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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(r>0.999),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。
Objective: To investigate the quality of raw materials and preparation process on the impact of trace elements in pearl eye drops, for the preparation of quality control and provide the basis for quality and safety. Methods: Seven batches of pearl (layer and mother powder) and 102 batches of pearl eyesight eye drops from 7 enterprises were analyzed by inductively coupled plasma mass spectrometry (ICP-MS) The contents of 16 trace elements including cadmium, arsenic, mercury, copper, magnesium, aluminum, potassium, calcium, chromium, manganese, zinc, strontium, palladium, barium and tungsten were measured. Results: The results showed that each element showed a good linear relationship (r> 0.999). The recoveries ranged from 78.6% to 97.6% with RSD ranging from 2.5% to 9.5%, indicating that the method is accurate and reliable. Conclusion: The results showed that the arsenic and mercury contents of some samples exceeded the standard. The contents of trace elements in the finished products of some enterprises were significantly different from those of other companies. The content of trace elements in finished products produced by the same company also fluctuated greatly.