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目的:探究国产兰索拉唑的药物动力学并将其主要参数和进口兰索拉唑的药物动力学主要参数进行比较研究。方法:将收集到的40例合格受试者随机分为两组,禁食12h后观察组使用国产兰索拉唑,对照组使用进口兰索拉唑,取受试者服药前1h以及服药后1h、2h、4h、8h、12h、24h血浆进行HPLC测定,分析其药物半衰期、达到稳态时间以及最大血药浓度等主要药物动力学参数进行比较。结果:对两组分别使用国产和进口兰索拉唑的受试者血浆进行测定并采取t检验进行比较,结果显示药物半衰期、达到稳态时间以及最大血药浓度等主要药物动力学参数差异不显著(P>0.05),不具统计学意义。结论:国产兰索拉唑与进口兰索拉唑主要药物动力学参数差异不大,且国产兰索拉唑具有价格优势,值得更大的在临床上推广使用。
OBJECTIVE: To investigate the pharmacokinetics of domestic lansoprazole and to compare its main parameters with the main pharmacokinetic parameters of imported lansoprazole. Methods: Forty eligible subjects were randomly divided into two groups. After fasting for 12 hours, the patients in the observation group were treated with lansoprazole, while in the control group, lansoprazole was used. The patients were taken 1 h before taking the medicine, 1h, 2h, 4h, 8h, 12h, 24h plasma were measured by HPLC, the drug half-life, to reach the steady-state time and maximum plasma concentration and other major pharmacokinetic parameters were compared. RESULTS: Plasma concentrations of both domestic and imported lansoprazole-treated subjects were measured and t-test was used for comparison. The results showed that the differences of the main pharmacokinetic parameters between half-life, steady-state time and maximum plasma concentration Significant (P> 0.05), not statistically significant. Conclusion: The main pharmacokinetic parameters of domestic Lansoprazole and imported lansoprazole are not much different, and the domestic Lansoprazole has the price advantage, which is worth to be more widely used clinically.