| 红景天注射液中5-羟甲基糠醛HPLC含量检测方法的建立及分析 |
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| 引用本文： | 刘雪涵1,朱雯1,秦楠1,董林毅1,段宏泉1,2. 红景天注射液中5-羟甲基糠醛HPLC含量检测方法的建立及分析[J]. 天津医科大学学报, 2019, 0(6): 659-661+665 |
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| 作者姓名： | 刘雪涵1 朱雯1 秦楠1 董林毅1 段宏泉1 2 |
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| 作者单位： | （1.天津医科大学药学院，天津市临床药物关键技术重点实验室，天津 300070；2.天津医科大学基础医学研究中心，天津 300070） |
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| 摘 要： | 目的:建立红景天注射液中5-羟甲基糠醛高效液相色谱（HPLC）含量检测方法，进一步分析多批次红景天注射液中5-羟甲基糠醛的含量，评价其安全性。方法:采用Agilent XDB-C18（250 × 4.6 mm，5 μm）色谱柱，0.01%磷酸水溶液为流动相，流速为1.0 mL/min；检测波长为284 nm；柱温为30 ℃。结果:建立了HPLC检测红景天注射液中5-羟甲基糠醛含量的方法，经方法学考察，符合要求。进一步分析表明，34批次红景天注射液中5-羟甲基糠醛含量范围为1.321~6.927 μg/mL，均低于药典规定的葡萄糖注射液中的5-羟甲基糠醛限量标准。结论:多数批次的红景天注射液中均含有微量的5-羟甲基糠醛，但根据临床用量比较，远小于葡萄糖注射液中5-羟甲基糠醛的限量标准，其安全性具有足够的保障。
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| 关 键 词： | 红景天注射液 高效液相色谱 5-羟甲基糠醛 |
Establishment and Analysis of HPLC Method for Determination of 5-Hydroxymethylfurfural in Hongjingtian Injection |
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| LIU Xue-han1,ZHU Wen1,QIN Nan1,DONG Lin-yi1,DUAN Hong-quan1,' target="_blank" rel="external">2. Establishment and Analysis of HPLC Method for Determination of 5-Hydroxymethylfurfural in Hongjingtian Injection[J]. Journal of Tianjin Medical University, 2019, 0(6): 659-661+665 |
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| Authors: | LIU Xue-han1,ZHU Wen1,QIN Nan1,DONG Lin-yi1,DUAN Hong-quan1,' target=" _blank" rel=" external" >2 |
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| Affiliation: | （1. School of Pharmacy, Tianjin Key Laboratory on Technologies Enabling Development of Clinical Therapeutics and Diagnostics (Theranostics), Tianjin Medical University, Tianjin 300070, China; 2. Research Center of Basic Medical Sciences, Tianjin Medical University, Tianjin 300070, China） |
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| Abstract: | Objective: To establish a HPLC method for the determination of 5-hydroxymethylfurfural in Hongjingtian injection, further analyze the content of 5-hydroxymethylfurfural in multiple batches of Hongjingtian injection and evaluate its safety. Methods: The HPLC analysis was performed on Agilent XDB C18 (4.6 mm×250 mm，5 μm) and the mobile phase consisted of 0.01% phosphoric acid aqueous solution at a flow rate of 1.0 mL·min-1．The detective wavelength was set at 284 nm and the column emperature was maiutain at 30 ℃．Results: The HPLC method for content determination of 5-hydroxymethylfurfural in Hongjingtian injection was established, which was tested by method and met the requirements． Further analysis shows that the content of 5-hydroxymethylfurfural in 34 batches of Hongjingtian injection was in the range of 1.321~6.927 μg/mL, which was lower than the standard of 5-hydroxymethylfurfural in glucose injection prescribed by pharmacopoeia. Conclusion: Most of the batches of Hongjingtian injection contain a small amount of 5-hydroxymethylfurfural, but according to the clinical dosage, it is much smaller than the limit of 5-hydroxymethylfurfural in glucose injection, and its safety is sufficient. |
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| Keywords: | Hongjingtian injection HPLC 5-hydroxymethylfurfural |
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