齐墩果酸骨架缓释片释药影响因素的考察

Studies on the Factors Influencing Oleanolic Acid Release from Matrix Tablets

目的对齐墩果酸缓释片的释药影响因素进行考察。方法采用羟丙甲基纤维素(HPMC)为缓释骨架材料;对影响释药因素,如HPMC的黏度与用量、粘合剂的种类、润湿剂的浓度、制备工艺等进行考察。结果HPMC的黏度与用量,粘合剂的种类对缓释片的释药有显著影响;润湿剂的浓度、片剂的硬度、制备工艺及溶出装置对缓释片的释药无明显影响。结论通过影响因素的考察,制备体外具有良好缓释效果的齐墩果酸缓释片,可进一步进行体内释药行为考察。

Objective To study the influence of different factors on the release properties of OLA from matrix tablets in vitro. Methods The sustained-release matrix tablets of OLA were prepared by using HPMC as the matrix materials. Factors （ such as the viscosity and amount of HPMC, adhesives, concentration of moistening agent, preparation technique ete） affecting the in vitro dissolution were observed. Results Both the concentration of moistening agent and viscosity , amount of HPMC had significant effect on the release of OLA. In contrast, the concentration of moistening agent and tablet hardness had no effect on drug-release rate. Conclusion The tablets have desirable sustain-release capability in vitro. The drug release in vivo will be carried on in the further test.