目的 建立莨菪浸膏片的HPLC特征指纹图谱，并对其中阿托品、山莨菪碱、东莨菪碱、樟柳碱4种莨菪烷类生物碱进行定量分析。方法 采用GL Sciences Inc C₁₈（250 mm×4.6 mm，5 μm）色谱柱，以甲醇-0.05%磷酸水溶液为流动相，梯度洗脱；检测波长218 nm；体积流量1.0 mL/min；柱温30℃，利用"中药色谱指纹图谱相似度评价系统软件（2004A版）"和SPSS 19.0建立莨菪浸膏片指纹图谱，并进行相似度评价及定量分析。结果 标记共有峰14个，S1~S4以及S11与对照指纹图谱的相似度大于0.98，其他均大于0.995，表明12批莨菪浸膏片相似度良好。聚类分析结果显示，S1~S6聚为一类，其余样品聚为一类。定量分析结果显示不同批次的莨菪浸膏片中均含有阿托品、东莨菪碱、山莨菪碱，但含量存在一定差异。结论 该方法较好地反映了莨菪浸膏片中的生物碱组成信息，且操作简单，重复性好，为莨菪浸膏片的质量评价提供了更加全面、科学的数据。

Objective To establish a fingerprint of Hyoscyamus Extract Tablets (HET) by high performance liquid chromatography and determine the content of atropine, anisodamine, scopolamine, and anisodine. Methods The separation was performed on a GL Sciences Inc C₁₈ (250 mm×4.6 mm, 5 μm) column with gradient elution of methanol and 0.05% phosphoric acid solution. The detection wavelength was set at 218 nm, the flow rate was 1.0 mL/min, and the column temperature was 30℃. Similarity evaluation system for chromatographic fingerprint of TCM was used for establishing the reference fingerprint and similarity evaluation, and clustering analysis was carried out by SPSS 19.0. Results There were 14 marked common peaks, and the similarity of S1-S4, S11 and the control fingerprint was over 0.98, others were above 0.995. It was shown that these 12 batches of samples were of good similarity. Cluster analysis results showed that the S1-S6 were grouped into one class, and the remaining samples were grouped into one class. The results of assay showed that alkaloids in different batches of HET varied a lot in contents but kept consistent in compositions. Conclusion The method could well display the chemical information of HET. It has simple operation and good repeatability, which provides more comprehensive and scientific data for quality evaluation of HET.

国家十二五"重大新药创制"专项（2015ZX0903001）；陕西省社会发展科技攻关项目（2016SF-058）