通泰凝胶膏剂的基质处方筛选及制备工艺研究  

Study on Matrix Formulation Screening and Preparation Process of Tongtai Gel Paste

作　　者：邹曼 周艳 吴雪茹 吴超敏 翁佳燕 ZOU Man;ZHOU Yan;WU Xueru;WU Chaomin;WENG Jiayan(The Third Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510240 Guangdong,China)

机构地区：[1]广州中医药大学第三附属医院,广东广州510240

出　　处：《中药新药与临床药理》2021年第6期841-844,共4页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：广东省中医药局建设中医药强省立项资助科研课题(20191174)。

摘　　要：目的筛选通泰凝胶膏剂的基质处方,并对其制备工艺进行优化。方法以聚丙烯酸钠NP-700、甘羟铝、高岭土、酒石酸为影响因素,以凝胶膏剂的初黏力、持黏力、剥离强度、综合感官为评价指标,采用正交试验法对基质处方进行筛选;以搅拌频率、浸膏用量、交联时间、干燥时间为影响因素,采用均匀设计法对制备工艺进行优化。结果最优基质处方为聚丙烯酸钠NP-700250 g、甘羟铝15 g、高岭土300 g、酒石酸2 g,综合评分为97.5分;最优制备工艺为浸膏用量500 g、交联时间15 min、干燥时间3 h,综合评分为99.7分;加速定性试验和长期稳定性试验显示凝胶膏剂的稳定性均较好。结论所制备的通泰凝胶膏剂具有较好的黏性及内聚力,良好的皮肤追随性,制备工艺比较可靠,稳定性好。Objective To screen the matrix formulation of Tongtai gel paste and optimize its preparation process.Methods Taking sodium polyacrylate NP-700,glycerol,kaolin,and tartaric acid as the influencing factors,and the initial adhesion,holding adhesion,peeling strength,and comprehensive sensory of the gel ointment as the evaluation indicators,the orthogonal test method was used to carry out the matrix prescription screening.The stirring frequency,the amount of extract,cross-linking time,and drying time were taken as influencing factors in the uniform design method used for optimization of the preparation process.Results The optimal matrix formulation is sodium polyacrylate NP-700250 g,glycerol 15 g,kaolin 300 g,and tartaric acid 2 g,with a comprehensive score of 97.5;the optimal preparation process is 500 g extract and 15 min cross-linking time,drying time is 3 hours,and the comprehensive score is 99.7 points;accelerated qualitative test and long-term stability test show that the stability of gel ointment is good.Conclusion The prepared Tongtai gel ointment has good viscosity and cohesion,good skin followability,relatively reliable preparation process and good stability.

关 键 词：通泰凝胶膏剂 基质处方 制备工艺 正交试验 均匀设计 

分 类 号：R283.6[医药卫生—中药学]