摘要
目的对上市和本公司自制的非诺贝特缓释胶囊的体外释放度进行研究，为其质量控制提供参考。方法选用《中国药典》2005年版二部附录XD第一法，用紫外分光光度法测定非诺贝特的体外累积释放度，并对释药方程进行拟合。结果市和自制的非诺贝特缓释胶囊在1、4．7h的释放度均符合标示量的10％～30％，50％-75％和≥75％，释药机制是骨架溶蚀与药物扩散的协同作用。结论体外释放度作为药品质量控制的指标之一，既可进行体外的处方和工艺的筛选与优化，也可为临床合理用药提供依据。
Objective To investigate the release of Fenofibrate sustained-release capsules in vitro made by Yangpu HG Pharmaceutical Cooperation and those in the market, so as to provide reference for its quality control. Methods Release tests were carried out according to the first method in appendix X D of Chinese Pharmacopeia 2005 （ Volume II ）. The in vitro accumulated release data were determined by UV spectrophotometry and further fitted by release equations. Results Release of the capsules in 1, 4 and 7 h both in the market and made by Yangpu HG Pharmaceutical Cooperation were 10%- 30%, 50% ～ 75% and ≥75% of the labeled amount. Drug diffusion and skeleton erosion were the release mechanisms. Conclusion Release in vitro can be used as one of the index for drug quality control, It can optimize the formulation and technique as well as provide basis for rational clinical drug application.
出处
《今日药学》
CAS
2010年第4期34-36,共3页
Pharmacy Today
关键词
非诺贝特
缓释胶囊
释放度
fenofibrate
sustained-release capsules
release
