基于质量源于设计理念优化抑肝散提取物中生物碱的含量测定方法  

Optimization of the content determination method of alkaloids in Yigansan extract based on the concept of quality derived design

作　　者：吕令蕊 马潇 董振环 韩凌飞[1] 柳文媛[1] LYU Lingrui;MA Xiao;DONG Zhenhuan;HAN Lingfei;LIU Wenyuan(Department of Pharmaceutical Analysis,China Pharmaceutical University,Jinagsu Province,Nanjing211198,China;Gansu Institute for Drug Control,Gansu Province,Lanzhou730070,China)

机构地区：[1]中国药科大学药物分析系,江苏南京211198 [2]甘肃省药品检验研究院,甘肃兰州730070

出　　处：《中国当代医药》2023年第27期4-7,12,共5页China Modern Medicine

基　　金：国家自然科学基金资助项目(81274064);中药材及饮片质量控制重点实验室项目(2022GSMPA-KL06)。

摘　　要：目的运用质量源于设计理念开发抑肝散提取物中生物碱的高效液相色谱分析方法。方法利用响应面设计法和Drylab软件优化抑肝散提取物中生物碱含量测定色谱条件,并通过单因素影响实验验证方法可靠性。结果采用Hanbon Megres C18色谱柱(250 mm×4.6 mm,5μm);以乙腈(A)∶15 mmol/L乙酸铵(B)=45∶55进行等度洗脱,流速为1.0 ml/min,检测波长为245 nm,柱温35℃,钩藤碱和异钩藤碱在1~50μg/ml内的线性关系良好,数据均符合要求。结论基于QbD理念进行药物分析方法的开发和完善,有效提高了实验效率,有利于分析方法的转移。Objective To develop a HPLC analysis method for alkaloids in Yigansan extract using quality derived design concepts.Methods Response surface design method and Drylab software were used to optimize the chromatographic conditions for the determination of alkaloids in extracts of Yigansan,and the reliability of the method was verified by single factor.Results The chromatography was performed on Hanbon Megres C18 column(250 mm×4.6 mm,5μm).Iso-elution was performed with acetonitrile(A)∶15 mmol/L ammonium acetate(B)=45∶55 at a flow rate of 1.0 ml/min,detection wave length of 245 nm,and column temperature of 35℃.The linear relationship between uncinine and isuncinine was good in 1-50μg/ml,and the data met the requirements.Conclusion The development and improvement of drug analysis methods based on QbD concept can effectively improve the experimental efficiency and facilitate the transfer of analysis methods.

关 键 词：质量源于设计 Drylab软件 抑肝散提取物 生物碱 

分 类 号：R284.1[医药卫生—中药学]