ICP-MS法测定空心胶囊中重金属含量及其风险分析  

Determining of Heavy Metals of Capsules Applying ICP-MS and Its Risk Analysis

作　　者：张丽平[1] 余晓琴[2] 王颖[2] 

机构地区：[1]成都纺织高等专科学校染化系,成都611731 [2]四川省食品药品检验所,成都610097

出　　处：《食品工业》2012年第12期178-182,共5页The Food Industry

基　　金：四川省教育厅青年基金(10ZB061)

摘　　要：通过微波消解-电感耦合等离子体质谱法（ICP—MS），内标在线校正测定空心胶囊中砷、铅、镉、铬、铜五种重金属元素含量；采用风险评估理论对空心胶囊中重金属进行暴露评估。结果表明，（1）建立的方法简便、准确、灵敏度高，可用于空心胶囊的质量控制；（2）51批空心胶囊中铬超标率为62％，2批砷超过限度；4批铜超过10×10-6，最高54×10-6；铅14批超过1×10-6；镉含量均较低；（3）90％，95％，99％涵盖百分率的空心胶囊服用人群中，铬每周暴露量[0．0092，0.0110，0．0172mg／（kg·bw）]占PTWI[6．7-8．2μg／（kg·bw）]百分率最坏为278％，333％，521％。结论可知，空心胶囊中铬对人体已存在潜在风险，提高GMP质量管理规范和加强空心胶囊风险监测，可有效降低其安全风险。To establish the method of determining contents of heavy metals in capsules, analyze its potential risk on humans. An inductively coupled plasma mass spectrometry （ICP-MS） for determination of the contents of As, Cr, Cd, Cu, and Pb in capsules had been developed. The potential risk and exposure assessment of heavy metals was carried out by point assessment based on risk analysis theory. The results showed： （1） the proposed method had the advantages of simplicity, speediness and sensitivity, which met the challenge of analysis. There was no significant difference between this method and the method of determining Cr using AFS from The Chinese Pharmacopoeia （edition 2010）; （2） in fifty-one samples, the overproof rate of Cr was 62%,twelve samples were ten times of overproof; As of two samples were overproof; Cu of four samples exceeded 10 mg/kg; Pb of fourteen samples exceeded 1 mg/kg; Cd of all samples were very low; （3） the exposure dose per week of As, Cu, Pb, Cd in percentile of 90%, 95% and 99% of the taking capsules group may be ignored ,but the exposure dose per week of Cr [0.0092, 0.0110, 0.0172 mg/（kg·bw）], which worst were 137%, 164%, 257% of the PTWI [6.7-8.2 μg/（kg·bw）]. The conclusions were the potential hazard of Cr from inferior capsules was existed, and implement of improving GMP and special monitoring of capsules was useful for reducing the risk of capsules.

关 键 词：IPC—MS 重金属 空心胶囊 风险评估 

分 类 号：TQ460.1[化学工程—制药化工]