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

作　　者：杨光 朱森发 田文秀 李文杰 鲜洁晨[3,4] 洪燕龙 YANG Guang;ZHU Sen-fa;TIAN Wen-xiu;LI Wen-jie;XIAN Jie-chen;HONG Yan-long(Shanghai Innovation Center of TCM Health Service,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Nanchang Hongdu Hospital of Traditional Chinese Medicine,Shanghai 201203,China;Innovative Research Institute of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine,Ministry of Education,Nanchang 330006,China)

机构地区：[1]上海中医药大学上海中医健康服务协同创新中心,上海201203 [2]南昌市洪都中医院,上海201203 [3]上海中医药大学创新中药研究院,上海201203 [4]中药现代制剂技术教育部工程研究中心,江西南昌330006

出　　处：《中国中药杂志》2024年第3期634-643,共10页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(81973490);上海市“科技创新行动计划”技术标准项目(20DZ2200900);上海中医药慢性病防治与健康服务省部共建协同创新中心项目(2021科技02-37);上海市自然科学基金面上项目(23ZR1463500)。

摘　　要：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.

关 键 词：凝胶贴膏 特征物理性质 成型质量 旋转流变仪 

分 类 号：R283.6[医药卫生—中药学]