摘要
目的:建立感冒退烧片中非法添加感冒类化学药品的检查方法。方法:采用Agilent XDB-C_(18)色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.2%磷酸(梯度洗脱)为流动相,检测波长:210 nm(全波长扫描范围为190~400 nm),柱温为30℃,流速为1.0 m L/min,进样量为5μL。通过比对供试品与对照品HPLC色谱及光谱,对感冒退烧片中是否非法添加对乙酰氨基酚、双氯芬酸钠、氨基比林、贝诺酯、咖啡因、醋酸泼尼松进行检测,并利用超高效液相色谱-质谱联用技术对阳性检出样品进行确认。结果:本方法可用于感冒退烧片中非法添加对乙酰氨基酚、双氯芬酸钠、氨基比林、贝诺酯、咖啡因、醋酸泼尼松6种成分的检测,检测限分别为0.207 mg/g、0.159 mg/g、0.305 mg/g、0.170 mg/g、0.289 mg/g。结论:该法可对感冒退烧片中非法添加上述化学药品进行筛查,以期为药品监管提供可靠的检测方法。
Objective:To establish an inspection method for illegal addition of cold chemicals in Ga nmaotuishao tablets.Methods:Agilent XDB-C_(18) column(250 mm×4.6 mm,5μm)was used,acetonitrile-0.2%phosphoric acid(gradient elution)was used as mobile phase,detection wavelength was 210 nm(full wavelength scanning range was 190~400 nm),the column temperature was 30℃,the flow rate was 1.0mL/min,and the injection volume was 5μL.By comparing the HPLC chromatogram and spectrum of the test sample with that of the reference sample,it was detected whether acetaminophen,diclofenac sodium,aminopyrine,Benoite,caffeine and prednisone acetate were illegally added in Ga nmaotuishao tablets,and the positive samples were confirmed by ultra performance liquid chromatography-mass spectrometry.Results:The method can be used for the detection of acetaminophen,diclofenac sodium,aminopyrine,Benoite,caffeine and prednisone acetate illegally added in Ga nmaotuishao tablets,with detection limits of 0.207 mg/g,0.159 mg/g,0.305 mg/g,0.170 mg/g and 0.289 mg/g,respectively.Conclusion:This method can screen the above-mentioned chemicals illegally added in Ga nmaotuishao tablets in order to provide a reliable detection method for drug supervision.
作者
姜莲
陈雯
王影超
刘兴鹏
舒柯
Jiang Lian;Chen Wen;Wang Yingchao;Liu Xingpeng;Shu Ke(Guizhou Food and Drug Inspection Institute,Guiyang 550081,China;Key Laboratory of Quality Control and Evaluation for Traditional Chinese Medicine and Ethnic Medicine,Guizhou Provincial Administration for Market Regulation,Guiyang 550081,China)
出处
《广东化工》
2025年第20期112-115,111,共5页
Guangdong Chemical Industry
基金
国家药典委员会2024年度国家药品标准制修订研究课题(2024Z015)。
