UPLC-MS/MS测定参芎葡萄糖注射液中阿拉伯糖、果糖、甘露糖和葡萄糖
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摘要
目的:建立超高效液相色谱-三重四级杆质谱联用仪(UPLC-MS/MS)法测定参芎葡萄糖注射液中阿拉伯糖、果糖、甘露糖、葡萄糖的含量测定方法,为科学评价参芎葡萄糖注射液的质量提供依据,为保障临床安全用药奠定基础。方法:采用国产GDX-403固相萃取柱净化,Waters ACQUITY UPLC BEH Xbridge Amide色谱柱(2.1 mm×100 mm,1.7μm),柱温35℃进行分析;[(0.1%氨水-乙腈)-(0.1%氨水-水)](85∶15)为流动相进行分离,流速0.3 mL·min-1,以超高效液相色谱-三重四级杆质谱联用仪(UPLC-MS/MS)测定参芎葡萄糖注射液中阿拉伯糖、甘露糖、果糖和葡萄糖含量。结果:建立了参芎葡萄糖注射液中阿拉伯糖、果糖、甘露糖、葡萄糖的含量测定方法,所测定的样品中和混合对照品中阿拉伯糖、果糖、甘露糖、葡萄糖相应的浓度范围与峰面积呈良好的线性关系,重复性、精密度良好,加样回收率分别为98.43%,102.13%,100.72%,101.75%,其RSD分别为2.4%和1.3%,3.1%,2.7%。5个批次参芎葡萄糖注射液中阿拉伯糖和甘露糖含量稳定。结论:该操作方法简便,专属性强,与总糖的含量测定相比更加科学稳定,可用于参芎葡萄糖注射液的质量控制。
Objective:To establish a method for determining arabinose,mannose,fructopyranose and amylaceum in Shenxiong glucose injection by UPLC-MS/MS,so as to provide the basis for the scientific evaluation of the quality of Shenxiong glucose injection,and lay a foundation for the safe use of drugs in clinic.Method:Domestic GDX-403 solid-phase extraction column was used to purify Waters ACQUITY UPLC BEH Xbridge Amide column(2.1 mm×100 mm,1.7 μm) at the column temperature of 35 ℃,and the mobile phase was 0.1%ammonia,0.1% acetonitrile-0.1% ammonia water and water 85∶15.The contents of arabinose,mannose,fructose and glucose in Shenxiong glucose injection were determined by UPLC-MS/MS with a flow rate of0.3 mL·min-1.Result:A method was established to determine arabinose,mannose,fructopyranose and amylaceum in Shenxiong glucose injection.The concentration range of arabinose,mannose,fructopyranose and amylaceum showed a good linear relationship with the peak area,with a good repeatability and precision.Recoveries were 98.43%,102.13%,100.72%,101.75%,and RSD were 2.4%,1.3%,3.1%,2.7%.Arabinose and mannose content were stable in five batches of Shenxiong glucose injection.Conclusion:The method is simple and specific.Compared with the determination of total sugar,the method is more scientific and stable,and can be used for the quality control of Shenxiong glucose injection.
Objective:To establish a method for determining arabinose,mannose,fructopyranose and amylaceum in Shenxiong glucose injection by UPLC-MS/MS,so as to provide the basis for the scientific evaluation of the quality of Shenxiong glucose injection,and lay a foundation for the safe use of drugs in clinic.Method:Domestic GDX-403 solid-phase extraction column was used to purify Waters ACQUITY UPLC BEH Xbridge Amide column(2.1 mm×100 mm,1.7 μm) at the column temperature of 35 ℃,and the mobile phase was 0.1%ammonia,0.1% acetonitrile-0.1% ammonia water and water 85∶15.The contents of arabinose,mannose,fructose and glucose in Shenxiong glucose injection were determined by UPLC-MS/MS with a flow rate of0.3 mL·min-1.Result:A method was established to determine arabinose,mannose,fructopyranose and amylaceum in Shenxiong glucose injection.The concentration range of arabinose,mannose,fructopyranose and amylaceum showed a good linear relationship with the peak area,with a good repeatability and precision.Recoveries were 98.43%,102.13%,100.72%,101.75%,and RSD were 2.4%,1.3%,3.1%,2.7%.Arabinose and mannose content were stable in five batches of Shenxiong glucose injection.Conclusion:The method is simple and specific.Compared with the determination of total sugar,the method is more scientific and stable,and can be used for the quality control of Shenxiong glucose injection.
引文
[1]杨洋,刘兰,王文华,等.参芎葡萄糖注射液对H2O2诱导的HUVEC细胞氧化损伤的保护作用[J].中国实验方剂学杂志,2017,23(1):163-168.
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[4]王桂倩,谢雁鸣,刘峘,等.真实世界的参芎葡萄糖注射液治疗缺血性脑血管病临床联合用药特征分析[J].中国中药杂志,2017,42(14):2808-2813.
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[7]郑林,庞秀清,兰燕宇,等.UFLC法同时测定参芎葡萄糖注射液中6种主要成分[J].中成药,2012,34(7):1276-1279.
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[9]黄利,葛婷,夏蕴琼,等.HPLC-ELSD同时测定丹参注射液中4种糖类成分的含量[J].中国现代中药,2013,15(6):500-502.
[10]陈华.Xbridge Amide色谱柱测定果糖注射液中果糖含量[J].药物生物技术,2012,19(6):525-526.
[11]张红霞,张加余,张倩,等.高效液相-蒸发光散射检测法测定清开灵注射液中木糖等4种糖的含量[J].中国药学杂志,2013,48(14):1183-1186.
[12]许妍,吴毅,赵雯,等.参麦注射液中糖类成分含量测定研究[J].齐鲁药事,2011,30(11):636-638.
[13]朱迪,谭丹,侯靖宇,等.紫外分光光度法和蒽酮-硫酸法测定参芎葡萄糖注射液中总糖含量[J].贵阳医学院学报,2015,40(4):349-351,355.
[14]陈农,丁宁,彭国平,等.两种方法测定丹参滴注液糖类含量[J].医药导报,2013,32(5):672-674.
[15]李萌,刘新国,吴金虎,等.前愈复方中多糖成分的提取工艺优选[J].中国医院药学杂志,2011,31(24):2018-2021.
[16]阮鸣.冠心宁注射液中大类成分的含量测定[J].南京晓庄学院学报,2013,29(3):71-75.
[17]毕宇安,王雪,张伟,等.热毒宁注射液中糖类成分的HPLC-ELSD法测定[J].时珍国医国药,2015,26(5):1070-1072.
[18]董玮,陈加罡,陆斌.HPLC-RID法测定转化糖电解质注射液中果糖和葡萄糖含量[J].中国药师,2014,17(11):1883-1885.
[2]姚卫.高血压与心脑血管疾病研究综述[J].中外医疗,2010,29(14):184-184.
[3]王文华,杨洋,吴琼,等.参芎葡萄糖注射液的丹参组分对小鼠细胞色素P450的影响[J].中国实验方剂学杂志,2016,22(22):150-153.
[4]王桂倩,谢雁鸣,刘峘,等.真实世界的参芎葡萄糖注射液治疗缺血性脑血管病临床联合用药特征分析[J].中国中药杂志,2017,42(14):2808-2813.
[5]陈兴坚,刘建红.参芎葡萄糖注射液的临床应用进展[J].中国实用医药,2010,5(13):247-249.
[6]李达文,龚惠,叶勇,等.参芎葡萄糖注射液对缺血再灌注损伤心肌的保护作用[J].中国分子心脏病学杂志,2012,12(1):51-56.
[7]郑林,庞秀清,兰燕宇,等.UFLC法同时测定参芎葡萄糖注射液中6种主要成分[J].中成药,2012,34(7):1276-1279.
[8]郑林,庞秀清,黄勇,等.参芎葡萄糖注射液的UFLC指纹图谱研究[J].中国医药工业杂志,2013,44(6):611-614.
[9]黄利,葛婷,夏蕴琼,等.HPLC-ELSD同时测定丹参注射液中4种糖类成分的含量[J].中国现代中药,2013,15(6):500-502.
[10]陈华.Xbridge Amide色谱柱测定果糖注射液中果糖含量[J].药物生物技术,2012,19(6):525-526.
[11]张红霞,张加余,张倩,等.高效液相-蒸发光散射检测法测定清开灵注射液中木糖等4种糖的含量[J].中国药学杂志,2013,48(14):1183-1186.
[12]许妍,吴毅,赵雯,等.参麦注射液中糖类成分含量测定研究[J].齐鲁药事,2011,30(11):636-638.
[13]朱迪,谭丹,侯靖宇,等.紫外分光光度法和蒽酮-硫酸法测定参芎葡萄糖注射液中总糖含量[J].贵阳医学院学报,2015,40(4):349-351,355.
[14]陈农,丁宁,彭国平,等.两种方法测定丹参滴注液糖类含量[J].医药导报,2013,32(5):672-674.
[15]李萌,刘新国,吴金虎,等.前愈复方中多糖成分的提取工艺优选[J].中国医院药学杂志,2011,31(24):2018-2021.
[16]阮鸣.冠心宁注射液中大类成分的含量测定[J].南京晓庄学院学报,2013,29(3):71-75.
[17]毕宇安,王雪,张伟,等.热毒宁注射液中糖类成分的HPLC-ELSD法测定[J].时珍国医国药,2015,26(5):1070-1072.
[18]董玮,陈加罡,陆斌.HPLC-RID法测定转化糖电解质注射液中果糖和葡萄糖含量[J].中国药师,2014,17(11):1883-1885.