首页|液体型医用退热凝胶中非法添加对乙酰氨基酚药物成分的检测与分析

液体型医用退热凝胶中非法添加对乙酰氨基酚药物成分的检测与分析

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目的:利用高效液相色谱-串联质谱法和高效液相色谱法对医用退热凝胶中对乙酰氨基酚进行定性识别及含量测定.方法:建立了医用退热凝胶样品浸提方法,液相色谱方法和液质联用方法参考标准《贴敷类医疗器械中17种化学药物识别及含量测定补充检验方法》的检验方法,采用HPLC-MS/MS法对样品(10批医用退热凝胶)中非法添加的对乙酰氨基酚进行定性鉴别,采用高效液相色谱法进行含量测定.结果:对乙酰氨基酚质量浓度在2.2~110μg/mL(n=5)范围内线性良好,相关系数r=0.999,平均加标回收率为91%~103%(n=6),精密度的RSD值为1.04%(n=6),均符合要求.利用该方法对市售的10批医用退热凝胶进行检测,其中4批医用退热凝胶检出对乙酰氨基酚,检出率为40%.其含量为1~10mg/mL.结论:该方法操作简单,灵敏度准确度高,可用于液体型医用退热凝胶产品非法添加对乙酰氨基酚定性和定量分析,市售的医用退热凝胶中存在非法添加对乙酰氨基酚现象存在,需要加强监管.
Detection and Analysis of Illegal Addition of Paracetamol in Liquid Medical Antipyretic Gel
Objective:The qualitative identification and content determination of paracetamol in medical antipyretic gel were carried out by HPLC tandem mass spectrometry and HPLC.Methods:The reference standard of medical antipyretic gel sample extraction method,liquid chromatography method and LMS method,"Supplementary test method for Identification and content determination of 17 Chemical Drugs in Affixed medical devices",was established.HPLC-MS/MS method was used to qualitatively identify the illegally added paracetamol in samples,and high performance liquid chromatography was used to determine the content.Results:The mass concentration of acetaminophen was in the range of 2.2-110μg/mL(n=5),the correlation coefficient r=0.999,the average recovery rate was 91%-103%(n=6),and the RSD value of precision was 1.04%(n=6),all of which met the requirements.Acetaminophen was detected in 4 of 10 batches of medical antipyretic gels,the detection rate was 40%.Its content was 1-10mg/mL.Conclusion:The method is simple to operate,has high sensitivity and accuracy,and can be used for qualitative and quantitative analysis of illegal addition of paracetamol to liquid medical antipyretic gels.Illegal addition of paracetamol exists in medical antipyretic gels sold on the market,so it is necessary to strengthen supervision.

medical antipyretic gelacetaminophenhigh performance liquid chromatography-mass spectrometryhigh performance liquid chromatography

魏嫣、梅享林、李玲、田荻

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湖北省医疗器械质量监督检验研究院 (湖北 武汉 430075)

医用退热凝胶 对乙酰氨基酚 高效液相色谱-质谱联用法 高效液相色谱法

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(17)