黄芪总皂苷口腔粘附缓释片的处方筛选及体外释放度测定

Optimization of Excipient Prescription of Astragaloside Buccal Mucoadhesive Sustained-release Tablets and Determination of Its In-vitro Dissolution Rate

【目的】优化黄芪总皂苷口腔粘附缓释片制备处方。【方法】采用正交试验设计法,以羟丙甲纤维素、丙烯酸树脂E-100和木糖醇为辅料,以片剂硬度、膨胀度、体外粘附时间、体外粘附力因素综合优化处方,并测定优化处方的体外释放度。【结果】优化的处方组成为羟丙甲纤维素、丙烯酸树脂E-100、木糖醇,其质量比为2∶2∶0.2。【结论】按照优化处方制备的黄芪总皂苷口腔粘附缓释片具有理想的生物粘粘附力和缓释性。

Objective To optimize the prescription of astragaloside buccal mucoadhesive sustained-release tablets.Methods Orthogonal design was adopted.We optimized the prescription of astragaloside buccal mucoadhesive sustained-release tablets by using hypromellose,acrylic resin E-100 and xylitol as excipients,and with the hardness,swelling degree,and in-vitro bioadhesive capacity（including adhesive time and strength）as the examination indexes.The in-vitro dissolution rate of the optimized tablets was detected.Results The optimal excipient prescription consisted of hypromellose,acrylic resin E-100 and xylitol,in the mass ratio of 2 ∶ 2 ∶ 0.2.Conclusion Astragaloside buccal mucoadhesive sustained-release tablets prepared according to the optimal excipient prescription have satisfactory bioadhesive capacity and sustained-release capacity.