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目的:测定不同厂家生产的国药准字号牛黄解毒片中重金属元素(Cu、Pb、Cd、As及Hg)的含量,制定其限量标准,为补充《中国药典》中牛黄解毒片的重金属检查项目和检验方法,进一步完善牛黄解毒片质量标准奠定基础。方法:用微波消解法对牛黄解毒片样品进行消解,各元素采用石墨炉原子吸收光谱法(Cu、Pb、Cd)和氢化物发生-原子吸收光谱法(As、Hg)进行测定。结果:牛黄解毒片中Cu、Pb、Cd、As及Hg元素含量的平均值和总金属含量分别为5.05、3.65、0.428、7.75、0.038、3.38mg.kg-1。结论:牛黄解毒片中Cu、Pb、Cd、As及Hg元素含量限度值分别暂定为不得过6.06、4.38、0.513、9.31及0.046mg.kg-1,总重金属元素含量限度值暂定为不得过4.06mg.kg-1。
OBJECTIVE: To determine the contents of heavy metal elements (Cu, Pb, Cd, As and Hg) in Zhunzi Niuhuangjiedu tablets produced by different manufacturers and to develop the limited standards. In order to supplement the heavy metals inspection items of Niuhuang Jiedu tablets in “Chinese Pharmacopoeia” and Test methods, to further improve the quality standard Niuhuangjiedu film laid the foundation. Methods: Samples of Bezoar detoxification tablets were digested by microwave digestion. The contents of each element were determined by graphite furnace atomic absorption spectrometry (Cu, Pb, Cd) and hydride generation - atomic absorption spectrometry (As, Hg). Results: The average contents of Cu, Pb, Cd, As and Hg in Niuhuangjiedu tablets were 5.05,3.65,0.428,7.75,0.038,3.38mg.kg-1 respectively. Conclusion: The contents of Cu, Pb, Cd, As and Hg in Niuhuangjiedu tablets are tentatively set at 6.06, 4.38, 0.513, 9.31 and 0.046 mg.kg-1, respectively. The total content of heavy metals Over 4.06 mg.kg-1.