采用星点设计-响应面法优化姜黄素纳米混悬温敏性水凝胶的处方和制备工艺  

Optimization of Formulation and Preparation Technology of Curcumin Nanoscale Suspension Thermosensitive Hydrogel by Central Composite Design Response Surface Methodology

作　　者：李佳佳 宁偎锋 李磊 LI Jia-jia;NING Wei-feng;LI Lei(Shenyang University of Chemical Technology,Shenyang 110142,China)

机构地区：[1]沈阳化工大学制药与生物工程学院,辽宁沈阳110142

出　　处：《沈阳化工大学学报》2022年第5期403-411,共9页Journal of Shenyang University of Chemical Technology

基　　金：辽宁省教育厅一般项目(L2016023);辽宁省科技厅博士科研启动基金(20141083)。

摘　　要：以泊洛沙姆407、泊洛沙姆188以及羧甲基壳聚糖制备的空白凝胶为基质,结合用反溶剂法制得的姜黄素纳米混悬液,制备姜黄素纳米混悬温敏性水凝胶,并采用星点设计-响应面法优化其处方和制备工艺.以凝胶被模拟泪液稀释前后的相变温度t_(1)、t_(2)为因变量,拟合方程,分析方差以及比较分析预测值和实际值,寻找温敏性水凝胶制备的最佳工艺和处方.FT-IR、SEM、XRD、UV-Vis以及透析袋法被用于分析剂型制备的成功与否以及体外性能考察.研究结果表明:在泊洛沙姆407和泊洛沙姆188的质量分数比为5∶1,羧甲基壳聚糖的体积分数为14.5%,以及戊二醛体积分数为3%的条件下,制备的温敏性水凝胶的胶凝温度预测值和实测值的偏差在±1%以内,且该温敏性水凝胶在室温下呈流动态,并经模拟泪液稀释后为33℃,满足胶凝的基本要求.本研究为该制剂在临床的应用提供了一种新思路.Curcumin nano-suspension thermosensitive hydrogel was prepared with blank gel prepared by Poloxamer 407(P407),Poloxamer 188(P188)and carboxymethyl chitosan(CMC)as matrix,combined with curcumin nano-suspension prepared by anti-solvent method.The formulation and preparation process of curcumin nano-suspension were optimized by star point design-response surface method.Taking the phase transition temperatures t_(1) and t_(2) of gel before and after being diluted by simulated tears as dependent variables.The fitting equation,variance analysis and comparison of predicted and actual values were used to find the best process formula for the preparation of temperature sensitive hydrogels.FT-IR,SEM,XRD,UV-Vis and dialysis bag method were used to evaluate the success of preparation and in vitro performance.The results showed that when the mass fraction ratio of P407 to P188 was 5∶1,the volume fraction of CMC was 14.5%,and the volume fraction of GA was 3%,the deviation between the predicted and measured gelation temperature of the prepared thermosensitive hydrogel was within±1%,and it showed a dynamic flow at room temperature,and it was 33℃after diluted with simulated tears,which meets the basic requirements of gelling.This research provides a new idea for the clinical application of the preparation.

关 键 词：姜黄素 纳米混悬液 温敏性水凝胶 星点设计-响应面法 

分 类 号：TQ469[化学工程—制药化工]