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作 者:赵一懿[1] 郭洪祝[1] 傅欣彤[1] 陈有根[1]
机构地区:[1]北京市药品检验所中药成分分析与生物评价北京市重点实验室,北京102206
出 处:《中草药》2017年第10期1991-1997,共7页Chinese Traditional and Herbal Drugs
摘 要:目的建立银杏叶制剂中25种无机元素的电感耦合等离子体质谱(ICP-MS)分析方法,并对不同剂型银杏叶制剂中无机元素量进行比较分析。方法样品经微波消解后,采用ICP-MS法测定25种无机元素量,绘制无机元素指纹谱图,并进行方法学考察。结果 25种无机元素在各自的线性范围内线性关系良好,r≥0.950 0,精密度、稳定性和重复性试验的RSD值均符合定量分析要求;加样回收率为91.35%~108.86%,RSD在0.05%~4.45%。银杏叶制剂中检测了25种无机元素量,并绘制无机元素指纹图谱,发现其谱图具有一定的特征性;银杏叶片中元素Hg、Al、Cr的量较高,有害无机元素的量超标应引起关注。结论通过无机元素在银杏叶制剂中的组成分布及其量的变化规律研究,为银杏叶制剂的质量控制及安全性评价提供依据,同时为临床使用提供一定参考。Objective To establish a method for simultaneous analysis on the 25 inorganic elements in Ginkgo Folium preparations. The inorganic elements in Ginkgo Folium among different preparation formulations were compared by inductively coupled plasma mass spectrometry (ICP-MS). Methods The sample solutions were analyzed by ICP-MS after microwave digestion, The data were made from stacked lines of inorganic elements. Results The determination results of 25 kinds of mineral elements all had a good linear relationship, r 〉 0.950 0. The RSD values of the precision, stability, and repeatability all met the demands of quantitative analysis. The recovery was 91.35%--108.86% and RSD was 0.05%--4.45%. Twenty-five inorganic elements in Ginkgo Folium preparations were determined, and there were some correlations among the metal elements in it. The contents of rig, A1, and Cr were abundant. So the content of heavy metals and harmful elements should be caused for concern. Conclusion This experiment provides the evidence for the quality control and safety evaluation of Ginkgo Folium preparations.
关 键 词:银杏叶制剂 无机元素 电感耦合等离子体质谱法 指纹图谱 微波 质量控制 安全性评价 舒血宁注射液 银杏叶片 Ag Co Li K Ca Na Mg A1 Fe Zn Mn V Cr Be Ni Cm Ga As Se Rb Sr:Cd Cs Ba TL Pb U:Hg
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