气相色谱法测定溴己新血药浓度及药代动力学研究

Determination of Bromhexine in Plasma by Gas Chromatography- Electron Capture Detection and Pharmacokinetic Studies

建立了人血浆中溴己新的气相色谱 电子捕获测定法 ,对溴己新胶囊在健康人体内的药代动力学进行了研究。色谱柱为 5 %SE 30 (2m× 3mmi.d .)硅烷化玻璃柱。 5 氯 2 氨基二苯甲酮为内标 ,血浆样品加入磷酸盐缓冲液 (pH 6 0 )后用正己烷 二氯甲烷 (体积比为 9∶1)提取。线性范围为 1 0 μg/L～ 5 0 0 μg/L ,r =0 9994。人血浆中最小检测质量浓度为 0 5 μg/L。方法重现性好 ,日内、日间RSD分别小于 4 5 6 %和 7 11% ,平均回收率 97 5 %。 8名健康志愿者口服 8mg溴己新胶囊后 ,其体内代谢过程符合一房室模型。方法可用于体内血药浓度测定 ,简单、快速 ,灵敏度高 。

This paper reports a gas chromatography electron capture detection(GC ECD) method for the study of pharmacokinetics of bromhexine in healthy human body A 2 m×3 mm i.d. silanized glass column packed with 5% SE 30 was used The carrier gas was nitrogen The internal standard was 5 chloro 2 amino diphenyl ketone After NaH\-2PO\-4 Na\-2HPO\-4 buffer (pH 6 0) being added, the plasma was extracted with n hexane dichloromethane (9∶1, V/V ) A good linearity was obtained from 1 0 μg/L to 50 0 μg/L of bromhexine in human plasma, r =\{0 999 4 \} The detection limit of bromhexine in plasma was 0 5 μg/L The average recovery was 97 5% The pharmacokinetics of bromhexine was determined by this method after a single oral dose of 8 mg bromhexine capsule given to each of 8 volunteers The results showed that the plasma concentration time courses conformed to one compartment model The established GC ECD method is a good method for the determination of bromhexine in human plasma The method is rapid, simple, precise and sensitive.