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德吉, 兰钧, 巴桑央宗, 等. 藏药六味能消丸质量标准的建立与优化[J]. koko体育app 学报（医学版）, 2024, 55(2): 425-432. DOI:
引用本文: 德吉, 兰钧, 巴桑央宗, 等. 藏药六味能消丸质量标准的建立与优化[J]. koko体育app 学报（医学版）, 2024, 55(2): 425-432. DOI:
DEJI, LAN Jun, BASANGYANGZONG, et al. Establishment and Optimization of Quality Standards for the Traditional Tibetan Medicine Preparation of Liuwei Nengxiao Pills[J]. Journal of Sichuan University (Medical Sciences), 2024, 55(2): 425-432. DOI:
Citation: DEJI, LAN Jun, BASANGYANGZONG, et al. Establishment and Optimization of Quality Standards for the Traditional Tibetan Medicine Preparation of Liuwei Nengxiao Pills[J]. Journal of Sichuan University (Medic🌊al Sciences), 2024, 55(2): 425-432. DOI:

藏药六味能消丸质量标准的建立与优化

Establishment and Optimization of Quality Standards for the Traditional Tibetan Medicine Preparation of Liuwei Nengxiao Pills

  • 摘要:
    目的  建立六味能消丸的质量标准，对其质量控制方法进行优化，为六味能消丸的质量控制提供参考。
    方法  采用薄层色谱法对不同批号的六味能消丸中的诃子、干姜和藏木香进行鉴别。再用高效液相色谱法（high performance liquid chromatography, HPLC）对制剂中的大黄酚进行含量测定。并通过一系列方法学验证，包括线性关系考察、精密度考察、稳定性考察、重现性考察和加样回收实验来证明结果的可靠性。
    结果  薄层色谱鉴别方法简便，专属性强，斑点清晰，分离效果好，且阴性对照无干扰。HPLC法准确度高，方法学验证结果显示，大黄酚在0.06～0.80 μg范围内与峰面积呈现良好线性关系（r2=1.0），精密度良好（相对标准偏差低于2.0%），稳定性和重现性良好（相对标准偏差均低于1.0%），平均加样回收率为100.8%。
    结论  采用薄层色谱法及HPLC对药物进行质量检测，方法简便、准确度高、重现性好，建立的六味能消丸质量标准科学合理，稳定可行，可为六味能消丸的质量控制提供参考。
     
    Abstract:
    Objective To establish quality standards for Liuwei Nengxiao pills, to optimize the quality control method, and to provide references for the quality control of Liuwei Nengxiao pills.
    Methods Chebula, dried ginger, and Tibetan liqueur root in Liuwei Nengxiao pills of different batch numbers were analyzed by thin layer chromatography (TLC). Then, the content of chrysophanol in the preparation was determined by high performance liquid chromatography (HPLC). Furthermore, a series of methodological validation, including the investigation of the linear relationship, precision, stability, and reproducibility and sample recovery test, were performed to verify the reliability of the results.
    Results The TLC identification method was easy to perform and demonstrated high specificity, clear spots, and good separation effect. In addition, the negative controls showed no interference. The HPLC method showed high accuracy. The results of methodological validation showed that the peak area of chrysophanol had a good linear relationship (r2=1.0) in the range of 0.06-0.80 μg, presenting good precision (with the relative standard deviation being lower than 2.0%), good stability and reproducibility (with the relative standard deviation being lower than 1.0%), and an average recovery rate of 100.8%.
    Conclusion TLC and HPLC are easy to perform, showing high accuracy and reproducibility. The quality standards established are scientific, reasonable, stable, and feasible, providing references for the quality control of Liuwei Nengxiao pills.
     
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