柿霜吡哌酸粉双层缓释口腔贴膜的制备及评价

Preparation and evaluation of dried persimmon icing and PPA Bilayer Sustained Release Oral Films

目的制备柿霜吡哌酸（PPA）粉双层缓释口腔贴膜,并对其进行质量评价。方法评价贴膜的膜外观、体外黏附力、溶解时间和口腔黏附时间,测定贴膜中PPA含量及贴膜的体外释放度,评价其体外释药行为。结果口腔贴膜的体外黏附力为137 g/cm2,溶解时间为22.74 min,口腔黏附时间为23.59 min。含量测定结果显示,PPA量在0.18~0.54 mg/mL之间有良好的线性关系（r=0.9965）,回收率为100.54%,RSD=0.78%（n=6）。体外释药行为符合一级动力学方程。结论柿霜PPA粉双层缓释口腔贴膜处方及制备工艺合理可行,质量符合要求。

Objective To prepare and evaluate persimmon icing and PPA Bilayer Sustained Release Oral Films. Methods The formulation of Bilayer Sustained Release Oral Films of film appearance, adhesion, dissolution time and the oral cavity retention time were evaluated. The methods to determine the in vitro release rate of the oral films and to evaluate its release behavior in vitro were investigated. Results The average adhesion was 137 g/cm2, the mean dissolution time was 22.74 min, the oral cavity retention time was 23.59 min. The linear range of PPA were 0.18-0.54 mg/mL （r=0.9965）. The average recovery rate was 100.54%, RSD=O.78%（n=6）. In-vitro release was fitted to first-order kinet- ic equation. Conclusion The preparation technique of persimmon icing and PPA Bilayer Sustained Release Oral Films is reasonable and practicable. Quality of the films can meet the requirement.