一测多评法同时测定复方苦参注射液中7种成分
|
摘要
目的建立一测多评法同时测定复方苦参注射液中生物碱和黄酮类7种成分,验证此方法在复方苦参注射液中应用的可靠性和方法适用性。方法以氧化苦参碱为内参物,建立与其他6种成分(氧化槐果碱、槐定碱、N-甲基野靛碱、苦参碱、槐果碱、三叶豆紫檀苷)的相对校正因子进行一测多评。同时采用外标法对这7种成分进行含量测定,通过比较2种方法的结果来验证一测多评法的准确性和可行性。结果氧化槐果碱、槐定碱、N-甲基野靛碱、苦参碱、槐果碱、三叶豆紫檀苷的f值分别为0.789,1.872,0.408,1.533,0.953,0.409;2种计算结果无显著差异。结论一测多评质量评价模式可用于复方苦参注射液中多指标成分的同步质量评价。
OBJECTIVE To establish a new method for quantitative analysis on multi-components with a single marker(QAMS) for simultaneous determination of 7 main constituents including alkaloid and flavone in Compound Kushen Injection(CKI) and to validate its feasibility and technical adaptability in analysis of CKI. METHODS Oxymatrine was used as the internal reference substances and the relative correlation factors(f) of oxysophocarpine, sophoridine, N-methylcytisine,matrine, sophocarpine, trifolirhizin were calculated. RESULTS The relative correlation factors(f) were 0.789, 1.872, 0.408,1.533, 0.953, 0.409 for oxysophocarpine, sophoridine, N-methylcytisine, matrine, sophocarpine and trifolirhizin respectively. The determination results were compared with those obtained by the external standard method. There was no significant difference in assay results between the QAMS method and the external standard method. CONCLUSION The QAMS method was reliable and can be used for quality control of CKI.
OBJECTIVE To establish a new method for quantitative analysis on multi-components with a single marker(QAMS) for simultaneous determination of 7 main constituents including alkaloid and flavone in Compound Kushen Injection(CKI) and to validate its feasibility and technical adaptability in analysis of CKI. METHODS Oxymatrine was used as the internal reference substances and the relative correlation factors(f) of oxysophocarpine, sophoridine, N-methylcytisine,matrine, sophocarpine, trifolirhizin were calculated. RESULTS The relative correlation factors(f) were 0.789, 1.872, 0.408,1.533, 0.953, 0.409 for oxysophocarpine, sophoridine, N-methylcytisine, matrine, sophocarpine and trifolirhizin respectively. The determination results were compared with those obtained by the external standard method. There was no significant difference in assay results between the QAMS method and the external standard method. CONCLUSION The QAMS method was reliable and can be used for quality control of CKI.
引文
[1]中华人民共和国卫生部药品标准[S].中药成方制剂.第14册,1995,WS3-B-2752-97.
[2]HUANG Y X,GUO Y M,SANG X X,et al.Systematic review of efficacy of compound kushen injection in relieving cancer-related pain[J].Chin J Exp Tradit Med Form(中国实验方剂学杂志),2016,22(2):172-179.
[3]MA Y,ZHANG Q W,WANG Z M,et al.Advance in study on compound kushen injection[J].Chin J Exp Tradit Med Form(中国实验方剂学杂志),2012,18(23):342-345.
[4]LIN L Z,ZHOU D H,CHEN Y,et al.Experimental study of anti-tumor effect of Compound Radix Sophorae Flavescentis injection on lung cancer cells and hepatic carcinoma cells[J].Tradit Chin Drug Res Clin Pharm(中药新药与临床药理),2009,20(1):21-23.
[5]MA Y,ZHANG Q W,WANG Z M,et al.Advance in study on compound Kushen injection[J].Chin J Exp Tradit Med Form(中国实验方剂学杂志),2012,18(23):342-344.
[6]ZHOU X M,SHI C.Simultaneous determination of 3alkaloids in compound kushen injection by HPLC[J].China JChin Mater Med(中国中药杂志),2004,29(7):705-706.
[7]CHEN C,QU H B,HAO R C,et al.Ion-pair RP-HPLCsimultaneous determination of four alkaloids in compound kushen injection[J].Chin J Pharm Anal(药物分析杂志),2012,32(6):1006-1009.
[8]NONG X W,LIANG B L,LI Y,et al.Quantitative analysis of Zhuang medicine Ilex Pubescens Formula granules by QAMS[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(8):1118-1121.
[9]ZHU J J,WANG Z M,GAO H M,et al.Advances on quality evaluation of Chinese Materia Medica by QAMS[J].Chin JExp Tradit Med Form(中国实验方剂学杂志),2016,22(16):220-228.
[10]ZHANG M M,CHAI Y,REN A N,et al.Simultaneous determination of 10 constituents in Qingqing granule by quantitative analysis of multi-components by single marker[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(3):318-323.
[2]HUANG Y X,GUO Y M,SANG X X,et al.Systematic review of efficacy of compound kushen injection in relieving cancer-related pain[J].Chin J Exp Tradit Med Form(中国实验方剂学杂志),2016,22(2):172-179.
[3]MA Y,ZHANG Q W,WANG Z M,et al.Advance in study on compound kushen injection[J].Chin J Exp Tradit Med Form(中国实验方剂学杂志),2012,18(23):342-345.
[4]LIN L Z,ZHOU D H,CHEN Y,et al.Experimental study of anti-tumor effect of Compound Radix Sophorae Flavescentis injection on lung cancer cells and hepatic carcinoma cells[J].Tradit Chin Drug Res Clin Pharm(中药新药与临床药理),2009,20(1):21-23.
[5]MA Y,ZHANG Q W,WANG Z M,et al.Advance in study on compound Kushen injection[J].Chin J Exp Tradit Med Form(中国实验方剂学杂志),2012,18(23):342-344.
[6]ZHOU X M,SHI C.Simultaneous determination of 3alkaloids in compound kushen injection by HPLC[J].China JChin Mater Med(中国中药杂志),2004,29(7):705-706.
[7]CHEN C,QU H B,HAO R C,et al.Ion-pair RP-HPLCsimultaneous determination of four alkaloids in compound kushen injection[J].Chin J Pharm Anal(药物分析杂志),2012,32(6):1006-1009.
[8]NONG X W,LIANG B L,LI Y,et al.Quantitative analysis of Zhuang medicine Ilex Pubescens Formula granules by QAMS[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(8):1118-1121.
[9]ZHU J J,WANG Z M,GAO H M,et al.Advances on quality evaluation of Chinese Materia Medica by QAMS[J].Chin JExp Tradit Med Form(中国实验方剂学杂志),2016,22(16):220-228.
[10]ZHANG M M,CHAI Y,REN A N,et al.Simultaneous determination of 10 constituents in Qingqing granule by quantitative analysis of multi-components by single marker[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(3):318-323.