一测多评法测定热毒宁注射液中9种成分
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摘要
目的建立一测多评(QAMS)法测定热毒宁注射液中9种成分的分析方法,并与外标法进行比较,评价QAMS法用于热毒宁注射液质量控制的技术适应性和应用可行性。方法以热毒宁注射液为研究对象,以绿原酸、异绿原酸A和栀子苷为内参物,建立绿原酸与新绿原酸、隐绿原酸、咖啡酸间的相对校正因子(f),异绿原酸A与异绿原酸B、异绿原酸C间的f,栀子苷与断氧化马钱子苷间的f,比较该方法与外标法测定结果的差异,并对该方法进行再验证。结果热毒宁注射液中各成分的f分别为f绿原酸/新绿原酸=0.965、f绿原酸/隐绿原酸=0.991、f绿原酸/咖啡酸=0.555、f异绿原酸A/异绿原酸B=1.283、f异绿原酸A/异绿原酸C=1.129、f栀子苷/断氧化马钱子苷=1.030。QAMS法的计算结果与外标法的实测结果无显著性差异,再验证结果也无显著性差异,实验所得的f可信。结论 QAMS可以作为一种简便准确的质量评价模式用于热毒宁注射液多种成分的定量测定。
Objective To establish a quantitative analysis of multi-components with a single-marker(QAMS) method for the determination of the nine components in Reduning Injection(RI), comparing with the external standard method, and to evaluate the adaptation and application of QAMS method in the quality control of RI. Methods Chlorogenic acid, isochlorogenic acid A, and gardenoside were used as the internal reference substances. The relative correlation factors(f) of neochlorogenic acid, cryptochlorogenic acid, and caffeic acid to chlorogenic acid, isochlorogenic acid B and isochlorogenic acid C to isochlorogenic acid A, and secoxyloganin to gardenoside were calculated and established. The results were compared with those obtained by the external standard method. Results Within the linear ranges, the f values of chlorogenic acid to neochlorogenic acid, cryptochlorogenic acid, and caffeic acid were 0.965,0.991, and 0.555, respectively; isochlorogenic acid A to isochlorogenic acid B and isochlorogenic acid C were 1.283 and 1.129,respectively; jasminoidin to secoxyloganin was 1.030. The two methods did not show the significant difference in assay results.Conclusion The QAMS method is feasible and credible, and could be used to determine the multiple components in RI.
Objective To establish a quantitative analysis of multi-components with a single-marker(QAMS) method for the determination of the nine components in Reduning Injection(RI), comparing with the external standard method, and to evaluate the adaptation and application of QAMS method in the quality control of RI. Methods Chlorogenic acid, isochlorogenic acid A, and gardenoside were used as the internal reference substances. The relative correlation factors(f) of neochlorogenic acid, cryptochlorogenic acid, and caffeic acid to chlorogenic acid, isochlorogenic acid B and isochlorogenic acid C to isochlorogenic acid A, and secoxyloganin to gardenoside were calculated and established. The results were compared with those obtained by the external standard method. Results Within the linear ranges, the f values of chlorogenic acid to neochlorogenic acid, cryptochlorogenic acid, and caffeic acid were 0.965,0.991, and 0.555, respectively; isochlorogenic acid A to isochlorogenic acid B and isochlorogenic acid C were 1.283 and 1.129,respectively; jasminoidin to secoxyloganin was 1.030. The two methods did not show the significant difference in assay results.Conclusion The QAMS method is feasible and credible, and could be used to determine the multiple components in RI.
引文
[1]毕宇安,王振中,宋爱华,等.热毒宁注射液高效液相色谱指纹图谱研究及多成分定量分析[J].世界科学技术:中医药现代化,2010,12(2):298-303.
[2]匡艳辉,朱晶晶,王智民,等.一测多评法测定黄连中小檗碱、巴马汀、黄连碱、表小檗碱、药根碱含量[J].中国药学杂志,2009,44(5):390-394.
[3]孔晶晶,朱晶晶,王智民,等.一测多评法测定连翘中多种不同类型成分的含量[J].中国药学杂志,2010,35(17):1301-1304.
[4]尹萌,孟月兰,闻琍毓.关黄柏中生物碱类成分的“一测多评”[J].中草药,2011,42(6):1093-1096.
[5]谭玉柱,童婷婷,赵高琼,等.基于一测多评法对大黄地上部位提取物的质量控制研究[J].中草药,2013,44(9):1190-1194.
[6]宋永贵,张武岗,刘岩庭,等.一测多评法同时测定预知子中4种三萜皂苷[J].中草药,2012,43(7):1418-1421.
[7]蓝天凤,王晓,王岱杰,等.一测多评法测定丹参中4种丹参酮类成分[J].中草药,2012,43(12):2420-2423.
[8]林永强,徐丽华,王淑华,等.一测多评法同步测定银黄片中6种咖啡酰奎宁酸[J].中草药,2012,43(4):706-710.
[9]杨菲,冯伟红,王智民,等.一测多评法测定银黄制剂中4种黄酮类成分含量[J].中国药学杂志,2012,47(12):984-988.
[10]何兵,刘艳,杨世艳,等.HPLC一测多评法同时测定双青咽喉片中10种成分[J].中草药,2013,44(8):974-981.
[11]林青,匡艳辉,黄琳,等.一测多评法测定穿心莲及其制剂中内酯类成分[J].中草药,2012,43(12):2406-2411.
[12]陆兔林,石上梅,蔡宝昌,等.基于一测多评的中药多成分定量研究进展[J].中草药,2012,43(12):2525-2529.
[13]王智民,高慧敏,付雪涛,等.“一测多评”法中药质量评价模式方法学研究[J].中国中药杂志,2006,31(23):1925-1928.
[14]程丽丽,许妍妍,Nyirimigabo E,等.一测多评法测定乌头类药材中生物碱[J].现代药物与临床,2013,28(4):528-534.
[2]匡艳辉,朱晶晶,王智民,等.一测多评法测定黄连中小檗碱、巴马汀、黄连碱、表小檗碱、药根碱含量[J].中国药学杂志,2009,44(5):390-394.
[3]孔晶晶,朱晶晶,王智民,等.一测多评法测定连翘中多种不同类型成分的含量[J].中国药学杂志,2010,35(17):1301-1304.
[4]尹萌,孟月兰,闻琍毓.关黄柏中生物碱类成分的“一测多评”[J].中草药,2011,42(6):1093-1096.
[5]谭玉柱,童婷婷,赵高琼,等.基于一测多评法对大黄地上部位提取物的质量控制研究[J].中草药,2013,44(9):1190-1194.
[6]宋永贵,张武岗,刘岩庭,等.一测多评法同时测定预知子中4种三萜皂苷[J].中草药,2012,43(7):1418-1421.
[7]蓝天凤,王晓,王岱杰,等.一测多评法测定丹参中4种丹参酮类成分[J].中草药,2012,43(12):2420-2423.
[8]林永强,徐丽华,王淑华,等.一测多评法同步测定银黄片中6种咖啡酰奎宁酸[J].中草药,2012,43(4):706-710.
[9]杨菲,冯伟红,王智民,等.一测多评法测定银黄制剂中4种黄酮类成分含量[J].中国药学杂志,2012,47(12):984-988.
[10]何兵,刘艳,杨世艳,等.HPLC一测多评法同时测定双青咽喉片中10种成分[J].中草药,2013,44(8):974-981.
[11]林青,匡艳辉,黄琳,等.一测多评法测定穿心莲及其制剂中内酯类成分[J].中草药,2012,43(12):2406-2411.
[12]陆兔林,石上梅,蔡宝昌,等.基于一测多评的中药多成分定量研究进展[J].中草药,2012,43(12):2525-2529.
[13]王智民,高慧敏,付雪涛,等.“一测多评”法中药质量评价模式方法学研究[J].中国中药杂志,2006,31(23):1925-1928.
[14]程丽丽,许妍妍,Nyirimigabo E,等.一测多评法测定乌头类药材中生物碱[J].现代药物与临床,2013,28(4):528-534.