透皮给药系统热熔压敏胶基质处方的优化与初步应用  

Optimization and Preliminary Application of Hot Melt Pressure Sensitive Adhesives for Transdermal Drug Delivery System

作　　者：马建芳[1] 罗华菲[1] 朱壮志[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》2012年第7期553-557,共5页Chinese Journal of Pharmaceuticals

基　　金：国家"重大新药创制"科技重大专项(2011ZX09501-001-03)

摘　　要：以贴剂的初黏力、持黏力、剥离强度、水蒸气透过率和药物释放性能为评价指标,优化热熔型压敏胶基质处方中热塑性弹性体(SIS)、增黏树脂(C5加氢石油树脂)及增塑剂(轻质液体石蜡)的用量。采用优化的基质处方制备了3批睾酮贴剂,结果测得初黏力为(6.22±0.28)N,持黏力为(7.80±0.35)h,剥离强度为(0.33±0.13)kN/m,水蒸气透过率为(4.70±0.52)g·m^(-2)·d^(-1),24h药物累积释放率为(97.1±1.83)%,贴剂中药物的释放行为遵循Higuchi方程。The amount of thermoplastic elastomer （SIS）, tackifying resin （C5 hydrogenated petroleum resin） and plasticizer （light liquid paraffin） in hot melt pressure sensitive adhesives （HMPSA） were optimized with the initial tack force, cohesive strength, peeling strength, water vapor transmission and drug release behavior of the blank patches as the indexes. Three batches of testosterone patches with the optimal HMPSA were prepared. The results showed that the initial tack force, cohesive strength, peeling strength, water vapor transmission and cumulative release at 24 h were （6.22±0.28）N, （7.80±0.35） h, （0.33i±0.13） kN/m, （4.70±0.52） g^（-2）·d^（-1） and （97.1±1.83） %, respectively. The drug release behavior fitted to Higuchi equation.

关 键 词：热熔型压敏胶 睾酮 贴剂 优化 制备 

分 类 号：R944.9[医药卫生—药剂学]