摘要
目的研究枸橼酸莫沙必利片在健康人体内的药动学。方法12例健康男性志愿者均单剂量口服枸橼酸莫沙必利片10 mg,采用高效液相色谱法[固定相:Hypersil C18色谱柱(5μm,4.6 mm×200 mm);流速:1.0mL.m in-1;柱温:40℃;流动相:0.02 mol.L-1磷酸二氢钾溶液(用1 mol.L-1磷酸溶液调节pH值至5.0)∶甲醇=75∶25;激发波长:314 nm;发射波长:352 nm]测定给药前及给药后10 h内不同时点的血药浓度,采用DAS1.0程序计算药动学参数。结果枸橼酸莫沙必利在健康人体内的处置过程符合一室模型,其主要药动学参数中,Ka为(1.45±0.93)h-1;tm ax(实测值)为(1.15±0.57)h;Cm ax为(58.57±22.01)μg.L-1;AUC0→10为(176.60±69.40)μg.h-1.L-1;t1/2为(1.41±0.38)h。结论枸橼酸莫沙必利片的药动学过程符合一室模型。
Objective To study the pharmacokinetics of mosaprlde citrate tablets in healthy humans. Methods 12 healthy male volunteers were given each a single oral dose of 10 mg of mosapride citrate tablets. The concentrations of mosapride in the blood plasma before the administration and at different time points within 10 hours after the medication were determined with HPLC [ Stationary phase： a Hypersil C 18 chromatographic column （5 μm, 4.6 mm×200 nun） ; flow rate： 1.0 mL·min^-1;mobile phase： 0.02 mol· L^-1 potassium dihydrogen phosphate solution （ pH adjusted to 5.0 with 1 mol· L^-1 phosphoric acid solution） ： acetonitrile =75 ： 25; column temperature：40℃; excitation wavelength：314 nm; emission wavelength：352 nm]. The DAS 1.0 program was used to calculate the pharmacokinetic parameters. Results The management process of mosapride citrate in the human body after the administration accorded with the one-compartment model. The main pharmacokinetic parameters of the drug were as follows： K, was （1.45 ± 0.93 ） h^-1 ;tmax （determined value） was （1.15 ±0.57 ） h; Cmax, （58.57 ±22.01）μg· L^-1;AUC（0→10）（ 176.60 ±69.40）μg· h^-1· L^-1;t1/2, （1.41 ±0.38） h. Conclusion The pharmacokinetic process of mosapride citrate in the human body was shown to be in accordance with the one-compartment model. K
出处
《医药导报》
CAS
2006年第8期756-757,共2页
Herald of Medicine
