基于HPLC-QAMS法的解毒通淋丸中10种成分含量测定研究  

Content determination of 10 components in Jiedutonglin Pills based on HPLC-QAMS method

作　　者：张琳[1] 刘光耀 周庆 ZHANG Lin;LIU Guangyao;ZHOU Qing(School of Medical Nursing,Jiyuan Vocational and Technical College,Jiyuan 459000,China;Jiyuan Food and Drug Inspection Institute,Jiyuan 459000,China)

机构地区：[1]济源职业技术学院医学护理学院,河南济源459000 [2]济源市食品药品检验检测中心,河南济源459000

出　　处：《沈阳药科大学学报》2023年第7期872-881,共10页Journal of Shenyang Pharmaceutical University

基　　金：2021年河南省高等学校重点科研项目(21B520010);2019年济源市科技攻关项目(19022019)。

摘　　要：目的建立解毒通淋丸中重楼皂苷Ⅶ、重楼皂苷Ⅵ、重楼皂苷Ⅰ、4′-去甲基鬼臼毒素、鬼臼毒素、泽泻醇F、泽泻醇A、24-乙酰泽泻醇A、23-乙酰泽泻醇B和11-去氧泽泻醇B高效液相色谱-一标多测(high performance liquid chromatography-quantitative analysis of multicomponents by single marker,HPLC-QAMS)含量测定方法。方法采用高效液相色谱法,以鬼臼毒素为内参物,运用外标法与一标多测法检测解毒通淋丸中10种成分的含量,并对比两种方法检测结果的差异性,验证一标多测法在解毒通淋丸质量控制研究中的可行性。结果重楼皂苷Ⅶ、重楼皂苷Ⅵ、重楼皂苷Ⅰ、4′-去甲基鬼臼毒素、鬼臼毒素、泽泻醇F、泽泻醇A、24-乙酰泽泻醇A、23-乙酰泽泻醇B和11-去氧泽泻醇B在各自范围内线性关系良好(r>0.999);平均加样回收率96.9%~100.1%(RSD小于2.0%);两种方法所测结果无差异(P>0.05)。结论采用HPLC-QAMS法对解毒通淋丸中10种成分进行定量评价分析的方法是可行的。Objective To establish the HPLC-QAMS method for content determination of chonglou saponin VII,chonglou saponin VI,chonglou saponin I,4'-demethylpodophyllotoxin,podophyllotoxin,alisol F,alisol A,24-acetate alisol A,23-acetate alisol B and 11-deoxyalisol B in Jiedutonglin Pills.Methods The high performance liquid chromatography was used to detect the contents of 10 components in three batches of Jiedutonglin Pills with podophyllotoxin as the internal reference,and the two methods(external standard method and QAMS)were used and compared.The difference of the results verified the feasibility of the QAMS in the quality control study of Jiedutonglin Pills.Results Chonglou saponin VII,chonglou saponin VI,chonglou saponin I,4'-demethylpodophyllotoxin,podophyllotoxin,alisol F,alisol A,24-acetate alisol A,23-acetate alisol B and 11-deoxyalisol B had good linear relationships within their respective ranges(r>0.999).The average recoveries were 96.9%-100.1%(RSD<2.0%).There was no significant difference between HPLC-QAMS and external standard method(ESM)(P>0.05).Conclusion It is feasible to quantitatively evaluate and analyze 10 components in Jiedutonglin Pills by HPLC-QAMS.

关 键 词：解毒通淋丸 多指标成分 高效液相一标多测法 相对校正因子 含量测定 

分 类 号：R917[医药卫生—药物分析学]