摘要
目的：建立毛细管气相色谱电子捕获检测（ＧＣＥＣＤ）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ｐｏＮｉｔ片剂２０ｍｇ，ＧＣＥＣＤ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１．０～８０．０ｎｇ·ｍｌ－１，平均回收率为（９４．３３±７．６６）％，日内和日间误差分别低于４％和８％，单剂量ｐｏＮｉｔ片剂２０ｍｇ后，药时曲线呈一室模型，ｃｍａｘ＝（９．１１±３．６２）ｎｇ·ｍｌ－１，ｔｐｅａｋ＝（３．１７±０．２５）ｈ，ＡＵＣ＝（４５．０５±１４．５０）ｎｇ·ｈ·ｍｌ－１，ｔ１／２Ｋｅ＝（３．０７±０．３３）ｈ，ｔ１／２Ｋａ＝（１．３２±０．３３）ｈ。结论：ＧＣＥＣＤ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。
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 1.0 to 80.0 ng·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)h。CONCLUSION:This method is simple,quick and highly sensitive.It provides a suitable analysis method for pharmacokinetic studies.
出处
《中国药学杂志》
CAS
CSCD
北大核心
1997年第3期155-157,共3页
Chinese Pharmaceutical Journal
