摘要
目的:建立电感耦合等离子体质谱法(ICP-MS)测定缬沙坦胶囊内容物和囊壳中Mg、Al、V、Cr、Mn、Co、Ni、Cu、As、Cd、Tl和Pb元素含量的方法,并对4种有害元素进行健康风险评估.方法:胶囊内容物和囊壳分别采用微波消解法前处理,以Sc、Ge、In、Bi为内标,ICP-MS标准曲线法测定12种金属杂质元素的含量,采用危害商值(HQ)和危害指数(HI)对Cr、Ni、Cu、Pb元素进行风险评估.结果:12种金属杂质元素标准曲线的相关系数均大于0.999.内容物的加标回收率在81.2％～113.4％之间,囊壳的加标回收率在83.2％～117.4％之间,RSD＜15％.健康风险评估结果显示内容物和囊壳中Cr、Ni、Cu、Pb元素的HI均小于1.结论:所建立的ICP-MS测定方法简单、快速、准确,可用于缬沙坦胶囊内容物及囊壳中12种金属杂质元素的含量测定,16批次缬沙坦胶囊中Cr、Ni、Cu、Pb元素的暴露值均无明显健康危害风险.
Abstract
OBJECTIVE To establish an inductively coupled plasma mass spectrometer(ICP-MS)method for the determi-nation of 12 metal impurities(Mg,Al,V,Cr,Mn,Co,Ni,Cu,As,Cd,Tl &.Pb)in the contents and capsule shell of valsar-tan capsules and conduct health risk assessments of 4 hazardous elements.METHODS The contents and shell of valsartan cap-sules were digested by microwave respectively.The contents of 12 metal impurity elements were determined by ICP-MS standard curve with Sc,Ge,In and Bi as internal standards.Moreover,hazard quotient(HQi)and hazard index(HI)were utilized for evaluating the health risk of Cr,Ni,Cu and Pb.RESULTS The correlation coefficients of calibration curves of 12 metal impurity elements were all＞0.999.The spiked recoveries of the contents ranged from 81.2％to 113.4％,And the spiked recoveries of capsule shells were between 83.2％and 117.4％with RSD＜15％.The results of health risk assessment showed that hazard index(HI)of Cr,Ni,Cu and Pb elements in contents and shells were＜1.CONCLUSION The established ICP-MS method is simple,rapid and accurate for determining 12 metal impurity elements in the contents and shells of valsartan capsules.And the exposure values of Cr,Ni,Cu and Pb in 16 batches of valsartan capsules have no significant health risk.
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