盐酸格拉司琼片剂人体内药动学的研究

目的研究盐酸格拉司琼片剂的人体药代动力学。方法采用甲醇-0．05M醋酸钠缓冲液（70：30，pH=6．0，含0．25％三乙胺）为流动相，以HPLC法测定30名男性健康志愿者单剂量口服2mg受试片剂后的血药浓度。结果药-时数据经3p87程序处理，得到格拉斯琼的Cmax为10．6±4．0μg·L^-1；达峰时间tmax分别为1．37±10．2h；消除相半衰期t1／2ke为7．19±4．11h；AUC0→36h为79．9±51．1μL·h^-1；AUC0→∞为85．0±54．5μg·L^-1·h。结论本HPLC方法可快速测定药物血药浓度。操作简洁，分析快速准确。格拉司琼片剂药动学参数表明，血药浓度和药代动力学参数个体变异较大，建议临床使用此药时应根据病人的具体情况采用个性化用药方案，以达到最佳疗效。

Human Pharmacokinetics of Granisetron Hydrochloride

Objective To study on the human pharmacokineties of granisetron hydroehloride. Methods Methanol - 0.5M sodium acetate buffer （70：30, pH =6.0, with 0.25% triethylamine） was taken as the mobile phase, and the plasma concentration of 30 male volunteers after oral administration of 2 mg granisetron hydrochloride was detected by HPLC. Results The process of the drug - time data by Program 3p87 showed out that Cmax was 10.6 ±4.0, tmax 1.37 ± 10.2, elimination phase half time 7.19 ±4.11, AUC0→ 36h 79.9± 51.1μg · L^-1. h and AUC0∞ 85.0 ± 54.5. Conclusions The method is quick, accurate and simple - opelated in detecting the plasma concentration; the pharmacokinetics parameters indicate a big individual difference of the plasma concentration and the parameters, which suggests that individual drug administration plan be made based on the actual condition of each patient so as to gain the best effct.