高效液相色谱-荧光检测法测定人血清中丙戊酸钠浓度

目的 :建立测定人血清中丙戊酸钠浓度的检测方法 ,并研究国产和进口复方丙戊酸钠缓释片稳态谷浓度 (Cssmin)的等效性。方法 :20名健康男性志愿者两周期随机交叉多次口服国产和进口复方丙戊酸钠缓释片 ,采用高效液相色谱 -荧光检测法测定血清中丙戊酸钠的谷浓度 ,并用3p97程序对试验数据进行处理。结果 :口服国产及进口复方丙戊酸钠缓释片3d后 ,血药浓度达稳态 ,Cssmin分别为 (38 17±9 36)、(35 48±9 44)mg/L ,且单次和多次服用两种制剂Cssmin等效。结论 :本检测方法快速、灵敏、经济 ,可用于监测人血清中丙戊酸钠的浓度。

Concentration Determination of Sodium Valproate in Human Serum by HPLC- Fluorescence Detection Method

OBJECTIVE:To establish a method for the determination of sodium valproiate in human serum and to study the bioequivalence of steady state concentration C ssm in of the domestic and imported sodium valproiate sustained-release compound tablets.METHODS:Two periods of multi-oral administration of domestic and imported sodium valproiate sustained-release compound tablets were conducted alternately at random on20healthy male volunteers;the trough concentration of sodium valproate in human serum was determined by HPLC-fluorescence detection and the data were analyzed by3p97proˉgram.RESULTS:The blood concentration was steady after3d oral administration of both the domestic and imported sodium valproate sustained-release compound tablets.The C ssm in of domestic and imported products were(38.17±9.36)、(35.48±9.44)mg/L respectively.C ss min of domestic and imported sodium valproate sustained-release compound tablets were of bioeˉquivalence either single or multi-oral administration.CONCLUSION:This HPLC-fluorescence method is quick,sensitive and economical,which can be used to monitor the concentration of sodium valproate in human serum.