基于“质-量”双标的五味子质量分析方法研究

Research on quality analysis method of Schisandrae Chinensis Fructus based on“quality-quantity”double standard

目的建立以对照药材为基准物质的定性和不依赖多种对照品定量的五味子Schisandrae Chinensis Fructus药材“质-量”双标控制方法。方法采用HPLC技术建立五味子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“五味子甲素”作为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”。结果建立的五味子药材“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0.97;规定了五味子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,弥补目前五味子药材质量控制的不足,且操作简单,结果稳定、可靠。不仅完善中药材质量控制体系,还能减轻中药企业经济负担,为推动中医药事业可持续发展做出贡献。

Objective To establish a“quality-quantity”double standard control method for Wuweizi(Schisandrae Chinensis Fructus),which is qualitative based on the reference traditional Chinese medicinal materials(TCMM)as standard substances and quantitative without relying on a variety of reference substances.Methods The characteristic spectrum of the reference TCMM of Schisandrae Chinensis Fructus was established by HPLC technology,and it was compared with the spectrum of the test TCMM to identify the authenticity of the medicinal material,that is,“quality”;“Schisandrin A”was used as the internal standard substance to relatively quantify the chemical composition of the characteristic peaks to distinguish the quality of medicinal materials,that is,“quantity”.Results The established“quality-quantity”analysis method of Schisandrae Chinensis Fructus met the requirements of the methodological investigation,and the similarity between the tested TCMM and the reference TCMM was greater than 0.97;the lower limit of the relative content of the chemical components of the characteristic peaks of Schisandrae Chinensis Fructus was specified.Conclusion The method can judge the authenticity of medicinal materials clearly and quickly without many reference substances,and make up for the lack of quality control of Schisandrae Chinensis Fructus.The operation is simple,and the results are stable and reliable.It will not only improve the quality control system of TCMM,but also reduce the economic burden of traditional Chinese medicine enterprises and contribute to the sustainable development of traditional Chinese medicine.