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中国医药导刊 ›› 2025, Vol. 27 ›› Issue (6): 629-633.

• 检验检测 • 上一篇    下一篇

壮腰健身丸多指标成分含量测定研究

杨洁1, 蔡靖波2, 万星2, 任琦2, 付辉政2, 潘威3*   

  1. 1.江西省药品检查员中心,江西 南昌 330001;
    2.江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,
    江西省药品与医疗器械质量工程技术研究中心,江西 南昌 330029;
    3.国家药品监督管理局信息中心,北京 100044
  • 收稿日期:2025-03-18 修回日期:2025-04-11 接受日期:2025-05-08 出版日期:2025-06-28 发布日期:2025-08-06
  • 基金资助:
    江西省药品监督管理局科研项目(2024JS19);江西省食品药品监督管理局科研项目(2017YX09);国家药典委员会2016年国家药品标准制修订研究课题(45)

Determination of Multi-Index Components in Zhuangyao Jianshen Pills

YANG Jie1, CAI Jinbo2, WAN Xing2, REN Qi2, FU Huizheng2, PAN Wei3*   

  1. 1.Jiangxi Drug Inspection Center Jiangxi Nanchang 330001, China
    2.Jiangxi Institute for Drug Control NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine
    Jiangxi Province Engineering Research Center of Drug and Medical Device Quality Jiangxi Nanchang 330029, China
    3.Center for Information of NMPA Beijing 100044, China
  • Received:2025-03-18 Revised:2025-04-11 Accepted:2025-05-08 Online:2025-06-28 Published:2025-08-06
  • Supported by:

摘要:

目的:建立超高效液相色谱法测定壮腰健身丸中红景天苷、2354’-四羟基二苯乙烯-2-O-β-D-葡萄糖苷、特女贞苷和大黄素等多指标成分的含量。方法:采用Waters Acquity UPLCTM T3色谱柱(1.8 μm100×2.1 mm);以甲醇(A)-0.1%甲酸溶液(B)为流动相,梯度洗脱;流速为0.2 mL·min-1;检测波长为224254288320 nm多波长切换。结果:红景天苷、2354’-四羟基二苯乙烯-2-O-β-D-葡萄糖苷、特女贞苷和大黄素的进样量分别在0.762 030.48 μg·mL-1r=0.999 9)、0.611 024.46 μg·mL-1r=1.000 0)、3.001120.0 μg·mL-1r=0.999 9)、0.338 013.50 μg·mL-1r=0.999 9)范围内与峰面积呈良好线性关系;平均加样回收率分别为96.6%96.6%96.2%100.4%RSD均小于2.0%n=6)。结论:建立方法实现了对壮腰健身丸中多指标成分含量的同步测定,该方法专属性强、重复性好、准确度高,为保障药品质量、提升用药安全提供了可靠的技术支持。


关键词: 壮腰健身丸, 超高效液相色谱, 多波长切换法, 多指标含量测定

Abstract:

Objective: To establish an ultra-high performance liquid chromatographyUPLC method for the determination of multiple index components such as salidroside 2354'-tetrahydroxystilbene-2-O-β-D-glucoside triligustrine and emodin in Zhuangyao Jianshen Pills.Methods: Waters Acquity UPLCTM Tss T3 column 1.8 μm100 × 2.1 mm was used. MethanolA)-0.1% formic acid solutionB was used as mobile phasegradient elution. The flow rate was 0.2 mL·min-1. The detection wavelength was 224 nm 254 nm 288 nm and 320 nm.Results: There were good linearity in the ranges of 0.762 030.48 μg·mL-1r=0.999 9for salidroside 0.611 024.46 μg·mL-1r=1.000 0for 2354'-tetrahydroxystilbene-2-O-β-D-glucoside 3.001120.0 μg·mL-1r=0.999 9for specnuezhenide and 0.338 013.50 μg·mL-1r=0.999 9 for emodin .The average recoveries were 96.6% 96.6% 96.2% 100.4% and the RSDs were all less than 2.0% n=6.Conclusion: The established method realizes the simultaneou determination of multiple-index components in Zhuangyao Jianshen Pills. The method has strong specificity good repeatability and high accuracy and which provides reliable technical support for ensuring drug quality and improving medication safety.


Key words: Zhuangyao Jianshen pills , Ultra performance liquid chromatographyUPLC); , Multi-wavelength switching method , Multi-index content determination

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