固本安神胶囊中5种重金属和有害元素残留量测定及健康风险评估  

Residual Quantity and Health Risk Assessment of 5 Heavy Metals and Harmful Elements in Guben Anshen Capsules

作　　者：张玉昆[1] 郭珊珊 牛雯颖[1] 冯月男[1] 卞敬琦[1] ZHANG Yukun;GUO Shanshan;NIU Wenying;FENG Yuenan;BIAN Jingqi(Heilongjiang University of Chinese Medicine,Harbin,Heilongjiang,China 150040;Cangzhou People’s Hospital,Cangzhou,Hebei,China 061000)

机构地区：[1]黑龙江中医药大学,黑龙江哈尔滨150040 [2]河北省沧州市人民医院,河北沧州061000

出　　处：《中国药业》2020年第17期9-12,共4页China Pharmaceuticals

基　　金：国家自然科学基金[81703981];黑龙江中医药大学校科研基金资助项目[201739];黑龙江省高校基本科研业务费支持计划项目[2017PT07]。

摘　　要：目的完善固本安神胶囊的质量标准和安全评价体系,并对服用固本安神胶囊可能产生的健康风险进行评估。方法采用原子吸收分光光度法,通过氢化物发生原子化器、石墨炉原子化器、火焰原子化器分别对固本安神胶囊细粉中的砷(As)、汞(Hg)、铅(Pb)、镉(Cd)、铜(Cu)5种重金属及有害元素的残留量进行检测;采用目标危险商值(THQ)评估健康风险。结果固本安神胶囊中As,Hg,Pb,Cd,Cu 5种元素的残留量分别为0.230,0.055,2.060,0.033,7.370 mg/kg,均符合2015年版《中国药典(一部)》的限量要求;健康风险评估结果显示,固本安神胶囊不会对人体造成明显的健康影响,其中Pb元素的THQ>0.0032,可能会对人体健康产生一定风险。结论固本安神胶囊中As,Hg,Pb,Cd,Cu 5种重金属及有害元素残留量符合国家标准要求。在批量生产时,应严格限制处方中各中药材中Pb元素的内控标准,以防对患者的健康产生潜在风险。Objective To improve the quality standard and the safety evaluation system of the Guben Anshen Capsules,and to evaluate the health risks of taking Guben Anshen Capsules.Methods The residual quantity of the elements of As,Hg,Pb,Cd,Cu were detected by atomic absorption spectrophotometry,and the probability of health risk was evaluated by using the target risk quotient value(THQ)model.Results The residual quantity of As,Hg,Pb,Cd,Cu in Guben Anshen Capsules were 0.230,0.055,2.060,0.033,7.370 mg/kg respectively,which all met the limit requirements of the 2015 edition of Chinese Pharmacopoeia for the above five elements.The result of health risk assessment suggested that Guben Anshen Capsules would not cause significant health effects on human body,while Pb element THQ>0.0032 might be of some risk to human health.Conclusion The residual heavy metals and the residual harmful elements of As,Hg,Pb,Cd,Cu in Guben Anshen Capsules meet the requirements of the national standards.In mass production,the internal control standards of the Pb element in the traditional Chinese medicinal materials in the prescription should be strictly limited to prevent potential risks to the patient’s health.

关 键 词：固本安神胶囊 风险评估 重金属 有害元素 铅 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学]