蛤蚧定喘丸中赭曲霉毒素A的暴露量及其最大限值评估
Assessment of ochratoxin A exposure in Gejie Dingchuan Pills and evaluation of its maximum limit levels
黄晓燕 1宋家鸿 1吴越 1吴剑虹 2华小懿1
作者信息
- 1. 无锡市药品安全检验检测中心,无锡 214000
- 2. 江南大学附属精神卫生中心,无锡 214000
- 折叠
摘要
目的 评估蛤蚧定喘丸中赭曲霉毒素A(OTA)的污染情况.方法 收集 7 家药品生产企业共 86 批蛤蚧定喘丸样品,采用超高效液相色谱-质谱串联法检测OTA含量.结果 OTA在浓度 0.1～10 ng/mL范围内线性关系良好.该方法的检出限为0.2 μg/kg,定量限为1 μg/kg.共检出OTA污染样品72批,抽样检出率为84%,检出不合格样品 10 批,抽样不合格率为 12%.实际样品检测结果表明,蛤蚧定喘丸中OTA检出率较高,污染情况严重,提示了检测和确定中成药OTA最高限量的紧迫性.结论 本研究评估了蛤蚧定喘丸中OTA的污染程度,为今后研究中成药中OTA最大限量的研究提供了科学依据.
Abstract
Objective Evaluation of ochratoxin A(OTA)contamination in Gejie Dingchuan Pills.Methods Eighty-six samples from seven pharmaceutical manufacturers were analyzed for OTA content using ultra-high-performance liquid chromatography-tandem mass spectrometry.Results The method displayed excellent linearity within the range of concentrations 0.1～10 ng/mL.The limits of detection and quantification were 0.2 μg/kg and 1 μg/kg,respectively.Seventy-two samples were detected to be contaminated with OTA,resulting in an 84%positive rate.Furthermore,ten samples failed to meet the required standards,reflecting a failure rate of 12%.The actual sample test results showed that the OTA detection rate of Gejie Dingchuan pills was high and the pollution was serious,which suggested the urgency of detecting and determining the maximum OTA limit of proprietary Chinese medicine.Conclusion This study assesses the extent of OTA contamination in Gejie Dingchuan pills,offering a scientific basis for future investigations of OTA maximum limits in Chinese proprietary medicines.
关键词
赭曲霉毒素A/蛤蚧定喘丸/最高限量/中成药Key words
ochratoxin A(OTA)/Gejie Dingchuan Pills/maximum limit/Chinese proprietary medicine引用本文复制引用
出版年
2024
NETL
NSTL
万方数据