基于制剂原料及中间体理化性质的中药凝胶贴膏成型规律研究

Molding law of traditional Chinese medicine gel plaster based on physicochemical properties of raw materials and intermediates

以中药饮片细粉为制剂原料,研究制剂原料及中间体理化性质与中药凝胶贴膏成型质量之间的相关性及其成型规律。选取48种中药复方为模型处方制备凝胶贴膏,使用旋转流变仪分别测定各处方膏体的储能模量(G′)、损耗模量(G″)、屈服应力(τ)、蠕变柔量[J(t)]等流变学参数。通过主观评分和客观评分对制备的中药凝胶贴膏进行质量评价,对各处方膏体的特征物理性质进行聚类、主成分等统计分析。以膏体的流变学性质对贴膏成型质量进行预测,贴膏7 d后成型质量预测准确率为83.72%,对30 d后的贴膏成型质量预测准确率达88.37%。当膏体G′、G″等参数较大且J(t)较小时,贴膏成型质量较好;当膏体的涂布点≥3时,膏体涂布困难。此外,当处方中含金属离子中药占比较高时,主要影响贴膏30 d成型质量,黏性较低。当处方中含酸性化学成分占比较高时,主要影响贴膏7 d成型质量,残留较多。研究结果提示基于膏体的流变学性质,可预测中药饮片细粉凝胶贴膏的成型质量,为中药凝胶贴膏的处方开发提供参考。

This paper aims to study the correlation between the physicochemical properties of raw materials and intermediates and the molding quality and law of traditional Chinese medicine(TCM)gel plaster by using TCM slices and powder as raw materials.48 TCM compounds are selected as model prescriptions to prepare gel plasters.The rotational rheometer is used to determine the rheological parameters of the plaster,including storage modulus(G′),loss modulus(G″),yield stress(τ),and creep compliance[J(t)].The molding quality of the prepared TCM gel plaster is evaluated by subjective and objective measures.Clustering and principal component analysis are conducted to evaluate the physical properties of the plaster.By measuring the rheological properties of the plaster,the molding quality of the TCM gel plaster can be predicted,with an accuracy of 83.72%after seven days of modeling and 88.37%after 30 days of modeling.When the parameters such as G′and G″of the plaster are large,and the[J(t)]is small,the molding quality of the plaster is better.When the plaster coating point is no less than 3,it is difficult to be coated.In addition,when the proportion of metal ions in the prescription is higher,the 30-day forming quality of the plaster is mainly affected,and the viscosity of the plaster is poor.If the prescription contains many acidic chemical components,the 7-day forming quality of the plaster is mainly affected,with many residuals.The results suggest that the rheological properties of the plaster can be used to predict the molding quality of TCM slice and powder gel plaster.It can provide a reference for the development of TCM gel plaster prescriptions.