relative crystallinity，RC)的相关性。方法 以穿心莲内酯作为模型药，聚乙烯吡咯烷酮、聚乙二醇8000、泊洛沙姆188、Soluplus^®为载体材料，采用3种制备工艺获得了12种穿心莲内酯SD粉体，测定了SD的粉体学性质，并通过主成分分析法、偏最小二乘法等数据分析手段，研究SD粉体学性质与SD重结晶过程中RC的相关性。结果 通过偏最小二乘法成功建立了SD粉体学性质与RC之间的相关性模型。其中，粒径参数D(0.5)的VIP值>1.2，说明SD粉体学性质中粉体粒径是影响SD重结晶的关键因素。结论 在实际工作中，可以通过不同的制备方法，或者通过调整选定制备方法的工艺参数，获得具有不同粒径参数的SD粉体，以提高SD的重结晶稳定性。

Abstract:

OBJECTIVE To evaluate the correlation between the solid dispersion(SD) powder properties and the relative crystallinity(RC) during SD recrystallization. METHODS Andrographolide was used as model drug, polyvinylpyrrolidone K30, polyethylene glycol 8000, Poloxam 188, Soluplus^® as carrier materials, 12 SD powders were prepared by three preparation processes, and then the SD powder properties were determined. Afterwards, the principle component analysis and partial least squares analysis(PLS) were used to evaluate the correlation between the SD powder properties and RC during SD recrystallization. RESULTS The correlation model was successfully established by partial least square method between the SD powder properties and the RC. The VIP value of particle size parameter D(0.5) was >1.2, which indicated that the particle size was the key factor affecting the recrystallization of SD powder. CONCLUSION In practical work, SD powder with different particle size parameters can be obtained by different preparation methods or by adjusting the process parameters of the selected preparation method, so as to improve the recrystallization stability of SD.