|本期目录/Table of Contents|

[1]刘雪涵,朱雯,秦楠,等.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,2019,25(06):659-661+665.
 LIU Xue-han,ZHU Wen,QIN Nan,et al.Establishment and Analysis of HPLC Method for Determination of 5-Hydroxymethylfurfural in Hongjingtian Injection[J].Journal of Tianjin Medical University,2019,25(06):659-661+665.
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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(PDF)
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《天津医科大学学报》[ISSN:1006-8147/CN:12-1259/R]

卷:
25卷
期数:
2019年06期
页码:
659-661+665
栏目:
技术与方法
出版日期:
2019-11-20

文章信息/Info

Title:
Establishment and Analysis of HPLC Method for Determination of 5-Hydroxymethylfurfural in Hongjingtian Injection
文章编号:
1006-8147(2019)06-0659-04
作者:
刘雪涵1朱雯1秦楠1董林毅1段宏泉12
(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)
Author(s):
LIU Xue-han1 ZHU Wen1 QIN Nan1 DONG Lin-yi1 DUAN Hong-quan12
(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)
关键词:
红景天注射液高效液相色谱5-羟甲基糠醛
Keywords:
Hongjingtian injection HPLC 5-hydroxymethylfurfural
分类号:
R927.2
DOI:
-
文献标志码:
A
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。
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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备注/Memo

备注/Memo:
作者简介 刘雪涵(1994-),女,硕士在读,研究方向:中药现代质量控制与质量标准;通信作者:段宏泉,E-mail:duanhq@tijmu.edu.cn。
更新日期/Last Update: 2020-01-20