CAJ | 학술논문

目的：研究制备腹达康微丸并考察其体外释放度。方法：采用挤出滚圆法，制备微丸，以微丸收率为考察指标，优选挤出速率、滚圆速度和滚圆时间参数水平；以体外释药曲线为考察指标，采用单因素实验优化制剂处方及工艺条件。结果：工艺参数为挤出速度20Hz，滚圆速度20Hz，滚圆时间10min；速释微丸处方为40%主药，55%MCC(KG802),5%PVPP；缓释微丸处方为主药含量40%，MCC(国产)为赋形剂，20%尤特奇L100溶液包衣增重15%，其释药机制为符合Higuchi平面扩散释放过程。结论：挤出滚圆法制备腹达康速释和缓释微丸方法可行，且制剂具有良好的体外释药效果。
목적：연구제비복체강미환병고찰기체외석방도。방법：채용제출곤원법，제비미환，이미환수솔위고찰지표，우선제출속솔、곤원속도화곤원시간삼수수평；이체외석약곡선위고찰지표，채용단인소실험우화제제처방급공예조건。결과：공예삼수위제출속도20Hz，곤원속도20Hz，곤원시간10min；속석미환처방위40%주약，55%MCC(KG802),5%PVPP；완석미환처방위주약함량40%，MCC(국산)위부형제，20%우특기L100용액포의증중15%，기석약궤제위부합Higuchi평면확산석방과정。결론：제출곤원법제비복체강속석화완석미환방법가행，차제제구유량호적체외석약효과。
Objective:To research the preparation of Fudakang Pellets and investigate its in vitro releases. Methods:The pellets were prepared by extrusion-spheronization method. The extrusion velocity, spheronization velocity and spheronization time were optimized with the field of pellets as index. The formula of excipients was optimized by single-factor experiment with drug release curves as index. Results:The parameters were as follows:extrusion velocity of 20Hz, spheronization velocity of 20Hz, spheronization time of 10min. Quick release prescription was as follows:main drug 40%, MCC(KG802)55%, PVPP 5%. Sustained-release prescription was as follows:main drug 40%, MCC(domestic) as excipient, 20%eudragit L100 liquid, coating weight gain 15%. The drug release mechanism meet Higuchi planar diffusion release process. Conclusion:The extrusion-spheronization method is feasible for the preparation of Fudakang Pellets with good release characteristics.