首页|九味肝泰胶囊的化学成分鉴定及10种指标成分含量测定

九味肝泰胶囊的化学成分鉴定及10种指标成分含量测定

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目的 鉴定九味肝泰胶囊的化学成分,同时测定制剂中 10 种指标成分的含量。方法 查阅TCMSP、ChemSpider、中国知网、PubMed等数据库中的相关文献,收集制剂的核心化学成分 181 个,采用Agilent"formula-database generator"软件建立化学成分数据库,采用高效液相色谱-飞行时间质谱联用法鉴定制剂的化学成分;采用超高效液相色谱串联质谱法测定制剂中 10种指标成分的含量。结果 共鉴定出 45种化学成分。姜黄素在 1~50 ng/mL,大黄酚、大黄素、吉马酮、五味子醇甲、五味子甲素在 200~10000 ng/mL,尿囊素、黄芩苷、人参皂苷Rg1、三七皂苷R1 在 1 000~50 000 ng/mL质量浓度范围内与待测成分和内标峰面积比值线性关系良好(r均大于 0。999 0),定量限分别为 0。05,10,0。5,10,0。05,0。05,0。05,0。5,0。5,10 ng/mL,检测限分别为 0。01,1,0。25,1,0。01,0。01,0。01,0。1,0。1,1 ng/mL;精密度、稳定性、重复性试验结果的RSD均小于 5。0%;平均加样回收率为 98。13%~102。64%,RSD为 0。54%~4。10%(n=6)。结论 该方法快速简便,可用于九味肝泰胶囊的化学成分鉴定和指标成分含量测定。
Chemical Component Identification in Jiuwei Gantai Capsules and Content Determination of 10 Indicator Components
Objective To identify the chemical components of Jiuwei Gantai Capsules and determine the contents of 10 indicator components in the preparation.Methods Based on the TCMSP,ChemSpider,CNKI and PubMed databases,181 core chemical components of the preparation were collected,and a chemical component database was established by the Agilent ″formula-database generator″ software.The chemical components of the preparation were identified by the high-performance liquid chromatography time-of-flight tandem mass spectrometry(HPLC-TOF/MS)method,the contents of 10 indicator components in the preparation were determined by the ultra-high-performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS)method.Results A total of 45 chemical components were identified.The linear range of curcumin was 1-50 ng/mL,that of chrysophanol,emodin,germacrone,schisandrin and deoxyschizandrin was 200-10 000 ng/mL,that of allantoin,baicalin,ginsenoside Rg1 and notoginsenoside R1 was 1 000-50 000 ng/mL(r>0.999 0).The limits of quantification of the above 10 components were 0.05,10,0.5,10,0.05,0.05,0.05,0.5,0.5,10 ng/mL respectively,and their limits of detection were 0.01,1,0.25,1,0.01,0.01,0.01,0.1,0.1,1 ng/mL respectively.The RSDs of precision,stability and repeatability tests were all lower than 5.0%.The recovery rates of the above 10 components were in the range of 98.13%to 102.64%,with the RSDs in the range of 0.54%to 4.10%(n=6).Conclusion This method is fast and simple,which can be used for the identification of chemical components and content determination of indicator components in Jiuwei Gantai Capsules.

Jiuwei Gantai Capsulescomponent identificationcontent determinationquality controlHPLC-TOF/MSUPLC-MS/MS

谢雪、朱平、吕磊、凌水花、鲍蕾蕾

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中国人民解放军海军军医大学第三附属医院,上海 200438

九味肝泰胶囊 成分鉴定 含量测定 质量控制 高效液相色谱-飞行时间质谱联用法 超高效液相色谱串联质谱法

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(12)