毛细管气相色谱测定尼群地平血药浓度方法的研究

 目的:建立毛细管气相色谱-电子捕获检测( GC-ECD)法以测定人血浆中尼群地平(Nit )含量的方法，并用此法测定Nit片剂的药动学参数。方法:4名健康志愿者一次po Nit片剂20 mg, GC-ECD法测定血浆中Nit含量，3P87实用药动学程序处理实验数据。结果:线性范围为1.0～80.0 ng·ml^-1，平均回收率为(94.33±17.66)%,内和日间误差分别低于4%和8%，单剂量po Nit片剂20 mg后，药时曲线呈一室模型,c_max=(9.1113.62) ng·ml^-1，t _peak=(3 .17±0.25) h, AUC=(45.05±14.50)ng·h·ml^-1，t_{1/2Ke=(3.07±0.33)h, t1/2Ka=(1.32±0.33)h.结论:GC'-ECD法测定方法简便，灵敏度高，能满足血药浓度测定及药动学研究的需要。}

Determination of nitrendipine in human plasma by capillary gas chromatography

OBJECTIVE:To establish a gas chromatography-electrical conductivity detector(GC-ECD) method for the determination of nitrendipine in human plasma and study the pharmacokinetics of nitrendipine tablet in healthy volunteers. METHODS:The blood level of nitrendipine at different time after oral nitrendipine table at a single dose of 20 mg in 4 healthy volunteers was determined by GC-ECD method. The 3P87-automatic pharmacokinetic program was used for the selection of optimal compartment model and calculation of pharmacokinetic parameters. RESULTS: The method was linear within the range from 1.0to80.0ng·ml^-1.The average recovery was (94.33±7.66)%and the validation of inter-day and intra-day was less than 4% and 8%，respectively. After oral nitrendipine tablet at a single dose of 20 mg, the results showed that the plasma drug was in line with the one-compartment model. c_max=(9.11±3.62)ng·ml^-1，t_peak=(3.17±0.25)h, AUC=(45.05±14.50)ng·h·ml^-1，t_1/2Ke=(3.07±0.33)h, t_1/2Ka=(1.32±0.33) ho CONCLUSION:This method is simple, quick and highly sensitive. It provides a suitable analysis method for pharmacokinetic studies.