固相萃取HPLC-UV法测定人血浆中比阿培南浓度及其药代动力学研究

doi:10.5246/jcps.2011.01.010

固相萃取HPLC-UV法测定人血浆中比阿培南浓度及其药代动力学研究

朱旭, 孙亚欣, 何晓静, 邱枫, 李岭, 肇丽梅^*

1. 中国医科大学附属盛京医院药学部, 辽宁沈阳 110004
2. 中国医科大学基础医学院医学遗传学教研室, 辽宁沈阳 110001
3. 东北大学中荷生物医学与信息工程学院, 辽宁沈阳 110003

收稿日期:2010-10-08 修回日期:2010-11-25 出版日期:2011-01-15 发布日期:2011-01-15
通讯作者: 肇丽梅*

HPLC-UV method with solid-phase extraction for the quantitative determination of biapenem in human plasma and its application in pharmacokinetic study

Xu Zhu, Ya-Xin Sun, Xiao-Jing He, Feng Qiu, Jesse Ling Li, Li-Mei Zhao^*

1. Department of Pharmacy, Shengjing Hospital of China Medical University, Shenyang 110004, China
2. Department of Medical Genetics, China Medical University, Shenyang 110001, China
3. Sino-Dutch Biomedical and Information Engineering School, Northeastern University, Shenyang 110003, China

Received:2010-10-08 Revised:2010-11-25 Online:2011-01-15 Published:2011-01-15
Contact: Li-Mei Zhao*

摘要/Abstract

摘要：

比阿培南是一种新型经胃肠外吸收的碳青霉烯类抗生素, 广泛用于治疗多种细菌感染。本试验建立了一种简便、有效、精确的固相萃取HPLC法测定人血浆中比阿培南的浓度。样品和内标物Vitamin B6经固相萃取后通过Capcell Pak C18柱进行分离。测定方法以0.05 mol/L 磷酸二氢钠(pH 5.7)-甲醇 (98:2, v/v)为流动相, 流速为1.0 mL/min, 检测波长为300 nm。比阿培南在0.04~50.00 μg/mL浓度范围内线性关系良好, 最低定量限可至0.04 μg/mL, 0.10、5.00和25.00 μg/mL三个浓度的提取回收率均在70%左右。这种测定方法成功地应用于12名健康志愿者单次静脉滴注三剂量 (150、300 和 600 mg) 比阿培南后的药动学研究。本方法具有良好的精密度和准确度, 并且保证样品处理后的稳定性, 因此能广泛应用于临床研究。

关键词: 比阿培南, 固相萃取, 高效液相色谱法, 药代动力学

Abstract:

Biapenem, a new parenteral carbapenem, has been widely used for treating bacterial infections. A simple, effective and accurate method based on solid-phase extraction (SPE) and HPLC was developed for the quantitative determination of biapenem in human plasma. Stability and feasibility of the method was validated through a series of experiments. Using Vitamin B6asan internal standard, analyte was separated on a Capcell Pak C18 column after SPE on Oasis hydrophilic-lipophilic balance (HLB) cartridge. The mobile phase was comprised of 0.05 mol/L NaH2PO4 (pH 5.7) and methanol (98:2, v/v) at a flow rate of 1.0 mL/min. Ultraviolet absorbance was measured at 300 nm. The calibration curve was linear in the concentration range of 0.04-50.00 μg/mL, and the lower limit of quantification was as low as 0.04 μg/mL. Recovery rates of biapenem at 0.10, 5.00, and 25.00 μg/mL were about 70%. The validated method has been successfully applied for quantifying biapenem in human samples and a pharmacokinetic study of 12 healthy volunteers who received three different doses (150, 300 and 600 mg) of biapenem by intravenous infusion. Our method has featured good accuracy and precision, and the processed sample was stable. Therefore, it can be propagated for clinical use.

Key words: Biapenem, Solid-phase extraction, High-performance liquid chromatography, Pharmacokinetic study

中图分类号:

R917

Supporting:

Foundation item: National Natural Science Foundation of China (Grant No.30973597).
^*Corresponding author. Tel./fax: 86-24-23925108

朱旭, 孙亚欣, 何晓静, 邱枫, 李岭, 肇丽梅^* . 固相萃取HPLC-UV法测定人血浆中比阿培南浓度及其药代动力学研究[J]. , DOI: 10.5246/jcps.2011.01.010.

Xu Zhu, Ya-Xin Sun, Xiao-Jing He, Feng Qiu, Jesse Ling Li, Li-Mei Zhao^* . HPLC-UV method with solid-phase extraction for the quantitative determination of biapenem in human plasma and its application in pharmacokinetic study[J]. , DOI: 10.5246/jcps.2011.01.010.

[1]	杨杰, 景彩芳, 李少创, 刘思彤, 李董明, 李钦青, 贺文彬. 复方党参颗粒制备工艺优化及4种成分的同时测定[J]. 中国药学(英文版), 2023, 32(8): 665-676.
[2]	杨雁芳, 韦玮, 张雷, 徐嵬, 杨秀伟. UPLC-MS/MS法测定都梁丸中37个成分在大鼠体内的药代动力学[J]. 中国药学(英文版), 2023, 32(7): 560-573.
[3]	朱愿超, 陈晨, 胡欣. 比阿培南在高龄老年患者中的应用[J]. 中国药学(英文版), 2023, 32(2): 145-152.
[4]	李莹, 文周, 刘永玲, 赵治兵, 王磊, 程泽能. 高效液相色谱法测定大鼠血浆中阿昔洛韦浓度及其与吉非替尼药物相互作用的研究[J]. 中国药学(英文版), 2021, 30(6): 495-504.
[5]	李晓娇, 栾树鑫, 张洪, 万洪泉, 陈红, 刘成娇, 刘畅, 丁艳华. 单剂量长效利培酮注射液在中国精神分裂症患者体内的药代动力学、药效学和安全性研究[J]. 中国药学(英文版), 2021, 30(3): 206-217.
[6]	周艳, 宋恒文, 邵志超, 尹博民, 付西美, 谢典佑, 韦利军. 一种新的细胞周期蛋白依赖性激酶(CDK)9抑制剂QHRD107对急性髓系白血病的临床前疗效[J]. 中国药学(英文版), 2021, 30(2): 146-156.
[7]	刘晓婷, 徐静娜, 肖坤, 郭强胜, 许旭. 固相萃取-定量核磁共振波谱法测定双黄连胶囊中的绿原酸[J]. 中国药学(英文版), 2020, 29(4): 227-235.
[8]	杨秀伟, 张友波, 徐嵬. 静脉和灌胃给予大鼠茴香酸对羟基苯乙酯的RP-HPLC法测定和药代动力学研究[J]. 中国药学(英文版), 2020, 29(11): 804-812.
[9]	杨辉, 胡小鹏, 杨晓勇, 刘航, 任亮, 王玮, 刘丽宏, 张小东. 肾移植术后糖皮质激素和他克莫司的药代动力学相互作用[J]. 中国药学(英文版), 2019, 28(4): 257-263.
[10]	刘鑫, 张波, 梅丹, 黄凯. HPLC-MS/MS法测定大鼠血浆中异绿原酸B浓度及其在药代动力学研究中的应用[J]. 中国药学(英文版), 2019, 28(3): 167-173.
[11]	张玲玲, 张慧文, 武世奎, 刘宏, 李静媛, 董馨, 夏慧敏, 王焕芸. UPLC-Q-Exactive-MS 同时测定三臣丸中六种活性成分的药代动力学研究[J]. 中国药学(英文版), 2019, 28(11): 812-824.
[12]	欧阳文鹃, 张亚兰, 徐平声, 戴智勇, 马虹英, 秦群. 国产注射用甲磺酸帕珠沙星在健康人体的药代动力学研究[J]. 中国药学(英文版), 2019, 28(1): 40-48.
[13]	常馨予, 郭桂明, 范峥, 王宏蕾, 刘洋, 韩丽娟. UPLC-MS/MS法测定黄芪桂枝五物汤在大鼠血浆中两种活性成分及药代动力学研究[J]. 中国药学(英文版), 2018, 27(4): 263-272.
[14]	姜华, 杨景明, 曹玲, 贾桂枝, 戴红良, 孟祥才. 高温胁迫对防风药材药代动力学和药效的影响[J]. 中国药学(英文版), 2018, 27(2): 109-115.
[15]	王环鑫, 孙亚欣, 徐善森, 路童, 陈亚南, 肇丽梅. 高效液相色谱法测定人血浆中游离拉莫三嗪的血药浓度[J]. 中国药学(英文版), 2018, 27(12): 832-839.