生脉注射液UPLC特征指纹图谱及11种成分定量分析
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摘要
目的:建立生脉注射液UPLC指纹图谱及多成分含量测定方法,测定人参皂苷Rb_1、麦冬皂苷D、五味子醇甲等11种活性成分的含量,为提升生脉注射液的质量标准提供实用可靠的方法。方法:采用超高效液相色谱-二极管阵列检测器(UPLC-DAD)法,使用Waters RP18色谱柱(100 mm×2.1 mm,1.7μm),以乙腈-水为流动相,梯度洗脱,流速为0.3 mL·min~(-1),柱温为40℃,全波长扫描(190～400 nm)。选取五味子醇甲为参照峰,并使用中药色谱指纹图谱相似度评价系统对指纹图谱进行相似性评价。结果:分析5厂家9批次生脉注射液指纹图谱,相似度均大于0.91,标定共有峰44个,对其中11个色谱峰进行了定性定量研究,各项方法学考察结果均符合测试要求。结论:所建立的UPLC指纹图谱分离效果良好,特征性强,方法稳定简单,基本能够反映生脉注射液的整体化学成分特征,结合多种活性成分同时测定的含量测定方法,更加客观全面地对该药进行质量控制,同时可为中药注射液安全性使用起一定的提示作用。
Objective:To establish UPLC fingerprints and method for simultaneous determination of eleven components in Shengmai Injection,such as ginsenoside Rb1,Ophiopogon japonicus D,Schisandrin,and provide a practical and reliable method to improve the quality standard of Shengmai Injection.Methods:By the technology of UPLC-DAD,the analysis was carried out on a Waters RP18 column(100 mm×2.1 mm,1.7 μm)with gradient elution of acetonitrile(A)-water(B)at a flow rate of 0.3 mL·min~(-1) with full-wavelength scanning(190-400 nm).The column temperature was 40℃.Schisandrin was selected as the reference peak.The UPLC fingerprints were analyzed and the similarity was evaluated with Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine.Results:The fingerprints of 9 batches of Shengmai injections from 5 manufacturers were all more than 0.91,and 44 common peaks were calibrated.The 11 peaks were qualitatively and quantitatively studied.The methodological investigation results were all in accordance with the testing requirements.Conclusion:The UPLC fingerprints established have a good separation effect,with strong characteristics.The method is stable and simple.It can basically reflect the overall chemical composition of Shengmai Injection.Combined with the determination method of simultaneous quantification of various active ingredients,the UPLC fingerprint is more objective and comprehensive and can provide warnings for the safe use of Chinese medicine injections.
Objective:To establish UPLC fingerprints and method for simultaneous determination of eleven components in Shengmai Injection,such as ginsenoside Rb1,Ophiopogon japonicus D,Schisandrin,and provide a practical and reliable method to improve the quality standard of Shengmai Injection.Methods:By the technology of UPLC-DAD,the analysis was carried out on a Waters RP18 column(100 mm×2.1 mm,1.7 μm)with gradient elution of acetonitrile(A)-water(B)at a flow rate of 0.3 mL·min~(-1) with full-wavelength scanning(190-400 nm).The column temperature was 40℃.Schisandrin was selected as the reference peak.The UPLC fingerprints were analyzed and the similarity was evaluated with Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine.Results:The fingerprints of 9 batches of Shengmai injections from 5 manufacturers were all more than 0.91,and 44 common peaks were calibrated.The 11 peaks were qualitatively and quantitatively studied.The methodological investigation results were all in accordance with the testing requirements.Conclusion:The UPLC fingerprints established have a good separation effect,with strong characteristics.The method is stable and simple.It can basically reflect the overall chemical composition of Shengmai Injection.Combined with the determination method of simultaneous quantification of various active ingredients,the UPLC fingerprint is more objective and comprehensive and can provide warnings for the safe use of Chinese medicine injections.
引文
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[15] 郭青,吴晓燕,史清水,等.中药注射剂质量评价的有关研究思路、方法和建议[J].药物评价研究,2010,33(5):351-360.
[16] 陈健,陈启龙,苏式兵.中医药精准医疗的思考与探索[J].世界科学技术:中医药现代化,2016,18(4):557-562.
[2] 徐淑华,刘生友.生脉注射液的药理作用研究进展[J].中国药事,2010,24(4):405-407.
[3] 赖江龙,王雁,陈吉婷.益气扶正、化瘀解毒法治疗脓毒症合并凝血功能障碍临床研究[J].亚太传统医药,2017,13(20):121-122.
[4] 郑笑为,汪祺,于建东,等.生脉注射液HPLC指纹图谱的建立[J].药物分析杂志,2012,32(8):1471-1475.
[5] 夏晶,王钢力,季申,等.HPLC测定生脉注射液中4种成分的含量[J].中成药,2006,28(1):27-31.
[6] 董晓茜,唐思,杨瑞,等.生脉注射液的UPLC特征指纹图谱研究[J].中华中医药学刊,2015,33(5):1067-1069.
[7] 汪祺,郑笑为,于健东,等.生脉注射液超高效液相色谱指纹图谱的建立及特征成分分析[J].药物分析杂志,2012,32(10):1813-1817.
[8] BAEK K S,Yi Y S,SON Y J,et al.In vitro and in vivo anti-inflammatory activities of Korean Red Ginseng-derived components[J].J Ginseng Res,2016,40(4):437.
[9] 孟晨,袁彩华,张晨晨,等.麦冬皂苷D通过减轻内质网应激对阿霉素所致心肌损伤产生保护作用[J].药学学报,2014,49(8):1117-1123.
[10] 吴伦,陈晓宇,于浩然,等.五味子醇甲的抗炎免疫作用研究[J].现代中药研究与实践,2017,31(5):18-21.
[11] 林苏娜,余楚钦,林华庆,等.UPLC测定参麦注射液中人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1的含量[J].中国实验方剂学杂志,2014,20(8):48-50.
[12] 巩克民,赵怀清,张鹏威.RP-HPLC法测定麦冬中麦冬皂苷D’的含量[J].分析仪器,2014(2):73-76.
[13] 刘芷,贾英,赵旭,等.五味子的UPLC指纹图谱研究[J].中草药,2014,45(11):1631-1633.
[14] 马新飞,郭盛,朱邵晴,等.基于HPLC指纹图谱及多元功效成分定量分析的南五味子药材质量标准提升研究[J].中国现代中药,2018,20(3):293-297.
[15] 郭青,吴晓燕,史清水,等.中药注射剂质量评价的有关研究思路、方法和建议[J].药物评价研究,2010,33(5):351-360.
[16] 陈健,陈启龙,苏式兵.中医药精准医疗的思考与探索[J].世界科学技术:中医药现代化,2016,18(4):557-562.