尼莫地平自乳化软胶囊的药物动力学
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孙 辉1 ，张晓非2 ，王思玲1 ，(1.沈阳药科大学 药学院， 辽宁 沈阳 110016 ； 2.沈阳贝朗制药有限公司，辽宁 沈阳 110024)
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。
关键词：药剂学；药物动力学；高效液相色谱法；尼莫地平自乳化软胶囊；生物等效性
中图分类号：R94 文献标识码：A
contents
Pharmacokinetics of nimodipine self-emulsifying soft capsules
SUN Hui1, ZHANG Xiao-fei 2, WANG Si-ling 1
(1.School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016，China; 2. Shenyang B.Braun Pharmaceutical Co. Ltd., Shenyang 110024, China)
Abstract: 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.
Key words: pharmaceutics; pharmacokinetics; HPLC; nimodipine self-emulsifying soft capsules(SESCs); bioequivalence
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