干旱区生态环境知识资源中心(Arid): HPLC-MS/MS法测定人血浆中草乌甲素的浓度及生物等效性研究

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	HPLC-MS/MS法测定人血浆中草乌甲素的浓度及生物等效性研究
其他题名	Determination of Bulleyaconitine A in Human Plasma by HPLC-MS/MS and Its Bioequivalence Study
	李相鸿 ; 孙华 ; 贾元威 ; 周理想 ; 王伟佳 ; 戴敏 ; 赵亚男 ; 谢海棠
来源期刊	天然产物研究与开发
ISSN	1001-6880
出版年	2011
卷号	23 期号:6 页码:1031-1037
中文摘要	本文建立了一种快速、高灵敏的HPLC-MS/MS法用于检测人血浆中的草乌甲素浓度。血浆样品采用沃特斯HLB小柱进行固相萃取，汉邦C_(18)色谱柱（150mm*4.6mm，5mum）进行分离，流动相为甲醇：水(85:15,v/v)，水相含10mmol/L的醋酸铵和0.1%的甲酸。采用ESI源和多反应监测（MRM）的方式进行检测，草乌甲素及内标的反应离子对分别为644.4/584.4和237.2/194.2，草乌甲素血药浓度在0.010~1.0ng/mL范围内线性关系良好，最低定量限为0.010ng/mL可以满足口服0.4mg草乌甲素后血药浓度的检测，日内日间及质控样品精密度及准确度均在允许范围内。本检测方法被成功的应用在中国健康志愿者生物等效性研究中，20名志愿者口服0.4mg草乌甲素试验制剂和参比制剂后主要药代动力学参数分别如下：C_（max）（0.3250.110）,(0.3230.115)ng/mL;AUC_(0-16)(1.6270.489),(1.7320.556)ng?h/mL; AUC_(0-)(1.7300.498),(1.8310.562)ng?h/mL;t_(1/2)（4.260.95），（3.800.90）h;T_(max)（1.340.54），（1.830.99）h。
英文摘要	A high-performance liquid chromatography/electrospray ionization tandem mass spectrometry (HPLC-ESI-MS/MS) method was developed and validated for the determination of Bulleyaconitine A(BLA) in human plasma using carbamazepinum as internal standard (IS). Plasma samples were extracted with Waters Oasis HLB solid-phase cartridges, separated on a reversed C_(18) column (150 mm*4.6 mm,5mum) with a mobile phase of methonal - 10 mmol/L ammonium acetate solution containing 0.1% formic acid (85:15,v/v). Bulleyaconitine A and IS were detected in the multiple reaction monitoring mode (MRM) with precursor to product ion transitions of m/z 644.4/584.4 and 237.2/194.2, respectively. The method exhibited a linear range of 0.010-1.0 ng/mL for BLA in human plasma. The lowest lim-it of quantification (LLOQ) was 0.010 ng/mL, which was sensitive enough for the pharmacokinetic study of BLA. Acceptable precision and accuracy were obtained for concentrations of the calibration standard and the quality control (QC). The validated method was successfully applied for evaluation of a bioequivalence study in Chinese healthy volun-teers. The main pharmacokinetics parameters after oral administration of 0.4mg BLA test or reference formulation were as follows: C_(max)(0.3250.110),(0.3230.115) ng/mL; AUC_(0-16)(1.6270.489),(1.7320.556) ng·h/mL;AUC_(0-)(1.7300.498),(1.8310.562)ng?h/mL; t_(1/2)(4.260.95),(3.800.90)h;T_(max)(1.340.54),(1.830.99)h。
中文关键词	草乌甲素 ; 血药浓度 ; 生物等效性
英文关键词	HPLC-MS/MS bulleyaconitine A plasma drug concentration bioequivalence HPLC -MS/MS
语种	英语
国家	中国
收录类别	CSCD
WOS类目	PHARMACOLOGY PHARMACY
WOS研究方向	Pharmacology & Pharmacy
CSCD记录号	CSCD:4401487
资源类型	期刊论文
条目标识符	http://119.78.100.177/qdio/handle/2XILL650/227153
作者单位	1.Department of Clinical Pharmacy, Yijishan Hospital of Wanna Medical College, Wuhu, Anhui China; 2.Anhui Provincial Centre for Drug Clinical Evaluation, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui China
推荐引用方式 GB/T 7714	李相鸿,孙华,贾元威,等. HPLC-MS/MS法测定人血浆中草乌甲素的浓度及生物等效性研究[J],2011,23(6):1031-1037.
APA	李相鸿.,孙华.,贾元威.,周理想.,王伟佳.,...&谢海棠.(2011).HPLC-MS/MS法测定人血浆中草乌甲素的浓度及生物等效性研究.天然产物研究与开发,23(6),1031-1037.
MLA	李相鸿,et al."HPLC-MS/MS法测定人血浆中草乌甲素的浓度及生物等效性研究".天然产物研究与开发 23.6(2011):1031-1037.