舒筋活血片中非法染色剂酸性红73的检测研究  

Research on Detection of Illegally Added Acid Red 73 in Shujin Huoxue Tablets

作　　者：巩长芹 郑振秋 李志娇 孙成考 GONG Chang-qin;ZHENG Zhen-qiu;LI Zhi-jiao;SUN Cheng-kao(Linyi Institute for Food and Drug Control,Linyi 276001,China)

机构地区：[1]临沂市检验检测中心,山东临沂276001

出　　处：《食品与药品》2023年第4期334-337,共4页Food and Drug

基　　金：2020年山东省药品质量风险监测工作专项课题(编号:鲁食药检业[2020]36号)。

摘　　要：目的 筛查确认舒筋活血片中非法添加的染色剂成分酸性红73并建立检测方法。方法 采用高效液相色谱法(HPLC)对舒筋活血片中非法添加的酸性红73进行筛查,并经HPLC-DAD和HPLC-MS/MS确认,最终采用HPLC测定含量。色谱条件:色谱柱为Agilent ZORBAX SB-C_(18)(4.6 mm×250 mm,5μm),流动相为乙腈(A)-0.05 mol/L乙酸铵溶液(B),梯度洗脱,流量为0.8 ml/min,柱温为30℃,进样量为20μl。结果 46批舒筋活血片样品中有4批检出含酸性红73染色剂。酸性红73进样量在0.004712~4.712μg范围内与峰面积有良好的线性关系(r=0.9999),平均回收率为97.91%,RSD为0.81%。结论 本方法简单、方便、准确、可靠,可对舒筋活血片中非法添加的酸性红73进行有效的排查检测。Objective To Screen and confirm illegally added acid red 73 in Shujin Huoxue Tablets,and establish a detection method.Methods An HPLC method was used to screen acid red 73.The positive results were confirmed by HPLC-DAD and HPLC-MS/MS.The chromatographic separation was performed on an Agilent ZORBAX SB-C_(18)(4.6 mm×250 mm,5μm)column,using acetonitrile(A)-0.05 mol/L ammonium acetate(B)as the mobile phase of gradient elution.The flow rate was 0.8 ml/min,the column temperature was 30℃,and the injection volume was 10μl.Results Out of 46 batches of samples of Shujin Huoxue Tablets,4 batches were found to contain acid red 73.The linear relationship between the injection volume and peak area of acid red 73 was good in the range of 0.004712-4.712μg(r=0.9999).The average recovery was 97.91%,with RSD of 0.81%.Conclusion The method is simple,convenient,accurate and reliable,and can be used for effective screening and detection of illegally added acidic red 73 in Shujin Huoxue Tablets.

关 键 词：舒筋活血片 酸性红73 风险监测抽检 HPLC HPLC-MS/MS 

分 类 号：R284.1[医药卫生—中药学]