基于质量标志物的三七粉质量标准提升研究

Improvement Researches on Quality Standard of Radix Notoginseng Powder Based on Quality Marker

目的基于三七粉质量标志物的研究结果,完善三七粉质量标准,为其质量标准的修订提供科学依据。方法利用高效液相色谱技术,结合“一测多评”等分析方法,对三七粉质量标志物进行含量测定,对不同厂家三七粉及不同商品规格原料药材进行质量标志物差异分析。建立指纹图谱,采用新的相似度计算模型-等同系数法和模式识别对三七粉及原料药材进行质量一致性评价。结果不同厂家三七粉中三七素含量存在差异,收集到的白云山和黄中药三七粉中三七素含量均高于其余厂家,提示三七素可能为白云山和黄中药三七粉的优势指标。原料药材中三七素和皂苷含量与头数不具相关性,但与季节、部位具有相关性。皂苷方面表现为冬三七>春三七,芦头>主根>须根>筋条;三七素方面表现为冬三七>春三七,须根>芦头>筋条>主根。应用等同系数法计算指纹图谱相似度实现了不同厂家三七粉的区分,进一步结合化学模式识别实现了不同规格原料药材的区分。结论建立的含量测定及指纹图谱方法稳定可行,专属性强,对于控制三七粉质量具有显著意义。与2020年版《中国药典》相比,该文修订了三七粉含量测定项,增加了HPLC指纹图谱项,可为三七粉的质量标准提升及其原料药材的选择提供科学依据。

Objective To improve the quality standard and supply the scientific basis for Radix Notoginseng Powderbased on the results of the quality marker(Q-Marker) of Radix Notoginseng Powder.Methods High performance liquid chromatography technology, combined with QASM and other analytical methods were used to determine the content of Q-Marker. The difference analysis of Radix Notoginseng Powder of different manufacturers and different commodity norms of raw materials was carried out. The fingerprints were established and a new similarity calculation model-equivalence coefficient method combined with pattern recognition was used to evaluate the quality consistency of the Radix Notoginseng Powder and its raw materials.Result There were differences in the content of dencichine in the Radix Notoginseng Powder from different manufacturers. The content of dencichine in the Radix Notoginseng Powder of Guangzhou Baiyun Mountain and Hutchison Whampoa Co., Ltd. was higher than that of other manufacturers, suggesting that dencichine was the advantage index of it. The content of dencichine and saponins in the raw materials had little relationship with the number, but had correlation with the season and part. The content of saponins showed as Dong Radix Notoginseng>Chun Radix Notoginseng, reed head> tap root> fibrous root> tendon. Dencichine showed Dong Radix Notoginseng>Chun Radix Notoginseng, fibrous root> reed head> tendon> tap root. We applyed the equivalent coefficient method to calculate the similarity of fingerprints to realize the distinction between different manufacturers of Radix Notoginseng Powder, and further combined the pattern recognition to distinguish the raw materials of different norms.Conclusion The established method for content determination and fingerprint is stable, feasible, specific, and has significant meaning for controlling the quality of Radix Notoginseng Powder. Compared with the 2020 edition of the Chinese Pharmacopoeia, this article has revised the content determination items of Radix Notoginseng Powder and added HPLC fingerprint, which can provide a scientific basis for the promotion of quality standards for Radix Notoginseng Powder and the selection of raw materials.