摘要
目的：本文对进口和国产索他洛尔片剂在１２名男性健康志愿者中的药物动力学和相对生物利用度进行了研究。方法：建立了一个检测血清中索他洛尔浓度的反相高效液相色谱－荧光检测法。结果：单剂量口服索他洛尔１６０ｍｇ后的血药浓度数据用３Ｐ８７药物动力学程序进行模型拟合，国产片剂ＡＵＣ、Ｃｍａｘ、Ｔｍａｘ、Ｔ１／２分别为１６．２±３．６ｈ·μｇ·ｍｌ－１，１．２±０．２μｇ·ｍｌ－１，２．１±０．７ｈ，１７．０±７．２ｈ；进口片剂ＡＵＣ、Ｃｍａｘ、Ｔｍａｘ、Ｔ１／２分别为１５．９±３．５ｈ·μｇ·ｍｌ－１，１．２±０．４μｇ·ｍｌ－１，２．１±０．６ｈ，１８．６±９．４ｈ。国产片剂的相对生物利用度为１０３．５％。结论：两种片剂的所有药动学参数经统计学（ＳＰＳＳ软件）处理差异均无显著性（Ｐ＞０．０５）。
Aim:The bioavailablity of sotalol was studied in 12 healthy male volunteers after a single oral dose of 160 mg.Method:The serum level of sotalol was determined by high performance liquid chromatography with fluorescence detection.Rusults:The oral administration pharmacokinetic model was described as a twocompartment model.The pharmacokinetic parameters of sotalol(SASS) were: AUC 16.2 ± 3.6 h·μg·ml -1 , C max 1.2 ± 0.2 h·μg·ml -1 , T max 2.1 ± 0.7 h, T 1/2 17.0 ± 7.2 h.The pharmacokinetic parameters of sotalol(U.K.) were: AUC 15.9 ± 3.5 h, C max 1.2 ± 0.4 h·μg·ml -1 , T max 2.1 ± 0.6 h, T 1/2 18.6 ± 9.4 h.Conclusion:There were no significant differences in all pharmacokinetic parameters between sample and reference tablets( P > 0.05 ).The test of bioequivalent in the two preparations is the same.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
1998年第11期486-488,共3页
Chinese Journal of Hospital Pharmacy
