摘要
目的:建立顶空-气相色谱法对益肝灵制剂中水飞蓟素原料药进行包括甲醇、乙醇、丙酮、乙酸乙酯、异丙醇、正己烷、异辛烷七种有机溶剂的残留分析。方法:经顶空进样,采用Agilent DB-624(30 m×0.53 mm×3μm)色谱柱,程序升温,使用火焰离子化检测器检测。结果:7种有机溶剂在一定浓度范围内线性关系良好(r均>0.9990),方法精密度、重复性、稳定性良好,平均回收率为96.12%~102.99%,RSD均<5%(n=6)。结论:本方法能较全面、准确的测定益肝灵制剂中水飞蓟素原料药中7种有机溶剂的残留含量,该方法的建立可为其质量控制、临床应用和综合评价提供方法依据。
Objective:A headspace-gas chromatography method was established for the residue analysis in silymarin of Yiganling preparations,including methanol,ethanol,acetone,ethyl acetate,isopropanol,n-hexane and isooctane.Method:After headspace injection,Agilent DB-624 (30 m×0.53 mm×3μm) chromatographic column was used to detect the concentration with temperature programmed.Flame ionization detector was used for detection.Result:The linear relationship of 7 organic solvents in a certain concentration range was good (r > 0.9990).The method had good precision,repeatability and stability.The average recovery was 96.12% ~ 102.99%,and RSD was less than 5% (n=6).Conclusion:This method can comprehensively and accurately detect the residual content of seven organic solvents in silymarin of Yiganling preparation.The establishment of the method can provide a method for quality control,clinical application and comprehensive evaluation.
作者
金丽鑫
苟琰
黄泽玮
JIN Li-xin;GOU Yan;HUANG Ze-wei(Sichuan Instinte for Food and Drug Conrol,Chengdu 611731,Sichuan;School of Pharmaly,Chengdu University of Traditional Chinese Medicine,Chengdu 611373,Sichuan)
出处
《中药与临床》
2019年第5期13-15,43,共4页
Pharmacy and Clinics of Chinese Materia Medica
关键词
水飞蓟素
顶空-气相色谱法
溶剂残留
含量测定
Silymarin
headspacc-gas chromatography
solvent residue
content determination
