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目的:测定17批跌打片样品中铜元素的含量,为该制剂的质量控制提供依据。方法:以硝酸3 ml与过氧化氢1 ml分别对17批跌打片样品进行消解,用火焰原子吸收法测定其中铜元素的含量。结果:铜离子在0~0.8μg·ml-1浓度范围内与吸光度呈良好的线性关系(r=0.999 6),其平均回收率为99.17%,RSD=0.86%(n=6)。17批跌打片样品中铜元素的含量为4.360~91.590μg/片。结论:该方法简单、准确、重复性好,可用于该制剂的质量控制。17批跌打片样品中铜元素的含量差异较大,制定合理的铜元素限度标准十分必要。
Objective: To determine the content of copper in 17 batches of samples, providing the basis for the quality control of this preparation. Methods: Seven batches of samples were digested with 3 ml of nitric acid and 1 ml of hydrogen peroxide respectively, and the contents of copper were determined by flame atomic absorption spectrometry. RESULTS: Copper ion had a good linear relationship with absorbance (r = 0.999 6) in the range of 0 ~ 0.8μg · ml-1. The average recovery rate was 99.17% and RSD was 0.86% (n = 6). The content of copper in 17 batches of samples was 4.360 ~ 91.590μg / tablet. Conclusion: The method is simple, accurate, reproducible and can be used for the quality control of the preparation. The difference between the content of copper in 17 batches of test pieces is quite large, so it is very necessary to set a reasonable limit of copper content.