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| 药用滑石粉酸中可溶物中杂质元素的分析及探讨 |
| Analysis and Discussion of impurity elements in Acid-soluble Substances in Medical Talc powder |
| 投稿时间：2020-04-08 修订日期：2020-07-02 |
| DOI： |
| 中文关键词: 滑石粉 酸中可溶物 金属元素杂质 扫描电子显微镜/X-射线能谱仪（能谱扫描电镜） 电感耦合等离子体原子发光光谱法（ICP-AES） |
| 英文关键词: talc acid-soluble substance metal impurity SEM/EDS ICP-AES |
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| 中文摘要: |
| 目的：通过能谱扫描电镜与ICP-AES的联合应用，考察滑石粉酸中可溶物项目控制的必要性与可行性。方法：通过扫描电子显微镜/X-射线能谱仪（SEM/EDS）对滑石粉酸中可溶物的主要金属元素构成进行分析，并采用电感耦合等离子体原子发光光谱法（ICP-AES）定量测定酸中可溶物中的钙、镁、铁等主要金属元素杂质。结果：扫描电子显微镜/X-射线能谱仪（SEM/EDS）发现滑石粉酸中可溶物普遍存在镁元素，但现行各国药典中均未对可能存在的酸溶性镁盐进行控制，增加ICP-AES测定法，对滑石粉酸中可溶的钙、镁、铁进行考察，并经方法学验证，方法可行。结论：（1）不同来源的滑石粉，酸中可溶物的金属元素含量构成比例有所不同，有必要对酸中可溶物进行控制；（2）ICP-AES可对滑石粉酸中可溶物的钙、镁、铁等主要金属元素杂质进行质量控制及评价。 |
| 英文摘要: |
| Objective：To explore the necessity and feasibility of controlling the acid-soluble substancesin talc by combined applications of scanning electron microscopy/energy dispersivex-ray spectrometry (SEM/EDS) and ICP-AES. Method： SEM/EDS was applied to analyse the components of major metal elements in acid-soluble substances in talc. Calcium, magnesium and iron contents were quantified by ICP-AES. Result: Scanning electron microscope /energy dispersive X-ray spectrometer (SEM / EDS) found that magnesium was commonly found in the acid-soluble substances of talc , but the current Pharmacopoeias did not control the magnesium in acid-soluble substances. ICP-AES method was added to investigate calcium, magnesium and iron in the acid-soluble substance of talc , and the method was verified to be feasible by methodology. Conclusion:(1) The components of metal elements in acid-soluble substances may vary depending on the origin of talc, so it is necessary for the control of acid-soluble substances in talc. (2) ICP-AES can be used for quality control and evaluation of the major metal elements, such as calcium, magnesium and iron, in acid-soluble substances in talc. |
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