三七总皂苷透皮凝胶膏剂的制备和含量测定  

Preparation and Content Determination of Total Saponins from Panax notoginseng Transdermal Gel Ointments

作　　者：吴静澜[1] 郭璐玫[1] 龚艳[1] 张永萍[1] 肖时珍[2] 

机构地区：[1]贵阳中医学院,贵阳550002 [2]贵州师范大学中国南方喀斯特研究院,贵阳550001

出　　处：《中国实验方剂学杂志》2013年第7期20-23,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：贵阳市科技计划项目(筑科合同2011201大-3号);贵州省科技计划课题(黔科合SY字[2011]3087);贵州师范大学人文社会科学研究基地自主招标课题(KSTZB1101)

摘　　要：目的:优选三七总皂苷透皮凝胶膏剂的制备工艺,并建立其含量测定方法。方法:以凝胶膏剂样品的初黏力、外观、涂布性等为综合评价指标,通过正交试验优选凝胶膏剂的成型工艺;采用HPLC测定三七总皂苷的含量。结果:优化的基质处方为部分聚合的聚丙烯酸钠4 g,羧甲基纤维素钠1 g,高岭土3.5 g,甘羟铝0.18 g,甘油-丙二醇(2∶1)25 g,聚乙烯吡咯烷酮0.5 g,聚维酮0.5 g,聚乙烯醇0.25 g。HPLC测得三七皂苷R1在0.42～3.36μg线性关系良好(r=0.999 6);人参皂苷Rg1在4.82～38.56μg线性关系良好(r=0.999 4);人参皂苷Rb1在1.24～9.92μg线性关系良好(r=0.999 7)。结论:优选的凝胶膏剂制备工艺稳定可行;建立的HPLC操作简便、可靠,适用于该制剂的含量测定和质量控制。Objective： To optimize preparation technology of total saponins from Panax notoginseng transdermal gel ointments and establish its content determination method. Method： With adhesive power, appearance, coating properties, et al as comprehensive indexes, molding technology of total saponins from P. notoginseng gel ointments was optimized by orthogonal test. The content of total saponins from P. notoginseng was determined by HPLC. Result： The best formulation was as following： NP-700 and CMC （4：1 ） 5 g, kaolin 3.5 g,aluminium glycinate 0. 18 g, glycerin and propylene glycol （2： 1） 25 g, PVP-K90 0. 5 g, PVPP 0.5 g, PVA 0.25 g. The linear range of notoginsenoside R1 , ginsenoside Rgl and ginsenoside Rb1 were 0.42-3.36 μg （r = 0. 999 6） ,4.82-38.56 μg （ r = 0. 999 4 ）, 1.24-9.92 μg （ r = 0. 999 7 ）. Conclusion ： This optimized preparation technology of gel ointments was stable and practical. Established HPLC method was simple, reliable, and suitable for content determination and quality control of the preparation.

关 键 词：三七总皂苷 凝胶膏剂 正交试验 高效液相色谱 

分 类 号：R283.6[医药卫生—中药学]