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目的:建立测定卡马西平(CBZ)的高效液相色谱法。分析CBZ在健康受试者体内药动学特性,探讨临床应用个体差异的原因。方法:12名健康受试者单剂量(200 mg)口服CBZ片,HPLC法测定血浆样品药物浓度。结果:CBZ的线性范围为(0.05～10)μg·ml~(-1),最低检测浓度为0.05μg·ml~(-1),方法平均回收率为94.4%。单剂量口服CBZ后血浆浓度符合一级吸收一房室模型,其主要药动学参数为:C_(max)为(4.71±0.99)μg·ml~(-1),t_(max)为(16±12)h,AUC为(361.62±49.43)μg·h·ml~(-1),t_(1/2)= (38.39±6.37)h。结论:该法测定血浆中CBZ浓度高效、灵敏、准确,CBZ体内药动学特性存在明显个体差异。
Objective: To establish a high performance liquid chromatographic method for the determination of carbamazepine (CBZ). The pharmacokinetic properties of CBZ in healthy subjects were analyzed to explore the causes of individual differences in clinical application. Methods: Twelve healthy volunteers were given a single dose (200 mg) of oral CBZ tablets, and the plasma concentration of the drug was measured by HPLC. Results: The linear range of CBZ was (0.05 ~ 10) μg · ml ~ (-1) and the lowest detection limit was 0.05μg · ml ~ (-1). The average recoveries of CBZ were 94.4%. The single-dose oral CBZ plasma concentration conformed to the one-compartment absorption-one-compartment model. The main pharmacokinetic parameters were: Cmax (4.71 ± 0.99) μg · ml -1 and t max ± 12) h, AUC was (361.62 ± 49.43) μg · h · ml -1, t 1/2 (38.39 ± 6.37) h. Conclusion: The method for the determination of plasma CBZ concentration is efficient, sensitive and accurate, there are significant individual differences in CBZ pharmacokinetics.