线性指纹定量法评价苦碟子注射液三波长融合指纹图谱
|
摘要
目的建立以线性指纹定量法(余弦法)评价苦碟子注射液三波长高效液相色谱融合指纹图谱,同时结合5组分定量鉴别苦碟子注射液质量的分析方法,并分析指纹图谱与体外抗氧化活性的相关性,综合提高注射剂质量控制。方法建立苦碟子注射液三波长融合指纹图谱和测定5组分含量,用5组分定量结果和定量指纹图谱共同评价30批苦碟子注射液质量,并考察30批苦碟子注射液对1,1-二苯基-2-三硝基苯肼自由基清除能力,探寻指纹图谱与体外抗氧化活性之间的谱-效关系。结果建立了苦碟子注射液三波长高效液相色谱融合指纹图谱,以线性指纹定量法(余弦法)评价30批样品全部合格,体外抗氧化试验显示326 nm下17个共有指纹峰中,11个共有峰面积和抗氧化活性正相关。结论三波长高效液相色谱融合指纹图谱可以全面揭示苦碟子注射液特征吸收波长下的指纹信息,该方法为科学评价与有效控制苦碟子注射液的质量提供了参考。
Objective To evaluate the three-wavelength high performance liquid chromatographic fingerprints of Kudiezi injection using linear fingerprint quantitative method-cosine method combined with simutaneous determination of five components,and analyze the relationship between fingerprint and in vitro antioxidant activity.Comprehensively improve quality control.Methods Column:CAPCELL PAK(MG) C18 column(4.6 mm×250 mm,5 μm);mobile phase:A is a 0.2% phosphoric acid aqueous solution(containing 30 mmol/L sodium dihydrogen phosphate),B is acetonitrile-absolute ethanol-water( 82∶10∶8,v/v,containing 0.24% phosphoric acid,gradient elution;column temperature was controlled at 35℃;injection volume was 10μL;Chromatographic fingerprints were established at 215,265,326 and 340 nm.5 components of Kudiezi injection was determined by stand curve method.The quality of 30 batches of Kudiezi injection was evaluated by quantitative results of 5 components and quantitative fingerprints.The scavenging activity of 1,1-diphenyl-2-trinitrophenylhydrazine on 30 batches of Kudiezi injection was also investigated.The spectrum-effect relationship between its fingerprint and in vitro antioxidant activity was studied.Results A three-wavelength high performance liquid chromatographic fingerprint of Kudiezi injection was established.All the 30 batches of samples were evaluated by the linear fingerprinting method-cosine method.In vitro antioxidant test showed that among the 17 common fingerprint peaks at 326 nm,the area of 11 common peaks is positively correlated with antioxidant activity.Conclusion The three-wavelength high performance liquid chromatography fingerprint can fully represent the fingerprint information of the characteristic absorption wavelength of Kudiezi injection.This method provides a reference for scientific evaluation and effective control of the quality of Kudiezi injection.
Objective To evaluate the three-wavelength high performance liquid chromatographic fingerprints of Kudiezi injection using linear fingerprint quantitative method-cosine method combined with simutaneous determination of five components,and analyze the relationship between fingerprint and in vitro antioxidant activity.Comprehensively improve quality control.Methods Column:CAPCELL PAK(MG) C18 column(4.6 mm×250 mm,5 μm);mobile phase:A is a 0.2% phosphoric acid aqueous solution(containing 30 mmol/L sodium dihydrogen phosphate),B is acetonitrile-absolute ethanol-water( 82∶10∶8,v/v,containing 0.24% phosphoric acid,gradient elution;column temperature was controlled at 35℃;injection volume was 10μL;Chromatographic fingerprints were established at 215,265,326 and 340 nm.5 components of Kudiezi injection was determined by stand curve method.The quality of 30 batches of Kudiezi injection was evaluated by quantitative results of 5 components and quantitative fingerprints.The scavenging activity of 1,1-diphenyl-2-trinitrophenylhydrazine on 30 batches of Kudiezi injection was also investigated.The spectrum-effect relationship between its fingerprint and in vitro antioxidant activity was studied.Results A three-wavelength high performance liquid chromatographic fingerprint of Kudiezi injection was established.All the 30 batches of samples were evaluated by the linear fingerprinting method-cosine method.In vitro antioxidant test showed that among the 17 common fingerprint peaks at 326 nm,the area of 11 common peaks is positively correlated with antioxidant activity.Conclusion The three-wavelength high performance liquid chromatography fingerprint can fully represent the fingerprint information of the characteristic absorption wavelength of Kudiezi injection.This method provides a reference for scientific evaluation and effective control of the quality of Kudiezi injection.
引文
[1] 刘沛.苦碟子注射液的药理作用和临床应用研究进展[J].中国药师,2008,11(12):1445-1447.
[2] 刘颖,卢建秋,张加余,等.苦碟子药材及其注射液中化学成分的HPLC-ESI-MS～n分析[J].中国中药杂志,2013,38(16):2675-2681.
[3] 吴晶晶,李天祥,李庆和,等.抱茎苦荬菜化学成分和药理作用的研究进展[J].天津中医药,2015,32(4):247-252.
[4] 黎元元,李志强,谢雁鸣.基于循证药学的悦安欣○R苦碟子注射液上市后安全性研究[J].世界中医药,2014,9(09):1120-1123,1127.
[5] 廖汉雄,黄德欢,张晓元.中药注射剂质量控制标准对药物不良反应的影响[J].中药材,2012,35(05):836-839.
[6] 刘睿,马思萌,孙璐,等.HPLC-DAD法同时测定苦碟子注射液中10种核苷类成分[J].中草药,2013,44(18):2542-2546.
[7] 马思萌,刘睿,任晓亮,等.HPLC-DAD同时测定苦碟子注射液中7种黄酮类成分含量[J].中国实验方剂学杂志,2014,20(7):63-66.
[8] 陈英红,姜瑞芝,罗浩铭,等.苦碟子药材HPLC指纹图谱研究[J].中成药,2008,30(11):1569-1571.
[9] 孙国祥,王璐,侯志飞.注射用苦碟子HPLC数字化指纹图谱研究[J].中成药,2008,30(6):784-789.
[10] 孙国祥,董玉霞,慕善学,等.苦碟子注射液毛细管电泳指纹图谱[J].沈阳药科大学学报,2006,23(4):233-236.
[11] 聂磊,胡震,罗国安,等.中药指纹图谱的融合技术[J].分析化学,2005(6):898.
[12] 马迪迪,巩丹丹,孙国祥,等.三波长融合指纹图谱结合6组分定量和主成分分析评价银翘解毒片的质量[J].色谱,2017,35(7):741-747.
[13] FANG Y Z,YANG S,WU G Y.Free radicals,antioxidants and nutrition[J].Nutrition,2002,18(10):872-879.
[14] CAI Y Z,LUO Q,SUN M,et al.Antioxidant activity and phenolic compounds of 112 traditional Chinese medicinal plants associated with anticancer.[J].Life sciences,2004,74(17):84-2157.
[15] 罗浩铭,韩威,王颖,等.苦碟子注射液抗氧化成分的分离与活性评价研究[J].天然产物研究与开发,2013,25(5):672-675.
[16] 李秋红,李廷利,黄莉莉,等.中药抗氧化的作用机理及评价方法研究进展[J].时珍国医国药,2008,19(5):1257-1258.
[17] 刘睿,孙璐,赵雯,等.HPLC同时测定苦碟子注射液中单咖啡酰基酒石酸、咖啡酸、绿原酸、阿魏酸、菊苣酸的含量[J].中国中药杂志,2013,38(19):3287-3290.
[2] 刘颖,卢建秋,张加余,等.苦碟子药材及其注射液中化学成分的HPLC-ESI-MS～n分析[J].中国中药杂志,2013,38(16):2675-2681.
[3] 吴晶晶,李天祥,李庆和,等.抱茎苦荬菜化学成分和药理作用的研究进展[J].天津中医药,2015,32(4):247-252.
[4] 黎元元,李志强,谢雁鸣.基于循证药学的悦安欣○R苦碟子注射液上市后安全性研究[J].世界中医药,2014,9(09):1120-1123,1127.
[5] 廖汉雄,黄德欢,张晓元.中药注射剂质量控制标准对药物不良反应的影响[J].中药材,2012,35(05):836-839.
[6] 刘睿,马思萌,孙璐,等.HPLC-DAD法同时测定苦碟子注射液中10种核苷类成分[J].中草药,2013,44(18):2542-2546.
[7] 马思萌,刘睿,任晓亮,等.HPLC-DAD同时测定苦碟子注射液中7种黄酮类成分含量[J].中国实验方剂学杂志,2014,20(7):63-66.
[8] 陈英红,姜瑞芝,罗浩铭,等.苦碟子药材HPLC指纹图谱研究[J].中成药,2008,30(11):1569-1571.
[9] 孙国祥,王璐,侯志飞.注射用苦碟子HPLC数字化指纹图谱研究[J].中成药,2008,30(6):784-789.
[10] 孙国祥,董玉霞,慕善学,等.苦碟子注射液毛细管电泳指纹图谱[J].沈阳药科大学学报,2006,23(4):233-236.
[11] 聂磊,胡震,罗国安,等.中药指纹图谱的融合技术[J].分析化学,2005(6):898.
[12] 马迪迪,巩丹丹,孙国祥,等.三波长融合指纹图谱结合6组分定量和主成分分析评价银翘解毒片的质量[J].色谱,2017,35(7):741-747.
[13] FANG Y Z,YANG S,WU G Y.Free radicals,antioxidants and nutrition[J].Nutrition,2002,18(10):872-879.
[14] CAI Y Z,LUO Q,SUN M,et al.Antioxidant activity and phenolic compounds of 112 traditional Chinese medicinal plants associated with anticancer.[J].Life sciences,2004,74(17):84-2157.
[15] 罗浩铭,韩威,王颖,等.苦碟子注射液抗氧化成分的分离与活性评价研究[J].天然产物研究与开发,2013,25(5):672-675.
[16] 李秋红,李廷利,黄莉莉,等.中药抗氧化的作用机理及评价方法研究进展[J].时珍国医国药,2008,19(5):1257-1258.
[17] 刘睿,孙璐,赵雯,等.HPLC同时测定苦碟子注射液中单咖啡酰基酒石酸、咖啡酸、绿原酸、阿魏酸、菊苣酸的含量[J].中国中药杂志,2013,38(19):3287-3290.
© 2004-2018 中国地质图书馆版权所有 京ICP备05064691号 京公网安备11010802017129号 地址：北京市海淀区学院路29号 邮编：100083 电话：办公室：(+86 10)66554848；文献借阅、咨询服务、科技查新：66554700 |