阿普唑仑缓释片的处方筛选及体外释放度考察

目的:优选阿普唑仑缓释片处方,并对制剂进行体外释放度考察。方法:以羟丙基甲基纤维素(HPMC)、乙基纤维素、乳糖在处方中的用量百分比及HPMC的规格为考察因素,体外释放度为考察指标,经正交试验优化缓释片最佳处方,并对优化后处方所制制剂进行体外释放度考察。结果:优化处方中HPMC、乙基纤维素和乳糖用量百分比分别为30%、4%、15%,HPMC的规格为K4M;优化后所制制剂可持续释药24h,释药特性符合Higuchi方程。结论:所筛选的阿普唑仑缓释片处方合理并具有体外缓释性。

Optimization of the Formulation of Alprazolam Sustained - release Tablet and Study on Its Release in Vitro Characteristics

OBJECTIVE： To optimize the formulation of alprazolam sustained - release tablet and investigate its in vitro release profile. METHODS： Orthogonal experiment was carried out to optimize the formulation of alprazolam sustained- release tablet with the matching percentages of hydroxypropyl methyl cellulose （HPMC）, ethyl cellulose and lactose and the specification of the HPMC as factors and with the in vitro release rate as index. The in vitro release rate of the optimized preparation was investigated as well. RESULTS： The optimal formulation of alprazolam sustained - release tablet as follows： the matching percentages of HPMC, ethyl cellulose and lactose were 30%, 4% and 15%, respectively, and the specification of the HPMC was K4M. The alprazolam sustained - release tablet prepared in this optimized formulation achieved a sustained release of 24 h with its release profile in line with the Higuchi equation. CONCLUSION ： The optimized alprazolam sustained - release tablet is reasonable in formulation and characterized by sustained release.