草乌甲素杂质——滇乌碱的制备与应用OA

(Objective)To provide a method for the preparation of yunaconitine,an impurity of bulleyaconitine A,and explore the feasibility of using yunaconitine as an impurity reference substance.(Methods)The structure was confirmed by nuclear magnetic resonance spectroscopy and mass spectrometry,etc,the purity determination and quality control use HPLC.(Results)The white solid prepared was confirmed by structure confirma-tion and purity determination,and the purity was 99.51%and the yield was 58.1%.Bulleyaconitine A and its impurity yunaconitine has good line-arity in the concentration range of 0.08 to 1.0μg/mL and the relative correction factor is 0.95.(Conclusion)The yunaconitine prepared in this study can be used as a reference substance.In the study of the quality of the raw material and preparation of bulleyaconitine A,yunaconitine can be used as a known impurity for positioning and precise control,which improves the quality of bulleyaconitine A and ensures the safety of patients.