| 第 53 卷第 1 期 |  | Vol. 53 No. 1 | | 2023 年 2 月 | Feb 2023 |
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所屬欄目：分析與測試
ICP-MS測定黃原膠中汞元素含量的研究 |
| 孫花麗1，李利利1，張亮亮2，張 振2，侯衛衛1，雷 洋1，門(mén) 靖3
（1. 陜西君境邁德生物醫藥科技有限公司，陜西 西安，712100；2. 西安樂(lè )析醫療科技有限公司，陜西 西安 710304；3. 西安萬(wàn)隆制藥股份有限公司，陜西 西安 710119） |
| 摘 要：考察了藥用輔料黃原膠中具有揮發(fā)性的汞元素測定方法的穩定性與可靠性。以10 mL硝酸用一定的消解程序進(jìn)行微波消解，趕酸，加入標準金溶液，稀釋?zhuān)捎秒姼旭詈系入x子體質(zhì)譜法（ICP-MS）測定樣品中汞元素的含量，內標法定量。測試結果顯示：汞元素的質(zhì)量濃度在一定范圍內與其對應的響應值與內標響應值的比值呈線(xiàn)性關(guān)系，檢出限為0.020 4 μg/L；6份加標樣品溶液，結果相對標準偏差為11.4%；樣品加標回收試驗，回收率為87.3%~111.3%。實(shí)際樣品分析表明，汞元素含量均低于ICH Q3D規定的允許濃度限值。所建立方法專(zhuān)屬性好、靈敏度高、準確度強、結果可靠，適用于黃原膠中汞元素的測定。 |
| 關(guān)鍵詞：黃原膠；汞元素；電感耦合等離子體質(zhì)譜法；藥用輔料 |
| 中圖分類(lèi)號：O657.7 文獻標識碼：A 文章編號：1009-9212（2023）01-0092-05 |
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| Determination of Hg in Xanthan Gum by ICP-MS |
| SUN Hua-li1, LI Li-li1, ZHANG Liang-liang3, ZHANG Zhen2, HOU Wei-wei1, LEI Yang1, MEN Jing3
(1. Shaanxi Junjing Med Biomedical Technology Co., Ltd., Xi’an 712100, China; 2. Xi’an Renalysis Medical Technology Co., Ltd., Xi’an 710304, China; 3. Xi’an Wanlong Pharmaceutical Co., Ltd., Xi’an 710119, China) |
| Abstract：The stability and reliability of a method for detecting volatile mercury in Xanthan gum are investigated. 10 mL of nitric acid was microwave digestion with a certain digestion procedure, rushed acid, added standard gold solution, diluted, and the content of mercury in the sample was determined by ICP-MS, and the internal standard was quantified. The results showed: the mass concentration of mercury element had a linear relationship with the ratio of its corresponding response value to the response value of the internal standard within a certain range. The limit of detection (3.3 δ/s) was 0.020 4 μg/L; 6 spiked sample solutions, the relative standard deviation of the result was 11.4%; spiked recovery test of the sample, The accuracy result was 87.3%~111.3%. After analysis of the actual samples, the mercury levels were below the permissible concentration limits specified by ICH Q3D. This established method had good specificity, high sensitivity, strong accuracy and reliable results, and was suitable for the determination of Hg element in xanthan gum. |
| Key words：Xanthan gum; Hg element; ICP-MS; pharmaceutical excipients |
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作者簡(jiǎn)介：孫花麗（1988—），女，陜西西安人，工程師，研究方向：藥物分析和藥品質(zhì)量控制及其管理工作（E-mail：598493930@qq.com）。
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收稿日期：2022-11-22
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