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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[0.0092,0.0110,0.0172 mg/(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。
The concentrations of arsenic, lead, cadmium, chromium and copper in hollow capsules were determined by microwave digestion-inductively coupled plasma mass spectrometry (ICP-MS) and online calibration. The contents of heavy metals in hollow capsules were determined by risk assessment Evaluation. The results showed that: (1) The established method was simple, accurate and sensitive, and could be used for the quality control of hollow capsules. (2) The chromium exceeded the standard of 62% in 51 batch hollow capsules, × 10-6, up to 54 × 10-6; Lead 14 batches exceeded 1 × 10-6; cadmium content was lower; (3) 90%, 95%, 99% The weekly exposure [0.0092,0.0110,0.0172 mg / (kg.bw)] accounted for 278%, 333% and 521% of the PTWI [6.7-8.2 μg / (kg.bw)], respectively. Conclusion It can be seen that there is a potential risk of chromium in the hollow capsule to the human body, improving the GMP quality management standards and strengthening the risk monitoring of hollow capsules can effectively reduce their safety risks.