高效液相法快速检测降血脂类中成药中非法添加化学成分  

High performance liquid chromatography method for rapid detection of cholesterol-lowering type of proprietary Chinese medicine illegally added chemicals

作　　者：汤珺 龙玉琼 

机构地区：[1]江西省吉安市食品药品检验检测中心生测室,江西吉安343000 [2]江西省吉安市食品药品检验检测中心化学室,江西吉安343000

出　　处：《中国当代医药》2018年第3期4-6,共3页China Modern Medicine

基　　金：江西省吉安市指导性科技计划项目(吉市科计字[2017]5号)

摘　　要：目的建立快速筛查降血脂类中成药中非法添加普伐他汀钠、阿托伐他汀钙、洛伐他汀、辛伐他汀的分析方法。方法采用十八烷基硅烷键合硅胶柱(Anglient ZORBAX SB-C18,5μm,4.6 mm×150 mm),甲醇0.03 mol/L、磷酸二氢钾(磷酸调p H至3.5)(75∶25)为流动相,流速1.0 ml/min,柱温30℃,检测波长238 nm。结果普伐他汀钠的线性方程为Y=2933.12927X+153.32226(r=0.99971),阿托伐他汀钙的线性方程为Y=2382.54405X-38.16470(r=0.99998),洛伐他汀的的线性方程为Y=2166.75981X+84.99321(r=0.99993),辛伐他汀的线性方程为Y=1784.69863X+147.95365(r=0.99981),峰面积呈良好的线性关系;普伐他汀钠、阿托伐他汀钙、洛伐他汀、辛伐他汀平均回收率(n=6)分别为103.3%(RSD=0.9%)、108.3%(RSD=0.7%)、99.6%(RSD=0.6%)、95.6%(RSD=0.7%)。结论经方法学验证,此方法快速、简便,可以作为分析降血脂类中成药中非法添加的快速有效筛查方法。Objective To establish a quick,sensitive method for analysis of Prefvastatin Sodium,Atorvastatin Calcium,Lovastatin and Simvastatin illegally added into cholesterol-lowering type of proprietary Chinese medicine.Methods Anglient ZORBAX SB-C18 （5 μm,4.6 mm×150 mm） column was used,mobile phase consisted of methanol and 0.03 mol/L phosphate （PH to 3.5） （25：75）with flow rate 1.0 ml/min and column temperature at 30℃.The detection wavelength was set at 238 nm.Results The linear equation of Prefvastatin Sodium was Y=2933.12927X＋153.32226 （r=0.99971）,the linear equation of Atorvastatin Calcium was Y=2382.54405X-38.16470 （r=0.99998）,the linear equation of Lovastatin was Y= 2166.75981X＋84.99321（r=0.99993）,the linear equation of Simvastatin was Y=1784.69863X＋147.95365（r=0.99981）.The average recoveries （n=6） of Prefvastatin Sodium,Atorvastatin Calcium,Lovastatin and Simvastatin were 103.3%（RSD= 0.9%）,108.3%（RSD=0.7%）,99.6%（RSD=0.6%）,95.6%（RSD=0.7%）.Conclusion After validation,the method was proved to be quick and simple,which can he used to detect illegal additive in cholesterol-lowering type of proprietary Chinese medicine.

关 键 词：高效液相法 降血脂类中成药 非法添加 化学成分 普伐他汀钠 阿托伐他汀钙 洛伐他汀 辛伐他汀 

分 类 号：R951[医药卫生—药学]