双氯芬酸钠人体内的药代动力学

Pharmacokinetics of diclofenac sodium microemulsion in human

目的 :研究双氯芬酸钠卵磷脂微乳在人体内的药代动力学。 方法 :10例健康男性志愿者单剂量口服双氯芬酸钠微乳和肠溶衣片 ,以吲哚美辛为内标 ,用反相 HPL C法 ,紫外 2 80 nm处测定血清中双氯芬酸钠浓度。数据用 3P87程序处理。结果 :双氯芬酸钠质量浓度在 5 0～ 80 0 0μg/ L范围内线性关系良好 (r=0 .9996 ) ,最低检测浓度为 30μg/ L ,平均空白回收率为(10 0 .5 5± 1.5 6 ) %。双氯芬酸钠微乳和肠溶衣片 AU C0～∞ 分别为 5 .5 6 3、7.891μg· h/ ml,MRT分别为 5 .489、5 .387h。结论 :双氯芬酸钠微乳具有特殊的吸收机制。

Objective: To study the pharmacokinetics of diclofenac sodium microemulsions in human. Methods: According to the crossover design, each volunteer was orally given diclofenac sodium microemulsion and diclofenac sodium tablet. The serum concentrations were determined by RP HPLC with UV detector. The concentration time data were analyzed using 3P87 Pharmacokinetic Program and the pharmacokinetics parameters were compared by paired t test. Results: It was found that diclofenac sodium in serum was linear within the range of 50 8 000 μg/L. The minimum detection concentration was 30 μg/L. The mean rate of recovery was (100.55±1.56)%. After a single oral dose, AUC 0~∞ were 5.563,7.891 μg·h/ml, MRT 5.489, 5.387 h for dispersible diclofenac sodium microemulsion and tablet respectively. Conclusion: Absorption progress of diclofenac sodium microemulsion in human may be special. [