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采用一步液液提取反相高效液相色谱法对甘氨酸茶碱钠缓释片 (受试制剂 )与普通片 (参比制剂 )在人体内药物动力学行为进行了对比检测 ,绘制了 12名健康男性志愿受试者分别单剂量和多剂量随机交叉口服上述两种制剂后的茶碱血浆浓度 时间曲线并计算主要的药动学参数 .经统计检验 ,两种制剂的AUC无显著性差异 .单剂量和多剂量口服甘氨酸茶碱钠缓释片的相对生物利用度分别为 (91.7± 16 .8) %和 (10 7.5± 18.6 ) % .与普通片相比 ,甘氨酸茶碱钠缓释片的Cmax较低 ,而Cmin较高 ,Tmax明显滞后 ,MRT延长 ,血药浓度波动幅度显著减小 ,符合缓释制剂的特点 ,可较为安全地应用于临床 .
A one-step liquid-liquid extraction reverse-phase high performance liquid chromatography (HPLC) was used to compare the pharmacokinetics of glycine theophylline sodium sustained-release tablets (test preparation) and ordinary tablets (reference preparation) in human body. The pharmacokinetic parameters of theophylline plasma concentrations in male volunteers after single and multiple doses of crossover oral administration of the above two formulations were calculated and the main pharmacokinetic parameters were calculated.According to statistical test, there was no significant difference in AUC The relative bioavailability of oral and multidose oral glycine theophylline sodium sustained-release tablets were (91.7 ± 16.8)% and (10 7.5 ± 18.6)%, respectively. Compared with common tablets, Cmax is lower, while Cmin is higher, Tmax lags behind obviously, MRT prolongs, the fluctuation range of plasma concentration is significantly reduced, which accords with the characteristics of sustained-release preparation and can be safely used in clinic.