中药保济丸中氧化铁的含量及限量标准讨论  

Determination of the Ferric Oxide Content in Traditional Chinese Me dicine BaoJi Pills and Discussion on the Limit Standard

作　　者：汪建君 黄澜 黄惠琼 李玲玲 WANG Jian-jun;HUANG Lan;HUANG Hui-qiong;LI Ling-ling(Xiamen Institute for Food and Drug Quality Control,Xiamen 361012,China)

机构地区：[1]厦门市食品药品质量检验研究院,福建厦门610041

出　　处：《海峡药学》2022年第4期73-75,共3页Strait Pharmaceutical Journal

摘　　要：目的建立原子吸收火焰法测定保济丸中氧化铁的含量,综合评价保济丸的内在质量。方法采用浓硝酸-微波消解样品,原子吸收火焰法测定保济丸中氧化铁的含量,并以菠菜标准物质为对照物质。结果检测54批不同批号的保济丸,氧化铁含量超过拟定限度的达52批,不合格率为96.3%。结论氧化铁作为药用辅料主要起着色剂和包衣材料的作用,大剂量使用,将产生潜在的用药风险,应引起药品生产企业及药品监管部门的重视。OBJECTIVE To establish a determination method of ferric oxide in BaoJi pills by FAAS,evaluating the quality of BaoJi pills.METHODS The samples were digested by HNO_(3)-microwave,flame atomic absorption spectrometry was used to determine the level of ferric oxide in BaoJi pills,and spinach standard matter was taken as control.RESULTS 54 different batches of BaoJi pills were determined,the content of ferric oxide in 52 batches exceeded the limit,the disqualification was 96.3%.CONCLUSION As medicinal adjuvant,ferric oxide is used as colorant and coating material,overuse may cause potential risk,which should be revoked by drug manufacturers and drug administrations.

关 键 词：中药 保济丸 氧化铁 限量标准 

分 类 号：R284[医药卫生—中药学]