文章摘要
王冰,曹春琪,冯亚楠,等.ICP-MS结合化学计量学的血塞通注射液中 40种无机元素分析及风险评估[J].安徽医药,2022,26(10):1925-1929.
ICP-MS结合化学计量学的血塞通注射液中 40种无机元素分析及风险评估
ICP-MS combined with chemometrics analysis of 40 inorganic elements in Xuesaitong injection and risk Assessment
  
DOI:10.3969/j.issn.1009-6469.2022.10.004
中文关键词: 质谱分析法  等离子气体  人参皂苷类  电感耦合等离子体质谱法( ICP-MS)  血塞通注射液  无机元素  主成分分析  风险评估
英文关键词: Massspectrometry  Plasmagases  Ginsenosides  Ductivelycoupledplasmamassspectrometry(ICP-MS)  Xuesaitong injection  Inorganic elements  Principal component analysis  Risk assessment
基金项目:河北省中医药管理局科研计划项目( 2021218)
作者单位E-mail
王冰 河北省药物警戒中心河北石家庄050090  
曹春琪 河北省药品医疗器械检验研究院河北石家庄 050200  
冯亚楠 河北省药物警戒中心河北石家庄050090  
李冬梅 河北省药物警戒中心河北石家庄050090  
刘永利 河北省药品医疗器械检验研究院河北石家庄 050200 liuyongli2008@126.com 
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中文摘要:
      目的测定血塞通注射液中 40种无机元素的含量,并进行风险评估。方法 2018年 2月至 2022年 6月,建立电感耦合等离子体质谱法( ICP-MS)测定血塞通注射液中无机元素含量的方法,测定样品中 40种元素含量,通过特征图谱及化学计量学方法分析数据,使用危害识别、危害特征描述、暴露评估和风险特征描述的方法进行风险评估。结果建立的测定方法线性、灵敏度、准确性良好;共检出 26种无机元素,特征图谱显示不同企业样品差异明显,但趋势基本一致;风险评估结果表明血塞通注射液健康风险较低。结论血塞通注射液中无机元素之间存在一定的相互作用,应重点关注与有害元素表现出极显著性正相关的 Na、K、Mg等元素;血塞通注射液正常使用剂量不会对正常人群产生不可接受的健康风险。
英文摘要:
      Objective To determine the content of 40 inorganic elements in Xuesaitong injection, summarize its composition charac. teristics and common rules, and carry out risk assessment.METHODS February 2018 to June 2022,ICP-MS was established to de. termine the content of inorganic elements in Xuesaitong injection, and the contents of samples from different enterprises were deter.mined. Hazard identification, hazard characterization, chemometrics analysis and risk characterization were used for risk assessment.Results The ICP-MS method for the determination of 40 inorganic elements in Xuesaitong injection was established with good lineari.ty, sensitivity and accuracy. A total of 26 inorganic elements were detected, and characteristic atlas of inorganic elements in Xuesaitong injection showed obvious differences among samples from different enterprisesThe health risk of heavy metals and harmful elements inXuesaitong injection was low.Conclusion There is some interaction between inorganic elements in Xuesaitong injection, and more at.tention should be paid to the elements such as Na, K and Mg, which showed highly significant positive correlation with harmful ele.ments . Normal dosage of Xuesaitong injection would not cause unacceptable health risk to the normal population.
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