中药片剂中氧化铁类包衣材料的使用现状及风险评估  

Application situation and risk evaluation of iron oxide used as coating material in herb tablets

作　　者：夏晶[1] 李丽敏[1] 曹帅[1] 陈虹[1] 仇佳思 毛秀红[1] 季申[1] 

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《中成药》2015年第1期84-88,共5页Chinese Traditional Patent Medicine

摘　　要：目的测定中药片剂氧化铁类包衣材料中9种元素（铝、铬、铁、铜、砷、镉、钡、汞、铅）含有量来评估使用现状和风险。方法硝酸-盐酸（4∶1）作为消解试剂,使用微波消解仪对片剂进行前处理,ICP-MS法测定时采用在线加入内标法并开启碰撞反应池。结果在样品取样量为0.2~0.5 g时,9种元素的回收率均符合元素分析的要求,方法检测限为0.002~0.609 mg/kg。29种片剂443批中有192批含铁量超过了10 mg/d,其中90%以上铁由包衣材料产生,其他8种元素含有量无明显异常。结论从铁的健康风险指数评估中药片剂中包衣材料应考虑用其他更为安全的色素代替氧化铁类物质。AIM To determine the contents of nine elements（ Al,Cr,Fe,Cu,As,Cd,Ba,Hg,and Pb） in coating material of herb tablets to evaluate the application and risk of iron oxide. METHODS With nitric acid / hydrochloric acid（ 4 ∶ 1,V / V） as counteracting agent,tablets were digested by HNO3-microwave as pretreatment. ICP-MS was used with collision cell technology in combination with in line internal standard. RESULTS When a sample weighed 0. 2-0. 5 g,detection limits were in the range of 0. 002-0. 609 mg / kg,and their recoveries fitted with the standard of element analysis. Each iron oxide content in 192 out of 443 batches of tablets was over 10 mg / d,which mainly stemmed from coating material,and no abnormal findings were elicited on other eight elements. CONCLUSION The result indicates that it is neccesary to substitute the safer pigments for coating material containing iron oxide for the sake of administrors’ health.

关 键 词：中药片剂 氧化铁 包衣 ICP-MS 使用现状 使用范围 

分 类 号：R944[医药卫生—药剂学]