摘要
目的:建立阿比朵尔血药浓度测定方法,并用于研究阿比朵尔人体代谢过程。方法:采用高效液相色谱紫外检测法测定阿比朵尔的血药浓度,紫外检测波长315 nm。色谱柱:Alltech Apollo C_(18)(5μm,4.6 mm×250 mm);流动相:0.1%三乙胺水溶液(加磷酸调 pH 至2.0)-乙腈(52.5:47.5)梯度洗脱;流速:1.0 mL·min^(-1)。用该方法测定24名健康志愿者单次口服0.6 g 血浆药物浓度,应用 DAS1.0计算其药动学参数。结果:血药浓度线性范围0.005～2.56 μg·mL^(-1),线性良好,r=0.9997,血浆最低检测浓度为0.005μg·mL^(-1),该方法的相对回收率为93.16%～101.2%,绝对回收率为88.61%～96.99%,日内、日间 RSD(n=5)分别为2.1%～2.9%和1.6%～3.9%。24名健康志愿者单次口服0.6g 的 AUC_(0-t)为8055.08 mg·h·mL^(-1),T_(max)为1.5h,C_(max)为0.869 μg·mL^(-1),T_(1/2)为10.59 h。结论:本法操作简便,灵敏度高,重现性好,可以满足本试验低浓度药物测定及药代动力学研究。
Objective：To establish an HPLC method for determination of arbidol and study its pharmacokinetics in healthy volunteers. Methods：The arbidol in human plasma was determinated by HPLC at 315 nm. The sample was separated on Alltech Apollo C18 （5μm ,4. 6 mm× 250 mm）, eluted gradiently with 0. 1% triethylamine （pH was adjusted to 2. 0 by phosphoric acid） -acetonitrile （52. 7： 47.5） as the mobile phase at flow rate 1.0 mL · min^-1 The pharmacokinetic parameters were analyzed by DAS1.0. Results：It showed a good linear range of 0. 005 -2. 56 μg · mL^ - 1 （ r = 0. 9997 ）. The limited detection concentration was 0. 005 μg · mL^- 1. The relative recovery was 93.16% - 101.2% ,the absolute recovery was 88.61% -96. 99% ,the intra - day RSD and the inter - day precisions RSD were 12. 1% -2.9% and 1.6% -3.9% （n = 5 ）. After a single oral dose of 0. 6 g arbidol hydrochloride,the main pharmacokinetic parameters AUC0-t,Tmax, Cmax and T1/2 were 8055.08 mg· h^-1· mL^-1, 1.5 h,0. 869 μg · mL^-1,10. 59 h respectively. Conclusion：This method is convenient, sensitive and reproducible. It is suitable for determination of low concentration drug and the demand of pharmacokinetic and bioequivalence study.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2007年第6期817-820,共4页
Chinese Journal of Pharmaceutical Analysis
