| 引用本文: | 牛天增,陈士林,王红芳,赵建斌,海丽娜,秦文杰.一测多评法同时测定复方苦参注射液中7种成分[J].中国现代应用药学,2019,36(10):1187-1192. |
| NIU Tianzeng,CHEN Shilin,WANG Hongfang,ZHAO Jianbin,HAI Lina,QIN Wenjie.Simultaneous Determination of Seven Constituents in Compound Kushen Injection with Quantitative Analysis of Multi-components by Single-marker[J].Chin J Mod Appl Pharm(中国现代应用药学),2019,36(10):1187-1192. |
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| 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。 |
| 关键词: 一测多评法 相对校正因子 复方苦参注射液 质量评价 |
| DOI：10.13748/j.cnki.issn1007-7693.2019.10.004 |
| 分类号:R917.101 |
| 基金项目:国家中药标准化项目（ZYBZH-C-JIN-43）；山西省重点研发计划重点项目（201603D3113011） |
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| Simultaneous Determination of Seven Constituents in Compound Kushen Injection with Quantitative Analysis of Multi-components by Single-marker |
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NIU Tianzeng1, CHEN Shilin2, WANG Hongfang1, ZHAO Jianbin1, HAI Lina3, QIN Wenjie3
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1.Shanxi Zhendong Pharmaceutical Co., Ltd., Changzhi 047100, China;2.Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China;3.Beijing Zhendong Guangming Pharmaceutical Research Institute Co., Ltd., Beijing 100085, China
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| Abstract: |
| 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. |
| Key words: QAMS relative correlation factor Compound Kushen Injection quality evaluation |
