基于流变学性质的辅料用量对中药凝胶贴膏成型质量影响的研究  

Effect of excipient dosage on modeling quality of gel plaster of traditional Chinese medicine based on rheological properties

作　　者：杨光[1] 朱森发 李文杰[1] 王优杰[2] 王建英[1] 赵立杰[2] 张宝军[1] 洪燕龙[1] YANG Guang;ZHU Senfa;LI Wenjie;WANG Youjie;WANG Jianying;ZHAO Lijie;ZHANG Baojun;HONG Yanlong(Shanghai Traditional Chinese Medicine Health Service Collaborative Innovation Center,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Innovative Research Institute of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学中医健康服务协同创新中心,上海201203 [2]上海中医药大学创新中药研究院,上海201203

出　　处：《上海中医药大学学报》2022年第1期75-84,共10页Academic Journal of Shanghai University of Traditional Chinese Medicine

基　　金：国家自然科学基金资助项目(81973490);上海市自然科学基金资助项目(18ZR1436600);上海市“科技创新行动计划”技术标准项目(20DZ2200900);上海市中医药事业发展三年行动计划项目[ZY(2018-2020)-CCCX-2001-03];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);上海市科技计划项目(21DZ2271000);中药制药过程新技术国家重点实验室开放基金计划项目(SKL2020Z0205)。

摘　　要：目的:研究中药凝胶贴膏辅料用量对凝胶膏体的流变学性质及制剂成型质量的影响,探索影响凝胶贴膏成型质量的关键流变学参数。方法:以腰突膏处方为模型药物,通过单因素实验,选择不同用量的聚丙烯酸钠NP700、甘羟铝、卡波姆、酒石酸,制备凝胶膏体。一部分膏体采用流变仪进行膏体的储能模量(G′)、损耗模量(G″)、蠕变柔量恢复率[J(t)%]等流变学指标评价;另一部分制备成贴膏,对贴膏的表面光滑度及残留、气泡及颗粒、初黏力等进行质量评价,同时对膏体的流变学指标与贴膏成型质量进行相关性分析。结果:(1)NP700主要通过影响膏体的G′ω=100、G″ω=0.1、J(t)%值影响凝胶贴膏的初黏力、反复揭贴性、触变性;(2)卡波姆主要通过影响膏体的G′ω=100、G″ω=0.1值影响凝胶贴膏的初黏力、反复揭贴性、触变性;(3)甘羟铝主要通过影响膏体的G″ω=0.1、J(t)%值影响凝胶贴膏的初黏力和触变性;(4)酒石酸主要通过影响膏体的G′ω=100影响凝胶贴膏的光滑度与残留、初黏力、反复揭贴性、触变性。其中,NP700和甘羟铝的用量对中药凝胶贴膏制剂质量影响较大。结论:不同辅料用量对凝胶贴膏膏体的流变学性质及贴膏的成型质量影响规律不同,可通过膏体的流变学指标检测,有目的地调节凝胶贴膏的辅料用量,从而调节凝胶贴膏的成型质量。Objective:To study the effect of excipient dosage on the rheological properties and preparation modeling quality of gel plaster of traditional Chinese medicine(TCM),and explore the key rheological indexes which affect the modeling quality of gel plaster.Methods:Taking the prescription of lumbar disc protrusion plaster as the model drug,through a single factor experiment,different dosages of sodium polyacrylate NP700,aluminum glycolate,carbomer and tartaric acid were selected to prepare the gel paste.One part of the pastes was used to test the rheological indexes including storage modulus(G’),loss modulus(G ") and creep recovery rate[J(t)%] by rheometer.The other part was prepared into the plaster,and the quality indexes of the plaster including surface smoothness and residual,bubble and particle,initial adhesion and so on were evaluated.Meanwhile,the correlation analysis between the rheological indexes of the paste and the modeling quality of the plaster was carried out.Results:①NP700 mainly affected the initial adhesion,repeated exposure and thixotropy of the gel plaster through affecting the values of G’;, G";and J(t)% of the paste.②Carbomer mainly affected the initial adhesion,repeated exposure and thixotropy of the gel plaster through affecting the values of G’;G ";of the paste.③Aluminum glycolate mainly affected the initial adhesion and thixotropy of the gel plaster through affecting the values of G";and J(t) % of the past.④Tartaric acid mainly affected the smoothness and residual,initial adhesion,repeated exposure and thixotropy of the gel plaster through affecting the value of G ’;of the paste.Among them,the dosage of NP700 and aluminum glycolate had greater influence on the modeling quality of gel plaster of TCM.Conclusion:Different excipient dosage has different effect laws on the rheological properties of the paste of gel plaster and the modeling quality of the plaster.The excipient dosage of gel plaster can be purposefully adjusted through detection of rheological indexes of the paste,s

关 键 词：中药凝胶贴膏 基质用量 单因素考察 流变学指标 

分 类 号：R283.6[医药卫生—中药学]