盐酸氟西汀口溶膜的制备与质量评价  

Preparation and quality evaluation of Fluoxetine Hydrochloride Orally Dissolving Films

作　　者：朱丽丹[1] 张丽妍[1] ZHU Lidan;ZHANG Liyan(Department of Pharmacy,the Third People′s Hospital of Dalian,Dalian 116033,China)

机构地区：[1]大连市第三人民医院药剂科,大连116033

出　　处：《西北药学杂志》2020年第6期889-893,共5页Northwest Pharmaceutical Journal

摘　　要：目的制备盐酸氟西汀口溶膜并评价其质量。方法通过实验筛选不同种类的成膜材料和增塑剂对盐酸氟西汀口溶膜成膜性能的影响,确定以羟丙基纤维素SL型(HPC SL)和甘油作为盐酸氟西汀口溶膜的处方变量因素,并以延展率和崩解时限作为评价指标,利用完全析因实验设计对盐酸氟西汀口溶膜的处方组成进行优化;通过扫描电镜观察盐酸氟西汀口溶膜的表观形态,比较了盐酸氟西汀口溶膜与盐酸氟西汀胶囊的体外药物溶出度,考察了盐酸氟西汀口溶膜在加速稳定性实验条件下6个月的稳定性。结果优化得到盐酸氟西汀口溶膜的最佳处方组成为:HPC SL质量浓度为100 mg·L^(-1),甘油质量浓度为15 mg·L^(-1),所制备的盐酸氟西汀口溶膜具有较强的韧性,崩解迅速,扫描电镜观察显示其呈半透明状,表面光洁,质地均匀,与市售盐酸氟西汀胶囊相比,盐酸氟西汀口溶膜中药物溶出度较快,在5 min内药物溶出度达到85%以上;盐酸氟西汀口溶膜在加速条件下放置6个月稳定性良好。结论该研究将盐酸氟西汀制备成口溶膜,处方工艺可行,稳定性良好,值得进一步研究。Objective To prepare Fluoxetine Hydrochloride Orally Dissolving Films(Flu-ODFs)and to evaluate their quality.Methods The effects of different types of film-forming materials and plasticizers on the film-forming properties of Flu-ODFs were investigated.It was determined that HPC SL was used as a film-forming material with glycerin as a plasticizer to prepare Flu-ODFs.The formulation of Flu-ODFs was optimized with full factorial experiment design considering the concentration of HPC SL,concentration of glycerin as independent variables and elongation rate,disintegration time as dependent variables.The apparent morphology of Flu-ODFs was observed by scanning electron microscope.The in vitro drug dissolution rates of Flu-ODFs and fluoxetine hydrochloride capsules were compared,and the stability of the Flu-ODFs under accelerated stability test conditions for 6 months was investigated.Results The optimal formulation of Flu-ODFs was as follows:the concentration of HPC SL was 100 mg·L-1 and the concentration of glycerin was 15 mg·L-1.The Flu-ODFs had good film forming properties and disintegrated quickly.The scanning electron microscopy showed that the film surface of Flu-ODFs was smooth and uniform.Compared with fluoxetine hydrochloride capsules,the dissolution of the drug in Flu-ODFs was rapid,and the drug dissolution rate reached more than 85%within 5 minutes.The Flu-ODFs had a good stability within 6 months under accelerated conditions.Conclusion Current study suggested that the Flu-ODFs had reasonable formulation design,feasible preparation process and good stability,which deserved further study.

关 键 词：盐酸氟西汀 口溶膜 完全析因实验设计 溶出速率 

分 类 号：R94[医药卫生—药剂学]