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盐酸氨基葡萄糖颗粒在健康人体的药代动力学和相对生物利用度
Pharmacokinetics and relative bioavailability of glucosamine hydrochloride granules in Chinese healthy volunteers
【摘要】 目的研究盐酸氨基葡萄糖(预防与治疗骨关节炎药)在健康人体内药代动力学和相对生物利用度。方法18名健康男性受试者随机交叉单剂量口服盐酸氨基葡萄糖受试制剂和参比制剂各480 mg,用液相色谱串联质谱法测定给药后不同时间的血药浓度,计算主要药代动力学参数。结果盐酸氨基葡萄糖受试制剂和参比制剂主要药代动力学参数:t1/2分别为(1.57±0.67)、(1.40±0.46)h;tmax分别为(2.75±0.43)、(2.86±0.48)h;Cmax分别为(1.17±0.97)、(1.27±1.07)μg·mL-1;AUC0→t分别为(3.28±2.05)、(3.38±1.94)μg·h·mL-1;AUC0→∞分别为(3.48±2.06)、(3.56±1.93)μg·h·mL-1;受试制剂的相对生物利用度为(101.28±31.92)%。结论2制剂具有生物等效性。
【Abstract】 Objective To study the pharmacokinetics and relative bio- availability of glucosamine hydrochloride in healthy volunteers.Methods A single oral dose 480 mg of glucosamine hydrochloride test and refer- ence were given according to a randomized two way cross-over design. The glucosamine concentrations in plasma were determined by HPLC- MS/MS.Results Mean pharmacokinetic parameters after oral adminis- tration of glucosamine hydrochloride test and reference were as follows: t1/2were(1.57±0.67),(1.40±0.46)h;tmaxwere(2.75±0.43), (2.86±0.48)h;Cmaxwere(1.17±0.97),(1.27±1.07)μg·mL-1; AUC0→twere(3.28±2.05),(3.38±1.94)μg·h·mL-1;AUC0→∞ were(3.48±2.06),(3.56±4.93)μg·h·mL-1.The relative bio- availability of test to reference was(101.28±31.92)%.Conclusion The reference and test formulations are bioequivalent.
【Key words】 glucosamine; HPLC-MS/MS; pharmacokinetics; relative bioavailability;
- 【文献出处】 中国临床药理学杂志 ,The Chinese Journal of Clinical Pharmacology , 编辑部邮箱 ,2008年06期
- 【分类号】R969.1
- 【被引频次】16
- 【下载频次】481