目的 研究蒙药阿格希日嘎与中药藜芦在化学成分和毒性方面的差异，为蒙药阿格希日嘎质量标准的制定奠定基础。方法 建立藜芦甾体生物碱类和茋类成分的HPLC指纹图谱，测定不同来源的8批蒙药阿格希日嘎和6批中药藜芦，所得色谱图导入“中药指纹图谱相似度评价系统”，建立蒙药阿格希日嘎和中药藜芦指纹图谱共有模式并进行相似度评价。选取藜芦特征色谱峰，包括甾体生物碱类32个和茋类16个，以各峰面积占总峰面积的百分比为变量，运用SPSS 20.0软件进行聚类分析。采用小鼠急性毒性实验法评价蒙药阿格希日嘎和中药藜芦的毒性。结果 建立了藜芦甾体生物碱类和茋类成分的HPLC指纹图谱测定方法，得到了蒙药阿格希日嘎和中药藜芦指纹图谱共有模式，各样品与其共有模式之间相似度良好。以甾体生物碱类和茋类成分为指标的聚类分析，均将14批药材聚成蒙药阿格希日嘎与中药藜芦2大类。蒙药阿格希日嘎比中药藜芦的急性毒性大，LD₅₀分别为0.503 0和17.934 3 g/kg。结论 蒙药阿格希日嘎与中药藜芦在功效主治、产地、化学成分和毒性方面具有很大差异，应区分入药并制定蒙药阿格希日嘎质量标准。

Objective To evaluate the quality differences between Mongolian medicine and traditional Chinese medicine (TCM) Veratri Nigri Radix et Rhizoma in HPLC fingerprint and acute toxicity, as a fundamental research for quality standazation. Methods HPLC fingerprint methods were used to analyze the steroid alkaloids and stilbenes of Veratri Nigri Radix et Rhizoma from different origins. A total of 14 batches of crude drugs, including eight Mongolian and six TCM samples, were examined, and their common pattern were established by authoritative software “fingerprint similarity evaluation system”. Characteristic peaks in these fingerprints, including 32 steroid alkaloids and 16 stilbenes, were selected to performing cluster analysis, using SPSS 20.0 software with relative peak area as variables. Through the experiments of acute toxicity in mice, their toxicities were examined. Results HPLC fingerprint methods of steroid alkaloids and stilbenes were established for the quality evaluation of Veratri Nigri Radix et Rhizoma, and their common patterns of Mongolian medicines (RMJ, RMZ) and TCMs (RZJ, RZZ) with high similarities between groups were obtained. In clustering analysis, 14 batches of Veratri Nigri Radix et Rhizoma were divided into two categories distinctly, as Mongolian medicine and TCM groups. Mongolian medicine showed stronger toxicity than TCM with the LD₅₀ values as 0.503 0 and 17.934 3 g/kg, respectively. Conclusion The quality of Mongolian medicine and TCM Veratri Nigri Radix et Rhizoma in the aspects of efficacy and idications, producing area, chemical composition and acute toxicity were of significant differences. It is necessary and emergency to distinguish the two crude drugs, and establish quality standard of Mongolian medicine Veratri Nigri Radix et Rhizoma.

《中国药典》2015年版民族药材标准增修订计划（蒙药）项目“蒙药材藜芦质量标准研究”（M55）