中国医药指南
中國醫藥指南
중국의약지남
CHINA MEDICINE GUIDE
2015年
22期
4-5
,共2页
盐酸曲美他嗪%缓释%星点设计
鹽痠麯美他嗪%緩釋%星點設計
염산곡미타진%완석%성점설계
Trimetazidine dihydrochioride%Sustained-release%Central composite design
目的：制备盐酸曲美他嗪缓释微丸，并筛选最优处方。方法以体外释放度为考察指标，采用星点设计优化处方并验证。结果成功制备了盐酸曲美他嗪缓释微丸；得到缓释包衣的最优处方为：Eudragit RS100与Eudragit RL100的比例为8.15，包衣增重10.46%；验证实验证明最优处方工艺的重现性良好。结论采用星点设计-效应面法成功得到盐酸曲美他嗪缓释微丸的处方优化模型，实现了处方优化。
目的：製備鹽痠麯美他嗪緩釋微汍，併篩選最優處方。方法以體外釋放度為攷察指標，採用星點設計優化處方併驗證。結果成功製備瞭鹽痠麯美他嗪緩釋微汍；得到緩釋包衣的最優處方為：Eudragit RS100與Eudragit RL100的比例為8.15，包衣增重10.46%；驗證實驗證明最優處方工藝的重現性良好。結論採用星點設計-效應麵法成功得到鹽痠麯美他嗪緩釋微汍的處方優化模型，實現瞭處方優化。
목적：제비염산곡미타진완석미환，병사선최우처방。방법이체외석방도위고찰지표，채용성점설계우화처방병험증。결과성공제비료염산곡미타진완석미환；득도완석포의적최우처방위：Eudragit RS100여Eudragit RL100적비례위8.15，포의증중10.46%；험증실험증명최우처방공예적중현성량호。결론채용성점설계-효응면법성공득도염산곡미타진완석미환적처방우화모형，실현료처방우화。
Objective To prepare the sustained-release pellets of trimetazidine dihydrochioride and screen the optimal preparation. Methods The preparation factors of in vitro drug release behavior were studied through single-factor experiments. Central composition design was used to optimize the experiment design. The optimal preparation was veriifed by experiment. Results The trimetazidine dihydrochioride sustained-release pellets was successfully prepared. The optimal preparation was as follows: Eudragit RS100 and Eudragit RL100 are at the ratio of 4∶1; the coating level is 10.46%. The preparation technology was reproducible. Conclusion A reliable model is established using response surface methodology and implements the prescription optimization.
