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目的建立人血浆尿嘧啶核苷高效液相色谱测定法,进行胞磷胆碱钠健康志愿者生物等效性研究。方法 24例健康志愿者口服胞磷胆碱片或胶囊600m g,以阿莫西林为内标,采用高效液相色谱法测定尿嘧啶核苷经时血浓度,DAS软件计算尿嘧啶核苷主要药代动力学参数,评价两制剂的生物等效性。结果尿嘧啶核苷回归方程为y=2.10x+0.57(r=0.992 8),方法最低检测限为0.05μg/mL,回收率95.57%~102.09%,日内、日间RSD均小于15%。血浆尿嘧啶核苷药后3.5h达峰值,约为3.0μg/mL,然后逐渐降低,约8h至基础值。AUC0-t、AUC0~∞和Cm ax90%置信区间分别为85.3%~97.5%、85.3%~102.9%和89.5%~102.1%。结论所建立方法特异性强,灵敏度高,测定结果可靠,可用于人血浆嘧啶核苷测定。胞磷胆碱钠片和胶囊符合生物等效的假设,为生物等效制剂。
Objective To establish a method for the determination of human plasma uridine by high performance liquid chromatography and to study the bioequivalence of citicoline sodium in healthy volunteers. Methods 24 healthy volunteers oral citicoline tablets or capsules 600m g, with amoxicillin as the internal standard, high-performance liquid chromatography for the determination of uracil blood concentration over time, DAS software to calculate the main drugs uridine Substitution kinetic parameters to evaluate the bioequivalence of the two formulations. Results The regression equation of uridine was y = 2.10x + 0.57 (r = 0.992 8). The detection limit of this method was 0.05μg / mL and the recovery was 95.57% ~ 102.09%. The intra-day and interday RSD were less than 15%. Plasma uridine after 3.5h peak, about 3.0μg / mL, and then gradually decreased, about 8h to the baseline value. The confidence intervals of AUC0-t, AUC0 ~ ∞ and Cm ax were 85.3% ~ 97.5%, 85.3% ~ 102.9% and 89.5% ~ 102.1%, respectively. Conclusion The established method is specific, sensitive and reliable, and can be used for the determination of human plasma. Citicoline sodium tablets and capsules meet the bioequivalence assumption for bioequivalent formulations.