文章摘要
赵映淑,王巨才,曹锋,刘春,陈叶兰.HPLC-MS/MS法考察水黄皮素在SD大鼠体内的药代动力学特征[J].中国药事,2024,38(1):82-88
HPLC-MS/MS法考察水黄皮素在SD大鼠体内的药代动力学特征
Investigate of Pharmacokinetics of Karanjin in SD Rats by HPLC-MS/MS
投稿时间:2023-02-22  
DOI:10.16153/j.1002-7777.2024.01.011
中文关键词: 水黄皮素  含量测定  液质联用  SD大鼠  血浆  药代动力学
英文关键词: karanjin  content determination  HPLC-MS/MS  SD rats  plasma  pharmacokinetics
基金项目:海南省自然科学基金面上项目(编号 819MS105)
作者单位
赵映淑 海南省药品检验所安全性评价研究中心海口 570216 
王巨才 海南省药品检验所安全性评价研究中心海口 570216 
曹锋 海南药物研究所有限责任公司海口 571100 
刘春 海南省药品检验所安全性评价研究中心海口 570216 
陈叶兰 海南省药品检验所安全性评价研究中心海口 570216 
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中文摘要:
      目的:建立大鼠血浆中水黄皮素的定量分析方法,并对其药代动力学进行研究。方法:通过灌胃给予SD大鼠水黄皮素(10 mg·kg-1),血浆样品经蛋白沉淀法处理后进行HPLC-MS/MS定量分析,以五味子醇甲为内标,采用Agilent Poroshell 120 EC-C18(50 mm×3.0 mm,2.7 μm)色谱柱,乙腈(A)-0.1%甲酸溶液(B)为流动相,流速0.3 mL·min-1,梯度洗脱;采用电喷雾离子源(ESI),正离子多反应监测模式(MRM)扫描,水黄皮素[M+H]+ m/z 293.1→277.0,五味子醇甲[M+H]+ m/z433.2→384.2;使用DAS软件计算相关药代动力学参数。结果:在1.5625~1600 ng·mL-1浓度范围内,水黄皮素线性关系良好(r=0.9997),定量下限为1.5625 ng·mL-1,精密度RSD和准确度RE均小于20%;低、中、高质控样品精密度RSD和准确度RE均小于15%,提取回收率在91.70%~100.28%,基质效应在88.35%~97.55%,稳定性RSD均小于15%。水黄皮素在雌性SD大鼠体内Tmax、t1/2、Cmax和AUC0→t分别为3 h、1.95 h、1214.85 ng·mL-1和11920.43 ng·mL-1·h;在雄性SD大鼠体内Tmax、t1/2、Cmax和AUC0→t分别为3 h、1.19 h、1221.57 ng·mL-1和9983.40 ng·mL-1·h。结论:所建方法符合生物样品定量分析的基本要求,可用于水黄皮素在大鼠血浆中的含量测定及其药代动力学评价;水黄皮素在雌性SD大鼠体内的生物利用度更高。
英文摘要:
      Objective: To establish a quantitative analysis method for the determination of karanjin in ratplasma and study its pharmacokinetics. Methods: SD rats were intragastrically administered with karanjin (10mg·kg-1). The plasma samples were pretreated by protein precipitation method and then detected quantitativelyby HPLC-MS/MS. Schisandrin was employed as an internal standard. The separation was performed on anAgilent Poroshell 120 EC-C18 (50 mm×3.0 mm, 2.7 μm) column with acetonitrile (A)-0.1% methanoic acid solution (B) as mobile phase at a flow rate of 0.3 mL·min-1. Electrospray ionization (ESI) source and positiveion multiple reaction monitoring (MRM) mode were used for scanning, and the results showed that karanjin[M+H]+ m/z 293.1→277.0, schisandrin[M+H]+ m/z 433.2→384.2; the pharmacokinetic parameters werecalculated by DAS software. Results: In the range of 1.5625-1600 ng·mL-1, karanjin showed a good linerrelationship in plasma (r=0.9997), with a low limit of quantification of 1.5625 ng·mL-1, precision (RSD) andaccuracy (RE) were less than 20%. The precision RSD and accuracy RE of low medium and high qualitycontrol samples were less than 15%. The Tmax, t1/2, Cmax and AUC0→t of female SD rats were 3 h, 1.95 h, 1214.85 ng·mL-1and 11920.43 ng·mL-1·h respectively, while that of male rats were 3 h, 1.19 h, 1221.57 ng·mL-1 and 9983.40ng·mL-1·h respectively. Conclusion: The established method meets the basic requirements of quantitative analysisof biological samples, and can be used for the content determination and pharmacokinetic evaluation of karanjinin rat plasma. The bioavailability of karanjin in female SD rats is higher.
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