二丙酸倍他米松微乳泡沫剂的体外透皮考察  

Investigation of Microemulsion Foam System for Transdermal Delivery of Betamethasone Dipropionate

作　　者：张福荣[1] 武余波[1] 罗华菲[1] 边琼[1] 王浩[1] 

机构地区：[1]中国医药工业研究总院药物制剂国家工程研究中心,上海201203

出　　处：《中国医药工业杂志》2017年第3期393-399,共7页Chinese Journal of Pharmaceuticals

基　　金：国家"重大新药创制"科技重大专项(2014ZX09507006-002)

摘　　要：针对二丙酸倍他米松微乳泡沫剂的体外透皮行为进行研究,对接收介质、皮肤模型进行筛选,完成了体外透皮HPLC分析方法的验证,并以此进行处方的初步筛选。结果表明,可采用异丙醇:pH 5.0磷酸盐缓冲液(20:80)为接受介质,猪皮为体外透皮模型;建立的色谱方法专属性强、重现性好、准确度高,可以满足体外透皮试验药物含量测定的需求。根据伪三元相图以及体外透皮试验结果,初步筛选微乳泡沫剂油相为中链甘油三酸酯。To evaluate the transdermal behavior ofbetamethasone dipropionate from the microemulsion foam for transdermal delivery, the release medium and species of excised skin were screened and a methodology validation of high performance liquid chromotogrophy （HPLC） for determination was completed. The results showed that isopropanol ： pH 5.0 phosphate butter （20 ： 80） was the suitable release medium and excised pig skin was selected as the percutaneous model. The established HPLC method was specific, repeateable and accurate, which could meet the requirements of drug determination in in vitro transdermal test. According to the pseudo-ternary phase diagrams and the results of in vitro transdermal test, medium chain triglyceride （MCT） was preliminarily confirmed as the suitable oil phase of microemulsion foam.

关 键 词：二丙酸倍他米松 微乳泡沫剂 体外透皮 

分 类 号：R944.9[医药卫生—药剂学]