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目的建立中药制剂香砂胃灵散中10种重金属及有害元素的检测方法并测定其含量,为其质量控制提供依据。方法采用湿法消解样品,采用石墨炉原子吸收光谱法测定香砂胃灵散中10种金属元素并对测定方法进行方法学考察。结果三批香砂胃灵散中均检出铜(Cu),铅(Pb),铬(Cr),钴(Co),镉(Cd),铁(Fe),锰(Mn),银(Ag)和铝(Al)元素,但As元素的含量低于定量下限。Cu、Pb、Cr、Co、Cd、Fe、Mn、Ag和Al的平均回收率分别为99.8%、98.9%、99.0%、99.8%、99.0%、100.1%、99.7%、99.3%和101.7%。结论该方法适用于对香砂胃灵散中多种金属元素进行质量控制。
OBJECTIVE To establish a method for the determination of 10 heavy metals and harmful elements in Xiangsha Weishen Powder, and to determine its content to provide basis for its quality control. Methods Wet digestion samples were used to determine 10 kinds of metal elements in Xiangshaweiling powder by graphite furnace atomic absorption spectrometry and the methodological study was carried out. Results The results of three batches of Xiangshangweiling powder were detected in the samples of Cu, Pb, Cr, Co, Cd, Fe, Mn, Ag ) And aluminum (Al) elements, but the As element content is below the lower limit of quantitation. The average recoveries of Cu, Pb, Cr, Co, Cd, Fe, Mn, Ag and Al were 99.8%, 98.9%, 99.0%, 99.8%, 99.0%, 100.1%, 99.7%, 99.3% and 101.7%, respectively. Conclusion This method is suitable for quality control of various metal elements in Xiangsha Weishen San.