HPLC法测定盐酸安他唑啉的血药浓度及其药动学研究.docxVIP

HPLC法测定盐酸安他噪咻的血药浓度及其药动学研究 石迎迎1陈辞2 1 ?郑州人民医院药学?部河南郑州450000； 2?河南省人民医院药学部河 南郑州450003 摘要：目的 建立一种简便、选择性强的HPLC法，用来测定Beagle犬血浆 中盐酸安他哇咻的浓度，并研究其在Beagle犬内的药动学行为。方法 采用液? 液萃取法提取血浆中的药物，用HPLC法来测定血浆中盐酸安他哇I咻的含量。结 果 盐酸安他哇咻在20.0~1600ng?ml-l的线性关系良好(Rgt;0.99),最低定量 限20.0n g?ml-l,提取回收率高于80%,日内、日间RSD值均在15 %范围内。 Beagle犬静脉注射给药后得击了主要动力学参数Tl/2, AUC0ndash;t, AUCOndash;infin;, CL。结论木文首次建立了 Beagle犬血浆中盐酸安他卩坐咻 的HPLC法。该法快速、准确、灵敏，并成功用于盐酸安他哇卩林在Beagle犬体内 的药动学研究。 关键词：盐酸安他哇咻；HPLC；药代动力学；Beagle犬 Abstract： Aim In order to establish a simple and good selectivity of the HPLC analysis method for determine the concentration of Antazoline hydrochloride in Beagle dog plasma and to study the pharmacokinetic characters in Beagle dogs.Methods Plasma samples were processed by liquid-liquid extraction and the HPLC analysis method was developed to determine the concentration of Antazoline hydrochloride in Beagle dog plasma.Results Standard calibration graph for Antazoline hydrochloride was linear within a range of 20-1600ng?mL-l (Rgt;0.99) and the lower limit of quantification was 20 ng?mL?l.The extraction recoveries were greater than 80%, the intra- and inter-day precision values were less than 15% relative standard deviation (R.S.D)?After intravenous injection, the main pharmacokinetic parameters of Tl/2, AUC0ndash;t, AUC0ndash;infin;, CL were fin ally got.C onclusion The RP-HPLC method was established first in order to determine Antazoline hydrochloride in Beagle dog plasma.The method is sensitive, specific, quick and easy for determination of Antazoline hydrochloride in Beagle dog plasma and to study the pharmacokinetics. Key words： Antazoline hydrochloride； RP-HPLC； Beagle dog； Pharmacokinetics 盐酸安他卩坐咻原本为乙二胺类抗组胺药，临床应用于心律失常的治疗［1, 2］, 为一老药新用的la类抗心律失常药物［3, 4］。临床研究发现，其对于洋地黃导致 的室性心动过速与异位搏动以及实验性的阵发性室性心动过速具有显著的预防 和治疗效果［5］。对于不能耐受奎尼丁以及其他抗心律失常药物的患者，其在治 疗室性早搏、房性早搏以及室性心动过速等方面更加适用［6-7］o 1材料与方法 1.1药品与试剂 盐酸安他卩坐II林对照品（批号含量：99.8%,上海玉瑞生物科技 有限公司安阳分公司）；内标非那西丁（批号：0095-8904,纯度：99.99%,中国 药品生物制品鉴定所）。 甲醇为色谱纯，购自美国Fisher公司；其它试剂