Study on TLC and Multi-index Component Content Determination of Pinggan Yishen Granules (平肝益肾颗粒)

Author：WANG Huihui1,2, WU Lei1,2, WANG Han1,2, ZHANG Siqi1, WANG Qiong1,2, ZHANG Weiting1,2, FANG Zhuyuan1,2

Unit：1.Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing Jiangsu 210029, China; 2.The First Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing Jiangsu 210029, C

Quote：引用：王慧惠，吴磊，王晗，张思奇，王琼，章伟婷，方祝元.平肝益肾颗粒的薄层鉴别及多指标成分含量测定[J].中医药导报,2025,31(1):71-76.

DOI：10.13862/j.cn43-1446/r.2025.01.013

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Abstract：Objective: To establish the quality standard of Pinggan Yishen granules by thin layer identification and multi-index component content determination. Methods: A TLC identification method for Tianma (Gastrodiae rhizoma), Gouteng (Uncariae ramulus cum uncis), Chuanxiong (Chuanxiong rhizoma) and Chuanniuxi (Cyathulae radix) in Pinggan Yishen granules was established. A method for the determination of gastrodin, geniposide, ferulic acid, isorhynchophylline, astragaloside and kaempferol was established. Results: The TLC of Tianma (Gastrodiae rhizoma), Gouteng (Uncariae ramulus cum uncis), Chuanxiong (Chuanxiong rhizoma) and Chuanniuxi (Cyathulae radix) showed the same color spots in the same position as the corresponding control medicinal materials, and the negative control had no interference, with good characteristics. The linear ranges of gastrodin, geniposide, ferulic acid, isorhynchophylline, astragaloside and kaempferol were 16.45-1 053.00 μg/mL (r=0.999 8), 85.08-5 445.00 μg/mL (r=0.999 9), 26.25-1 680.00 μg/mL (r=0.999 8), 21.84-1 398.00 μg/mL (r=0.999 7), 21.16-1 354.00 μg/mL (r=0.999 7) and 17.94-1 148.00 μg/mL (r=0.999 4), respectively. The results of precision test, stability test, repeatability test and sample recovery test all met the methodological requirements. Conclusion: The results show that the thin layer identification method and content determination method established in this study have strong specificity and good reproducibility, and can be used for the quality control of Pinggan Yishen granules.

Key words：Pinggan Yishen granules; TLC; HPLC; content determination; quality standard

摘要：目的：通过薄层鉴别和多指标成分含量测定建立平肝益肾颗粒的质量标准。方法：建立平肝益肾颗粒中天麻、钩藤、川芎及川牛膝的薄层鉴别方法；建立天麻素、栀子苷、阿魏酸、异钩藤碱、沙苑子苷及山柰酚的含量测定方法。结果：天麻、钩藤、川芎及川牛膝的薄层色谱与相应的对照药材在相同位置上显相同颜色的斑点且阴性对照无干扰，具有良好的特征性。天麻素、栀子苷、阿魏酸、异钩藤碱、沙苑子苷及山柰酚分别在16.45~1 053.00 μg/mL（r=0.999 8）、85.08～5 445.00 μg/mL（r=0.999 9）、26.25～1 680.00 μg/mL（r=0.999 8）、21.84～ 1 398.00 μg/mL（r=0.999 7）、21.16～1 354.00 μg/mL（r=0.999 7）及17.94～1 148.00 μg/mL（r=0.999 4）内与峰面积呈良好的线性关系，精密度试验、稳定性试验、重复性试验及加样回收率试验结果均符合方法学要求。结论：本研究建立的薄层鉴别方法和含量测定方法专属性强、重现性好，可用于平肝益肾颗粒的质量控制。

关键词：平肝益肾颗粒；薄层色谱；高效液相色谱；含量测定；质量标准

Release time：2025-11-28

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