摘要
目的对自制尼莫地平自乳化软胶囊进行Beagle犬体内药物动力学和生物等效性研究。方法采用HPLC法,对受试样品(自制尼莫地平自乳化软胶囊)及参比制剂(尼莫地平胶囊和尼莫地平胶丸)进行了Beagle犬生物利用度研究。采用3×3拉丁方交叉试验设计法、方差分析及双单侧检验对试验结果进行分析。结果受试制剂与参比制剂的生物利用度有显著差异。其单剂量给药实验结果表明:受试制剂相对于市售胶囊、胶丸的相对生物利用度分别为160.09%和139.13%。结论自制尼莫地平自乳化软胶囊对于市售胶囊、胶丸生物不等效。
Objective To study the bioequivalence and pharmacokinetics of nimodipine in self-emulsifying soft capsules(SESC), commercial capsules and commercial soft capsules in Beagle dogs. Methods The relative bioavailability study between the tested preparation(SESCs made in the lab) and reference preparations(1. commercial capsules; 2. commercial soft capsules) was carried out in Beagle dogs using cross over design. The drug concentration in plasma of the dogs was analyzed by HPLC method. Variance analysis and two-one-side test were used to evaluate the bioequivalence. Results Compared to the reference preparations, SESCs exhibited significant difference in bioavailability. The results of single-dose administration experiment showed that the bioavailabilities of SESCs were 160.09% and 139.13%,respectively, comparing to the commercial capsules and soft capsules. Conclusions The absorption degree of SESCs was higher than the commercial capsules and soft capsules.
出处
《中国药剂学杂志(网络版)》
2006年第3期92-97,共6页
Chinese Journal of Pharmaceutics:Online Edition