HPLC测定右归胶囊中双酯型生物碱的限量  

Determination of diester alkaloids limit in Yougui capsules by HPLC

作　　者：肖草茂 李春红[2] 李后如 李玉云 马员宇 XIAO Caomao;LI Chunhong;LI Houru;LI Yuyun;MA Yuanyu(Jiangxi Medical Device Testing Center,Nanchang,Jiangxi,330029 P.R.China;the Fourth Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,330021 P.R.China;Jiangxi Yintao Pharmaceutical Co.,Ltd.,Fuzhou,Jiangxi,344100 P.R.China)

机构地区：[1]江西省医疗器械检测中心,江西南昌300029 [2]南昌大学第四附属医院,江西南昌330021 [3]江西银涛药业有限公司,江西抚州344100

出　　处：《华西药学杂志》2023年第5期542-544,共3页West China Journal of Pharmaceutical Sciences

基　　金：江西省药品监督管理局科研项目(2021KY22)。

摘　　要：目的 测定右归胶囊中双酯型生物碱的限量。方法 采用HPLC法测定右归胶囊附子中双酯型生物碱(新乌头碱、次乌头碱、乌头碱)的限量。结果 新乌头碱、次乌头碱、乌头碱色谱峰的分离度与拖尾因子较好,三者的线性关系均良好(r2≥0.9999),精密度、稳定性、重复性试验的RSD均小于2%,回收率均符合2020年版《中国药典》中的要求。结论 所用方法的专属性强、操作简便,可用于检查右归胶囊中双酯型生物碱的限量,更全面地控制其质量。OBJECTIVE To determine the limit diester alkaloids in Yougui capsules(YGC).METHODS The limit test of mesaconitine,hypaconitine and aconitine in YGC aconite were studied by HPLC.RESULTS The separation degree of mesaconitine,hypaconitine and aconitine is good,and three substances had good linear relationship(r 2≥0.9999).The RSDs of precision,stability and repeatability tests were less than 2%.The above conditions met the requirements of Chinese Pharmacopoeia 2020 edition.CONCLUSION The method is specific and simple,and could be used for the limit inspection of diester alkaloids in YGC,which can control the quality and safety for more comprehensively.

关 键 词：右归胶囊 高效液相色谱法 限量 附子 生物碱 乌头碱 次乌头碱 新乌头碱 

分 类 号：R917[医药卫生—药物分析学]