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中国药物评价 ›› 2025, Vol. 42 ›› Issue (2): 107-110.

• 评价技术与方法 • 上一篇    下一篇

HPLC法测定和中降浊调控丸中2种有效成分的含量

  周丽霞1, 王瑞琪2, 杨娜1, 刘闪闪3, 张峰3, 李清芳3   

  1. 1.开封市中医院, 河南 开封 475000; 

    2.中国中医科学院, 北京 100700;

    3.开封市食品药品质量安全中心, 河南 开封 475000
  • 收稿日期:2024-12-05 修回日期:2025-02-26 出版日期:2025-04-28 发布日期:2025-04-28
  • 基金资助:
    国家中医药管理局中医药科学研究专项课题(GZY-KJS-2021-018);河南省中医药科学研究专项课题(20230317)

Determination of the Contents of Two Effective Components in Hezhong Jiangzhuo Control Pills by HPLC

  1. 1.Traditional Chinese Medicine Hospital of Kaifeng, Henan Kaifeng 475000,China;
    2.China Academy of Chinese Medical Sciences, Beijing 100700,China;
    3.Kaifeng Center for Food and Drug Quality and Safety, Henan Kaifeng 475000,China
  • Received:2024-12-05 Revised:2025-02-26 Online:2025-04-28 Published:2025-04-28

摘要: 目的:构建一种可同步测定和中降浊调控丸中2种有效成分含量的高效液相色谱(HPLC)分析方法,为其质量控制提供参考。方法: 采用ACES C18 色谱柱(250 mm×4.6 mm,5 μm);乙腈-水为流动相展开梯度洗脱;流速为1.0 mL·min-1;柱温为35 ℃;检测波长为283,340 nm双波长检测;进样量为5 μL。结果:和中降浊调控丸中苍术素和橙皮苷分别在0.021 4~0.267 2 μg,0.076 8~0.959 7 μg范围内与峰面积呈现出较好的线性关系(r2≥0.999 9)。精密度、稳定性、重复性实验结果的RSD值均小于2.0%。苍术素和橙皮苷的平均回收率分别为99.64%,101.7%(n=6)。3个不同包装的样品测得苍术素和橙皮苷的含量分别为0.21 mg·g-1和1.27 mg·g-1;0.22 mg·g-1和1.19 mg·g-1;0.22 mg·g-1和1.23 mg·g-1。结论: 该方法操作相对简易,灵敏度颇高,结果稳定可靠,可应用于和中降浊调控丸中苍术素和橙皮苷的质量控制。

关键词: font-size:medium, ">和中降浊调控丸;橙皮苷;苍术素;含量测定

Abstract: Objective: To develop a high-performance liquid chromatography(HPLC) analytical approach enabling the simultaneous determination of the contents of two active ingredients in Hezhong Jiangzhuo control pills, thus providing a reference for its quality control. Methods:An ACES C18 chromatographic column(250 mm×4.6 mm, 5 μm) was employed. The mobile phase consisted of acetonitrile and water for gradient elution. The flow rate was set at 1.0 mL·min-1, and the column temperature was maintained at 35 ℃. Dual-wavelength detection was performed at 283 nm and 340 nm, with an injection volume of 5 μL. Results: For atractylodin and hesperidin in Hezhong Jiangzhuo control pills, excellent linear relationships between their contents and peak areas were observed within the ranges of 0.0214 μg to 0.2672 μg and 0.0768 μg to 0.9597 μg respectively(r2 ≥0.999 9). The relative standard deviation(RSD) values obtained from the precision, stability, and repeatability tests were all less than 2.0%. The average recoveries of atractylodin and hesperidin were 99.64% and 101.7% respectively(n=6). In samples from three different packaging batches, the measured contents of atractylodin and hesperidin were 0.21 mg·g-1 and 1.27 mg·g-1, 0.22 mg·g-1 and 1.19 mg·g-1, as well as 0.22 mg·g-1 and 1.23 mg·g-1 respectively. Conclusion:This method is relatively straightforward to operate and exhibits high sensitivity. The results are stable and reliable, making it suitable for the quality control of atractylodin and hesperidin in Hezhong Jiangzhuo control pills.
 

Key words: font-size:medium, ">Hezhong jiangzhuo control pills; Hesperidin; Atractylotin; Content determination

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