LC-MSMS法测定人血浆中卡络磺钠的浓度.doc

文档介绍：LC-MS/MS法测定人血浆中卡络磺钠的浓度
赵华,宋敏,杭太俊
(中国药科大学药学院药物分析教研室,南京 210009)
摘要目的:建立人血浆中卡络磺钠浓度的LC-MS/MS测定法,并用于卡络磺钠的人体药代动力学研究。方法:24名健康志愿者单剂量口服90mg卡络磺钠胶囊,,,,,,,,,,, ,,APCI正离子化LC-MS/MS法测定血浆中卡络磺钠的浓度。结果:卡络磺钠LC-MS/ ng∙mL-1~50 ng∙mL-1范围呈现良好线性,%~%。批内、%~%%~%。主要血浆药动学参数Cmax为(± ) ng∙mL-1,Tmax为( ± ) h,t1/2为(± ) h,MRT为( ± ) h,AUC0-8为( ± ) h·ng∙mL-1,AUC0-¥为( ±) h·ng∙mL-1,Vz/F为(± ) L,CL/F为( ± ) L∙h-1。结论:健康志愿者单剂量口服90mg卡络磺钠胶囊后,卡络磺钠血浆浓度-时间曲线符合二房室模型。 ng∙mL-1~ ng∙mL-1范围, h~3 h范围,个体差异较大。
关键词:卡络磺钠;药代动力学;LC-MS/MS
Determination of carbazochrome sodium sulfonate in human plasma by LC-MS/MS
ZHAO Hua*作者简介: 赵华,女,药物分析硕士研究生 Tel: [phone] E-mail: cucupig@
, Song Min, HANG Tai-jun
(Department of Pharmaceutical Analysis, China Pharmaceutical University, NanJing, 210009,China)
Abstract Objective: To establish an LC-MS/MS method for the determination of carbazochrome sodium sulfonate in human plasma and study its ics. Methods: A single oral dose of 90 mg carbazochrome sodium sulfonate capsules was given to each of 24 Chinese healthy volunteers. Blood samples were collected before and ,,,,,,,,,, ,
, h after the administration. The drug plasma concentrations were determined by a validated LC-MS/MS method in APCI positive ion mode. Results: The calibration curve of the LC-MS/MS method was linear in the range of ng·mL-1-50 ng·mL-1 with the accuracy from 90% to 105%. The intra-day and inter-day precession (RSD) were %-% and %-%, respectively. The main ic parameters of carbazochrome sodium sulfonate after a single oral dose 90mg were as follows, Cmax (± ) ng∙mL-1,Tmax ( ± ) h,t1/2 (± ) h,MRT ( ± ) h,AUC0-8 ( ± ) h·ng∙mL-1,AUC0-¥ ( ±) h·ng∙mL-1,Vz/F (± ) L,CL/F ( ±