摘要
Abstract
OBJECTIVE:To prepare Ambroxol hydrochloride hydrogel patch and study its transdermal permeability in vitro. METHODS:Polyvinyl alcohol (PVA),aluminum glycinate and polyacrylic acid sodium (PAAS) were used as excipients to pre-pare Ambroxol hydrochloride hydrogel patch. Based on single factor experiments,using appearance and property,initial bonding strength,endurance bonding strength and peel strength as indexes,Box-Behnken response methodology was used to optimize the amount of PVA,aluminum glycinate and PAAS. Validation test was also conducted. The transdermal permeability in vitro of pre-pared hydrogel patch was investigated by Franz diffusion cells. RESULTS:The optimal prescription was as follows as PAAS 2.35 g,aluminum glycinate 0.1 g,PVA 1.0 g. Comprehensive score of 3 batches of hydrogel patch were 9.4,9.5,9.7,respectively;rel-ative errors were 2.08%,1.04%,1.04% compared with the predicted values. Within 24 hours,the transdermal rate of ambroxol hydrochloride was 9.472 μg/(cm2·h),which was up to zero-order kinetic model(r=0.994). CONCLUSIONS:Hydrogel patch for-mula is reasonable and shows good transdermal properties. Its transdermal absorption meets zero-order kinetic process.关键词
盐酸氨溴索/凝胶膏剂/Box-Behnken响应面法/体外透皮Key words
Ambroxol hydrochloride/Hydrogel patch/Box-Behnken response methodology/Transdermal permeability in vitro分类
医药卫生
