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目的:研究自制的双氯芬酸二乙胺凝胶贴剂的兔体内的药动学特征。方法:外贴经皮给药,以德国上市贴剂Flector EP-flaster为参比制剂,用HPLC测定不同时间血药浓度,用3P97药动学程序进行处理,计算药动学参数,并对2种制剂在体内的主要药动学参数分别进行t检验。结果:兔透皮给予双氯芬酸二乙胺后的药动学过程符合一室模型,2种贴剂的药动学参数AUC、Cmax、tmax、t1/2(ka)、ka和Lagtime差异无显著性(P>0.05),而t1/2(ke)和ke差异有显著性(P<0.05),CL/F和V/F差异有极显著性(P<0.01)。结论:自制的双氯芬酸二乙胺凝胶贴剂与相应的德国贴剂相比,具有更缓释、长效的作用。
Objective: To study the pharmacokinetics of homemade diclofenac diethylamine gel patch in rabbits. Methods: The transdermal drug was applied externally to the German listed patch Flector EP-flaster as reference preparation, the plasma concentration was measured by HPLC at different time, and the pharmacokinetic parameters were calculated by 3P97 pharmacokinetic program. The main pharmacokinetic parameters of the preparations in the body were t test. Results: The pharmacokinetics of diclofenac diethylamine in rabbits accorded with one-compartment model. There was no significant difference in pharmacokinetic parameters AUC, Cmax, tmax, t1 / 2 (ka), ka and Lagtime between the two patches (P <0.05), while the difference between t1 / 2 (ke) and ke was significant (P <0.05). The difference between CL / F and V / F was significant (P <0.01). CONCLUSION: The homemade diclofenac diethylamine gel patch has a more sustained and long-lasting effect than the corresponding German patch.