以卡波普为黏附材料的三七总皂苷生物黏附片的研制与体外评价

Preparation and in vitro Evaluation of Panax Notoginseng Saponines(PNS). Bioadhesive Tablets with carbopol

目的研制三七总皂苷生物黏附片,考察其体外释药动力学、对离体肠黏膜的黏附力。方法释放度测定方法按2005年版《中国药典》附录,采用显色法测定黏附片中三七总皂苷的释放,用零级释放、一级释放模型、H iguch i方程、Peppas方程对释放度进行动力学模拟,考察药物释放机制。以自制的黏附力测试装置测定生物黏附片对兔肠黏膜的黏附力。结果三七总皂苷生物黏附片体外释放符合设计要求,生物黏附片对于肠黏膜具有较大的黏附力。结论生物黏附片处方设计与制备工艺合理,达到了设计要求。

OBJECTIVE To prepare the Panax Notoginseng Saponines （PNS） bioadhesive tablets,and to study their release kinetics and bioadhesive tablets force to rabbit small intestine in vitro.METHODS Using rotating basket method,the dissolubility summation was determined with water as dissolution medium at speed 100 r·min^-1.The concentration of PNS was determined by coloration method.To study the release mechanism of PNS,Zero-class model,One-class model,Higuchi equation and Peppas equation was used to imitate the dissolution curve.A self-made apparatus was used to determine the adhesive force to rabbit small intestine.RESULTS The release behavior of the bioadhesive PNS tablets was in accord with the requirement of the design.CONCLUSION The bioadhesive tablets may meet the general requirements of the design.