GC-MS法研究麻黄汤中麻黄碱、伪麻黄碱的人体内过程

目的建立用于同时测定麻黄碱( ephedrine, E)、伪麻黄碱( pseudoephedrine, PE)血药浓度的气相色谱-质谱法( GC-MS),并探讨二者在人体内的药代动力学.方法用 GC-MS法测定人血药浓度,所得数据用 WinNonlin4.0.1药代动力学程序处理,求出有关参数.结果 E、 PE分别在 5～ 1000 ng/mL, 2.5～ 500 ng/mL的范围内线性关系良好(R2=0.9985,r2=0.9994) ,加样回收率分别为 107.5 %～ 96.2 % , 102.5 %～ 93.9 %.两者日内、日间精密度的RSD < 5 %,血浆样品 60 d内稳定,符合生物样本分析要求.结论该方法稳定、准确,灵敏度高,适于 E、 PE的血药浓度测定.

Human Pharmacokinetics of Ephedrine and Pseudoephedrine in Mahuang Tang by GC-MS

Objective To develop a gas chromatography-mass spectrometry (GC-MS) method for the determination of ephedrine (E) and pseudoephdrine (PE) and to study the pharmacokinetics features of E and PE in healthy human volunteers. Methods The serum concentrations of E and PE were measured by GC-MS. The pharmacokinetic parameters were computed by using WinNonlin program. Results A good linearity was obtained in E from 5 ng/mL to 1000 ng/mL (r2=0.9985) and in PE from 2.5 ng/mL to 500 ng/mL (r2=0.9994). The recoveries were in the range of 107.5 %to 96.2 %and 102.5 %to 93.9 %for E and PE respectively. The interday RSD and intraday RSD of E and PE were both less than 5 %. The E and PE plasma solution were steady within 60 days. Conclusion This GC-MS method is a accurate and reliable method for the determination of E and PE in human plasma.