兰索拉唑肠溶片体内外相关性研究

Study on the Correlation between Dissolution in Vitro and Absorption in Vivo of Lansoprazole Enteric-coated Tablets

摘要: 目的考察兰索拉唑肠溶片的体外释放与在beagle犬体内吸收间的相关性。方法利用紫外分光光度法测定肠溶片体外释放度；利用高效液相色谱法测定beagle犬口服给药后的体内血药浓度；以Wagner-Nelson法计算其体内吸收分数，考察体内吸收与体外释放的相关性。结果兰索拉唑肠溶片的体内吸收分数fa与体外释放速率ft的关系为：fa= 0.812 2ft–9.874 6，r=0.956 8。结论兰索拉唑肠溶片的体外释放与在犬体内吸收相关性良好。

Abstract: OBJECTIVE To investigate the dissolution rate in vivo and bioavailability in beagle dogs of lansoprazole enteric-coated tablets, and to evaluate the correlations of the dissolution in vitro and absorption in vivo. METHODS The drug dissolution in vitro was measured by UV spectrophotometer. The plasma concentration in beagle dogs was measured by HPLC. The correlation of dissolution in vitro and bioavailability in vivo was studied by the Wagnner-Nelson method. RESULTS The relationship between the dissolution fraction ft and the absorption fraction fa was fa=0.8122ft-9.874 6, r=0.956 8. CONCLUSION The correlation between dissolution in vitro and absorption in vivo of lansoprazole enteric-coated tablets was good.