草乌甲素杂质——滇乌碱的制备与应用  

Preparation and Application of Yunaconitine an Impurity of Bulleyaconitine A

作　　者：付彬彬 龚爽 龚云麒 刘军锋 Fu Binbin;Gong Shuang;Gong Yunqi;Liu Junfeng(Kunming Pharmaceutical(Group)Co.,ltd.,Kunming 650021,China)

机构地区：[1]昆药集团股份有限公司,云南昆明650021

出　　处：《云南化工》2024年第5期35-38,共4页Yunnan Chemical Technology

摘　　要：[目的]提供了一种草乌甲素杂质——滇乌碱的制备方法,探究了滇乌碱作为杂质对照品应用的可行性。[方法]采用核磁共振波谱、质谱等进行结构确认,采用高效液相色谱进行纯度测定及质量控制研究。[结果]通过结构确认及纯度测定证实了制备得到的白色固体为滇乌碱,且纯度为99.51%,收率为58.1%。草乌甲素及杂质滇乌碱溶液在0.08μg/mL至1.0μg/mL质量浓度范围内线性良好且相对校正因子为0.95。[结论]制备出的滇乌碱可以作为对照品使用,在草乌甲素原料及制剂质量研究中,可以将滇乌碱当做已知杂质进行定位归属和精确控制,提高了草乌甲素药品质量,保证患者用药安全。(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 confirmation and purity determination,and the purity was 99.51%and the yield was 58.1%.Bulleyaconitine A and its impurity yunaconitine has good linearity 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.

关 键 词：草乌甲素 滇乌碱 制备方法 对照品 质量研究 

分 类 号：R927.2[医药卫生—药学]