建立龙泽熊胆胶囊中水防风掺伪的检测方法。方法 以水防风区别于防风的专属性成分 Xanthalin 建立薄层色谱鉴别法（TLC），对样品进行初筛。若供试品溶液色谱中出现水防风特征斑点，则采用 高效液相色谱（HPLC）进行定性检查。色谱条件： SHIMADZU InertSustain® C18 色谱柱（250 mm × 4.6 mm， 5 μm）；以乙腈-水（58∶42）为流动相，等度洗脱；流速：1.0 mL·min-1；柱温：30 ℃；检测波长：324 nm；进 样量：10 μL。若供试品Xanthalin 色谱峰面积大于对照品的峰面积，视为阳性检出，必要时可进一步采用超高 效液相色谱串联三重四级杆质谱法（UPLC-MS/MS）进一步确证。结果 建立的TLC 法、HPLC 法简便、快速， 专属性、重复性、耐用性均符合《中国药典》要求。对市售107 批龙泽熊胆胶囊样品进行检测，19 批次样品 检出Xanthalin，提示该制剂存在水防风掺伪投料生产的风险。结论 该方法可实现水防风掺伪防风的定性鉴 别，有助于完善该品种的质量控制。

To establish analytical methods of Libanotis laticalycina adulterated in Longze Xiongdan Capsules. Methods Utilizing the characteristic component of Libanotis laticalycina （Xanthalin） to develop TLC method， the initial screening of the sample was performed. If the characteristic spot of Xanthalin was found， the analysis was carried out by HPLC. HPLC method was performed on SHIMADZU InertSustain® C18 （250 mm× 4.6 mm，5 μm） column with acetonitrile-water （58∶42） as mobile phase by isocratic elution at a flow rate of 1.0 mL·min-1. The column temperature was 30 ℃， the detection wavelength was set at 324 nm， and the sample injection volume was 10 μL. When the chromatographic peak area of Xanthalin in test samples was greater than that in reference samples，it suggested that Libanotis laticalycina was used to adulterate in Longze Xiongdan Capsules. If necessary，ultra-performance liquid chromatography-tandem mass spectrometry （UPLC-MS/MS） could be used for further confirmation. Results TLC and HPLC methods are simple and fast. The specificity， repeatability and durability all met the requirements of “Chinese Pharmacopoeia”. The result showed that Xanthalin in 19 batches of samples was detected in 107 batches of Longze Xiongdan Capsules， which indicated that there was a risk of the adulteration of Libanotis laticalycina in production of Longze Xiongdan Capsules. Conclusion The method could be applied to inspect Libanotis laticalycina adulterated in Longze Xiongdan Capsules qualitatively，which could improve the quality control of this preparation

R284.1

广东省药品监督管理局科技创新项目（2023YDZ03）；广东省医学科研基金项目（B2023258）。