9个企业复方地巴唑氢氯噻嗪胶囊壳中8种金属元素的含量分析

Analysis of the Contents of 8 Metallic Elements in Compound Bendazol and Hydrochlorothiazide Capsule Shells from 9 Manufacturers

目的：建立同时测定胶囊壳中8种金属元素（Cu、Cr、Co、Ni、As、Ag、Cd、Pb）含量的方法,并分析9个企业复方地巴唑氢氯噻嗪胶囊壳中的8种金属元素的含量。方法：采用电感耦合等离子体质谱（ICP-MS）法。样品加硝酸10 ml在150℃预消解2 h,再经微波消解处理后,分析9个企业21批胶囊壳中8种金属元素的含量。结果：8种金属元素检测质量浓度线性范围均为1-200ng/ml（r=0.999 8-1.000 0）;平均回收率为94%-105%,RSD均≤4.0%（n=6）。9个企业样品中8种金属元素均有检出,其中多数企业样品Cu、Cr和Pb含量较高但未超过标准要求,但有1个企业样品Cr含量严重超标。结论：建立的含量分析方法简单、快速、准确;建议各企业应对所用胶囊进行严格的质量控制。

OBJECTIVE： To establish a method for simultaneous determination of 8 metallic elements （Cu, Cr, Co, Ni, As, Ag, Cd and Pb） in capsule shell, and to analyze the contents of 8 metallic elements in Compound bendazol and hydrochlorothiazide capsule shells from 9 manufacturers. METHODS： The samples were pre-digested with nitric acid 10 ml at 150 ℃ for 2 hours. After processing the sample with microwave digestion system, the contents of 8 metallic elements in 21 batches of capsule shells from 9 manufacturers were analyzed by ICP-MS. RESULTS： The linear range of 8 metallic elements were 1-200 ng/ml （r=0.999 8- 1.000 0） with average recoveries of 94%-105% （RSD≤4.0%, n=6）. 8 metallic elements were all detected in capsules from 9 manufacturers. The contents of Cu, Cr and Pb in samples from most manufacturers were higher than other elements but not exceeded the standard limit. The content of Cr in samples from a manufacturer seriously exceeded the standards. CONCLUSIONS： The method is simple, rapid and accurate; it is suggested to control the quality of the capsules strictly.