珍珠明目滴眼液中16种元素的测定与分析

目的:考察原料的质量和制剂工艺对珍珠明目滴眼液中微量元素的影响,为制剂质量控制和质量安全提供依据。方法:采用微波消解电感耦合等离子体质谱法(inductively coupled plasma mass spectrometry,ICP-MS),对7批珍珠(层、母)粉和7家企业102批珍珠明目滴眼液样品中的铅、镉、砷、汞、铜、镁、铝、钾、钙、铬、锰、锌、锶、钯、钡、钨16种微量元素的含量进行测定。结果:各元素呈现良好的线性关系(r0.999),回收率在78.6%~97.6%,RSD在2.5%~9.5%,表明该方法准确可靠。结论:结果显示部分样品砷汞含量超标;少数企业成品中微量元素含量与其他企业存在明显的差异,且同一企业生产的成品微量元素含量也存在较大波动。

Quantitative Determination of 16 Elements in Zhenzhu Mingmu Eye Drops

Objective: To investigate the effects of pharmaceutical technology and the quality of raw material on trace elements contents in Zhenzhu Mingmu eye drops, and provide information for the quality control and quality safety of this preparation. Method: The contents of Pb, Cd, As, Hg, Cu, Mg, Al, K, Ca, Cr, Mn, Zn, Sr, Pd, Ba, W in 102 batches of Zhenzhu Mingmu eye drops from 7 manufacturers were determined by inductively coupled plasma mass spectrometry (ICP-MS) method. Result: Various elements showed good linear relationship (r>0.999), and the recovery rate was within 78.6%-97.6%, RSD within 2.5%-9.5%, indicating the quantitative method was accurate and reliable. Conclusion: The results showed that the contents of As and Hg in some samples exceeded the recommended limits; the content of trace elements in products of few enterprises were quite different among the samples from other manufacturers, and the obvious fluctuation was even existed for the products from the same manufacturer.