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目的比较单组分二甲双胍与二甲双胍复方制剂的药物动力学差异,为复方制剂的组方及临床应用提供参考。方法Beagle犬口服给予盐酸二甲双胍胶囊(10 mg.kg-1)和二甲双胍-牛磺酸复方制剂胶囊(等同于盐酸二甲双胍10 mg.kg-1),RP-HPLC法测定其血药质量浓度,拟合药物动力学曲线,计算药物动力学主要参数。结果单一制剂与复方制剂的二甲双胍在Beagle犬体内药物动力学都符合二室模型,主要药物动力学参数为AUC0-t(10.29±3.54)、(10.12±2.81)mg.h.L-1,ρmax(2.11±0.46)、(1.73±0.49)mg.L-1,tmax(2.67±0.41)、(2.50±0.45)h。结论单一制剂与复方制剂给药的二甲双胍主要药物动力学参数采用双侧t检验,无显著性差异(P>0.05),提示二甲双胍-牛磺酸复方制剂具有药物动力学理论的可行性。
Objective To compare the pharmacokinetics of single-component metformin and metformin compound prescriptions, and to provide a reference for the prescription and clinical application of compound preparations. Methods Beagle dogs were treated with metformin hydrochloride (10 mg.kg-1) and metformin-taurine (equivalent to metformin hydrochloride 10 mg.kg-1) orally, and their plasma concentrations were determined by RP-HPLC. Pharmacokinetic curve, calculate the main parameters of pharmacokinetics. Results The pharmacokinetics of metformin in single and compound preparations were in accordance with the two-compartment model. The main pharmacokinetic parameters were AUC0-t (10.29 ± 3.54), (10.12 ± 2.81) mg.hL-1 and pmax ± 0.46), (1.73 ± 0.49) mg.L-1, tmax (2.67 ± 0.41) and (2.50 ± 0.45) h, respectively. Conclusion The main pharmacokinetic parameters of metformin administered by single preparation and compound preparation are not significantly different (P> 0.05) by the two-tailed t test, which indicates that the metformin-taurine compound preparation has the pharmacokinetic theory feasibility.