基于均匀设计法优化活血止痛凝胶膏剂处方工艺研究  

Optimization of Formulation Process of Huoxue Zhitong Gel Paste Based on Uniform Design Method

作　　者：刘会芳[1] 王振 张学顺[2] Liu Huifang;Wang Zhen;Zhang Xueshun(Department of Pharmacy,Jining Hospital of Traditional Chinese Medicine,Jining,272100,China;Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan,250014,China)

机构地区：[1]济宁市中医院药剂科,山东济宁272100 [2]山东中医药大学附属医院,山东济南250014

出　　处：《成都中医药大学学报》2022年第3期43-48,共6页Journal of Chengdu University of Traditional Chinese Medicine

基　　金：山东省中医药科技发展计划项目(2019-0740);济宁市重点研发计划项目(2020YXNS048)。

摘　　要：目的:为解决我院经典名方“渗透二号外用剂”临床应用中用量不统一、易污染衣物、临床疗效不稳定等问题,将其制备成活血止痛凝胶膏,以提高临床适应性。方法:采用均匀设计法,以初黏力、持黏力、剥离强度、膜残留为考察指标,优化活血止痛凝胶膏处方工艺,确定其处方组成。结果:采用均匀设计法确定其最佳配比为药液20 g,薄荷脑0.2 g,明胶3 g,高岭土1 g,二氧化钛0.25 g,依地酸二钠(EDTA-2Na)0.2 g,酒石酸0.9 g,氮酮0.5 g,羟苯甲酯0.5 g,NP-700聚丙酸部分中和物2 g,聚乙烯醇(PVA)6 g,羧甲基纤维素钠(CMC-Na)10 g,甘羟铝0.18 g,甘油23 g,纯化水32.27 g。结论:在均匀设计法确定的处方条件下制备出的活血止痛凝胶膏性质稳定,其初黏力、持黏力、剥离强度、膜残留均符合试验要求。Objective:In order to solve the problems such as the varies dosage,contamination clothing and relatively poor clinical efficacy in the clinical application of our hospital’s classic external prescription Shentou Erhao,we make it to be Huoxue Zhitong gel paste to improve its clinical adaptability.Methods:Uniform design method was used to optimize the formulation process of Huoxue Zhitong gel paste and determine its composition,using the initial adhesion,holding adhesion,peel strength and membrane residue as the indexes.Results:The best prescription is:extract 20 g;menthol 0.2 g;gelatin 3 g;kaolin 1 g;titania 0.25 g;EDTA 0.2 g;tartaric acid 0.9 g;azone 0.5 g;Methylparaben 0.5 g;NP-7002 g;PVA 6 g;CMC-Na 10 g;dihydroxyaluminum aminoacetate 0.18 g;glycerol 23 g;Purified water32.27 g.Conclusion:The properties of Huoxue Zhitong gel paste prepared by uniform design method were stable,and its initial adhesion,holding adhesion,peel strength and membrane residue all met the test requirements.

关 键 词：活血止痛凝胶膏剂 均匀设计法 处方工艺 初黏力 持黏力 剥离强度 膜残留 

分 类 号：R283.6[医药卫生—中药学] R287[医药卫生—中医学]