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通过萘哌地尔在不同辅料中的平衡溶解度和伪三元相图筛选了空白自微乳化释药系统(SMEDDS)的组分,并继续用正交设计和单因素试验优化载萘哌地尔SMEDDS的处方。所得优化处方中萘哌地尔的溶解度显著高于水中溶解度,稀释后能形成平均粒径约23 nm的微小乳滴。体外释放试验表明,萘哌地尔SMEDDS及其混悬液在pH 6.8磷酸盐缓冲液中8 h累积释放率均低于20%;但在0.1 mol/L盐酸中,前者释放较快且完全。
Through the equilibrium solubility and pseudo-ternary phase diagram of naftopidil in different excipients, the components of blank self-microemulsifying drug delivery system (SMEDDS) were screened, and the orthogonal design and single factor experiments SMEDDS prescription. The optimal formulation obtained in the solubility of Naftopidil was significantly higher than the solubility in water, diluted to form tiny droplets with an average particle size of about 23 nm. In vitro release tests showed that the cumulative release rates of naftopidil SMEDDS and its suspension in pH 6.8 phosphate buffer for 8 h were less than 20%; however, in 0.1 mol / L hydrochloric acid, the former released faster and more completely.