X射线荧光光谱法测定右旋糖酐铁片剂中铁的含量
收稿日期: 2025-02-19
修回日期: 2025-10-11
录用日期: 2026-05-26
网络出版日期: 2026-05-26
Determination of the Content of Iron in Iron Dextran Tablets by X-ray Fluorescence Spectrometry
Received date: 2025-02-19
Revised date: 2025-10-11
Accepted date: 2026-05-26
Online published: 2026-05-26
目的:建立一种测定右旋糖酐铁片、右旋糖酐铁分散片中铁含量的X射线荧光光谱法。方法:采用能量色散型X射线荧光光谱法测定10批次右旋糖酐铁片、右旋糖酐铁分散片中铁元素含量。元素分析谱线为Fe KA,测量电压为20 kV,电流为254 μA,介质为空气,测量体积为10 mL,测试时间为200 s。结果:铁元素计数率的比值在5~100 μg·mL-1浓度范围内存在良好线性关系(R2>0.9999),平均回收率为100.65%,检出限为0.358 μg·mL-1,定量限为1.19 μg·mL-1。测定了3个厂家共10批样品,结果均在99.0%~100.5%,和原标准使用的方法(直接滴定法或原子吸收法)测定结果比较,无显著性差异。结论:本方法操作简便,精密度高,准确可靠,可用于快速测定右旋糖酐铁片、右旋糖酐铁分散片中铁的含量。
张蓉琴
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X射线荧光光谱法测定右旋糖酐铁片剂中铁的含量
Objective: To establish a method for determination of the content of iron in iron dextran tablets and iron pextran dispersible tablets by X-ray fluorescence spectrometry. Methods: The content of iron in 10 batches of iron dextran tablets and iron dextan dispersible tablets was determined by energy dispersive X-ray fluorescence spectrometry. The spectrum of elemental analysis are Fe KA. The voltage is 20 kV, the current is 254 μA, the medium is air, the measured volume is 10 mL, and the measured time is 200 s. Results: The ratio of iron element counting has a good linearity (R2>0.9999)in the concentration ranged of 5 to 100 μg·mL-1. The average recoveries was 100.65%. The limit of detection was 0.358 μg·mL-1, and the limit of quantitation was 1.19 μg·mL-1. The contents of 10 batches of samples from three pharmaceutical factories were determined, all ranging from 99.0% to 100.5%. Compared with the results obtained by the methods specified in the original standard (direct titration method or atomic absorption method), no significant difference was observed. Conclusion: This method is simple,accurate, and reliable, which could be utilized for the rapid determination of the content of iron in iron dextran tablets and dispersion tablets.
[1] 胡云云.右旋糖酐铁分散片在缺铁性贫血中的治疗效果分析[J].现代诊断与治疗,2023,34(13):1944-1946.
[2] 戴思奇.右旋糖酐铁片治疗妊娠期缺铁性贫血的临床疗效[J].临床合理用药,2020,13(6C):105-106.
[3] 陈艳.右旋糖酐铁片治疗儿童缺铁性贫血的疗效观察[J].中国城乡企业卫生,2018,33(7):61-63.
[4] 张帆,王志萍.右旋糖酐铁分散片治疗妊娠期缺铁性贫血的应用效果[J].中国当代医药,2021,28(27):140-142,146.
[5] 国家药典委员会.中华人民共和国药典[S]二部.北京:中国医药科技出版社, 2020:206-207.
[6] 国家药典委员会.中华人民共和国药典[S]二部.北京:中国医药科技出版社, 2025:218.
[7] 孟蕾,韩平,王世芳,等.X射线荧光光谱在土壤重金属检测中的应用进展[J].食品与机械,2017,33(8):210-213.
[8] 李飞燕.关于X射线荧光光谱分析仪的应用实践[J].中国有色金属,2018,(S1):359-364.
[9] 龚少.基于X射线荧光光谱技术的矿山矿物成分分析[J].世界有色金属,2024,(9):34-36.
[10] 董娇,李乃洁,刘功岩,等.X射线荧光光谱法测定锌合金中铜和铝的含量[J].品牌与标准化,2024,(1):21-23.
[11] 汤兰兰.冶金合金化学成分分析中X射线荧光光谱技术的应用研究[J].冶金与材料,2024,44(3):94-96.
[12] 吴梅,侯小敏,章群丹.石油焦中微量元素含量的测定[J].石油炼制与化工,2023,54(11):109-116.
[13] 陈远盘.X射线荧光光谱分析综述[J].分析化学,1979,7(4):304-312.
[14] 陈远盘.X射线荧光光谱分析动态[J].上海有色金属,1980,(S1):56-61.
[15] 宋苏环,黄衍信.波长色散型X射线荧光光谱仪与能量色散型X射线荧光光谱仪的比较[J].现代仪器使用与维修,1998,(4):26-27.
[16] 周国兴,赵恩好,岳明新,等.X射线荧光光谱仪及其分析技术的发展[J].当代化工,2013,42(8):1169-1172.
[17] 张银,张蓉琴.X射线荧光光谱法快速测定葡萄糖酸锌口服溶液中锌含量[J].广州化工,2025,54(18):109-111,117.
[18] 周继新.关于氧化还原滴定中的滴定误差[J].武汉师范学院学报(自然科学版),1979,(00):61-68.
[19] 张大伦,龚惠成.容量分析的滴定误差[J].武汉化工学院学报,1984,(Z1):67-74.
[20] 邓勃.t检验在分析测试中的应用[J].分析测试通报,1985,4(2):51-57.
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