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目的 研究猕猴静脉推注加滴注 (2 0 %∶80 % )10、2 0和 4 0 μg·kg- 1重组人碱性成纤维细胞生长因子 (rhbFGF)后血清抗原浓度 时间变化和药代动力学并与静脉推注比较。方法 ELISA法 ,测定浓度的专一性、灵敏度、重现性和测定范围 ,血清回收率和精密度均良好。结果 猕猴血清内源性水平(14 4± 10 1)ng·L- 1;静脉推注后即刻浓度最高 ,分别为 (33± 16 ) ,(5 6± 8)和 (91± 2 8) μg·L- 1,滴注期间稳定在 2 2～ 2 7,37～ 4 4和 6 3～ 6 5 μg·L- 1,提示控制药量和滴注速率可使浓度维持在不同水平。停药后浓度迅速下降 ,平均末端相半衰期 (t1/ 2 )为 2 .6～2 .9h。AUC( 0～∞ ) 随剂量成正比增大 ,全身清除率Cls不变。结论 在给药量范围内表现为线性药代动力学。静脉推注药代动力学与推注加滴注组相近。
Objective To study the changes of serum antigen concentration after 10, 20 and 40 μg of recombinant human basic fibroblast growth factor (rhBFGF) injected intravenously (20%, 80% Kinetic and compared with intravenous bolus. ELISA method was used to determine the concentration specificity, sensitivity, reproducibility and determination of the range, serum recovery and precision are good. Results The endogenous level of cynomolgus monkey serum was (14 4 ± 10 1) ng · L -1, and the highest concentration was (33 ± 16), (56 ± 8) and (91 ± 28) μg · L-1, stable during infusion of 2 2 ~ 27,37 ~ 44 and 6 3 ~ 6 5 μg · L- 1, suggesting that the control of the dose and instillation rate can be maintained at different levels of concentration. After stopping the concentration decreased rapidly, the average terminal phase half-life (t1 / 2) was 2.6 ~ 2.9h. AUC (0 ~ ∞) increased with the dose proportional to the systemic clearance rate of Cls unchanged. Conclusions The linear pharmacokinetics was demonstrated over the dose range. Intravenous bolus pharmacokinetics were similar to bolus and bolus groups.