非诺贝特缓释微球片体内外相关性评价  

Evaluation of in vitro-in vivo correlation of fenofibrate sustained-release microspheres tablets

作　　者：梅康康[1] 胡容峰[1] 马凤余[1] 张珂[1] 苏丹[1] 邹爱峰[1] 

机构地区：[1]安徽中医学院药学院

出　　处：《中国医院药学杂志》2008年第12期975-978,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:用脱卷积法进行自制非诺贝特缓释微球片体内外相关性的评价。方法:以市售微粒化非诺贝特胶囊剂的大鼠体内血药浓度数据为权函数,根据自制非诺贝特缓释微球片制剂大鼠体内血药浓度数据,采用脱卷积法,将不同时间点的体内吸收分数与体外累计释放百分数做线性回归,考察体内外相关性。结果:采用脱卷积法计算体外累计释放百分数和体内吸收分数相关系数较好(r=0.9225),相关性方程为Y=0.4642R+42.044。结论:脱卷积法适用于非诺贝特缓释微球片的体内外相关性研究。OBJECTIVE To evaluate the in vitro-in vivo correlation of self-designed tablets of fenofibrate sustained-release microspheres using deconvolution method. METHODS The characteristics of in vivo release were calculated by deconvolation method using the data of plasma concentration of self-designed sustained-release fenofibrate formulation in rats,in which the in vivo results of micronized fenofibrate capsule solution after oral administrated to rats were used as weight function. The in vitro-in vivo correlation was screened by comparing the linear regressive equations between the absorption percentage in vivo and the accumulate dissolution percentage in vitro. RESULTS The good correlation coefficient（r= 0. 922 5） could be abtained between the absorption percentage in vivo and accumulation dissolution percentage in vitro by deconvolution method, the equation was Y = 0. 464 2R ＋ 42. 044. CONCLUSION The deconvolution method exhibits advantage in evaluation of in vitro-in vivo correlation for tablets of fenofibrate sustained-release microspheres.

关 键 词：非诺贝特 缓释微球片 脱卷积法 体内外相关性 

分 类 号：R943[医药卫生—药剂学]