明胶空心胶囊中7种元素含量测定方法的建立与应用
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篇名: 明胶空心胶囊中7种元素含量测定方法的建立与应用
TITLE:
摘要: 目的:为明胶空心胶囊质量的提高提供参考。方法:采用原子荧光光度法测定明胶空心胶囊中汞、砷的含量,石墨炉原子吸收法测定铬、铅和镉的含量,火焰原子吸收法测定铜和锌的含量,并对48批市售明胶空心胶囊的7种元素含量进行测定。结果:各元素在各自的检测质量浓度范围内(铬、铅、镉、砷、汞分别为0~10、0~20、0~1.5、0~10、0~1.0 μg/L,铜、锌均为0~1.8 mg/L)线性关系良好(r≥0.996 9);铬、铅、镉、铜、锌、汞、砷检测限分别为0.065、0.007、0.011、0.004、0.010、0.108、0.004 μg/L;精密度试验的RSD均不大于2.5%(n=6);重复性试验的RSD均不大于7.5%(n=6);平均加样回收率在88.6%~109.5%之间,RSD均不大于6.7%(n=6)。48批市售样品中7种元素含量均符合2015年版《中国药典》(四部)及其他国家或组织药典或标准中的相关规定。结论:本方法灵敏度与精密度高、结果准确可靠,可用于明胶空心胶囊中铬、铅、镉、铜、锌、汞、砷7种元素的含量测定;不同厂家生产的48批明胶空心胶囊质量情况较好。
ABSTRACT: OBJECTIVE: To provide reference for improving the quality of Gelatin hollow capsule. METHODS: Atomic fluorescence spectrometry was used to determine the contents of Hg, As in Gelatin hollow capsule; graphite furnace atomic absorption spectrometry was used to determine the contents of Cr, Pb, Cd; flame atomic absorption spectrometry was used to determine the contents of Cu, Zn; and the contents of 7 elements in 48 batches of commercially available Gelatin hollow capsule were determined. RESULTS: Each element showed good linear relationship in each mass concentration range (Cr, Pb, Cd, As and Hg were respectively 0-10, 0-20, 0-1.5, 0-10, 0-1.0 μg/L; Cu and Zn were 0-1.8 mg/L) (r≥0.996 9). The detection limits of Cr, Pb, Cd, Cu, Zn, Hg and As were 0.065, 0.007, 0.011, 0.004, 0.010, 0.108, 0.004 μg/L, respectively. RSDs of precision tests were no more than 2.5% (n=6); RSDs of reproducibility tests were no more than 7.5% (n=6); average recoveries ranged in 88.6%-109.5% (RSD≤6.7%, n=6). The contents of 7 elements in the 48 batches of samples were in line with the relevant provisions in Chinese Pharmacopoeia (2015 edition, part 4) and pharmacopoeia or standards in other countries or organizations. CONCLUSIONS: The method shows high sensitivity, high precision with accurate and reliable results, and can be used for the content determination of Cr, Pb, Cd, Cu, Zn, Hg and As in Gelatin hollow capsule. The 48 batches of Gelatin hollow capsule from different manufacturers have good quality.
期刊: 2017年第28卷第28期
作者: 王发英,吴查青
AUTHORS: WANG Faying,WU Chaqing
关键字: 明胶空心胶囊;元素;原子荧光光度法;石墨炉原子吸收法;火焰原子吸收法;市售样品
KEYWORDS: Gelatin hollow capsule; Element; Atomic fluorescence spectrometry; Graphite furnace atomic absorption spectrometry; Flame atomic absorption spectrometry; Commercially available samples
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