目的 建立以对照药材为基准物质定性和不完全依赖对照品定量的当归Angelica sinensis药材“质-量”双标控制方法。方法 采用HPLC技术建立当归对照药材的特征图谱，将其与供试药材图谱进行比对来辨别药材的真伪，即“质”；采用内标物质对特征峰化学成分进行相对定量来区分药材的优劣，即“量”。结果 建立的当归药材“质-量”分析方法符合方法学考察要求，各供试药材与对照药材的相似度均大于0.98；规定了当归药材特征峰化学成分相对含量下限。结论 该方法不依赖多种对照品，能清晰、快速地判断药材的真伪优劣，弥补目前当归药材质量控制的不足，完善中药材质量控制体系，降低中药材（饮片）检测成本，减轻中药企业经济负担，以期推动中医药事业可持续发展。

Objective To establish a "quality-quantity" double standard control method for Angelica sinensis, which is qualitative based on the reference traditional Chinese medicinal materials (TCMM) as standard substances and quantitative without relying on multiple reference substances. Methods HPLC technology was used to establish the characteristic chromatogram of the TCMM of A. sinensis, which was compared with the chromatogram of the tested TCMM to identify the authenticity of the medicinal materials, that is, "quality". The internal standard substance was used to relatively quantify the chemical composition of characteristic peaks to distinguish the quality of medicinal materials, that is, "quantity". Results The established "quality-quantity" analysis method of A. sinensis met the requirements of methodology investigation, and the similarity between the tested TCMM and the reference TCMM was greater than 0.98. The lower limit of relative content of chemical components of characteristic peaks of A. sinensis was defined. Conclusion This method can judge the authenticity of medicinal materials clearly and quickly without many reference substances, make up for the shortage of quality control of A. sinensis at present, improve the quality control system of TCMM, reduce the testing cost of TCMM (decoction pieces), reduce the economic burden of traditional Chinese medicine enterprises, and promote the sustainable development of traditional Chinese medicine.

R286

辽宁省教育厅创新团队项目（LT2017015）