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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¹; 2

（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-quan¹; 2

（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.

参考文献/References:

[1] 国家药典委员会．中国药典(一部)[S]．北京: 中国医药科技出版社，2015：154
[2] 孟甜．红景天总鞣质的提取纯化工艺和质量标准研究[ D] ．成都：西华大学， 2010:126
[3] Liu Z L，Chao Z M，Liu Y Y，et al．Maillard reaction involved in the steaming process of the root of Polygonum multiflorum[J]． Plant Med，2009，75( 1):84
[4] 刘青，李志勇，张洋子，等．葡萄酒中5-羟甲基糠醛含量的测定[J]．酿酒科技，2016(11):107
[5] Zirbes L, Nguyen B K, De Graaf D C, et al. Hydroxymethylfurfural: a possible emergent cause of honey bee mortality [J]. J Agric Food Chem, 2013, 61(49):11865
[6] 温超，王紫梦，石星波，等．食品中丙烯酰胺与5-羟甲基糠醛的研究进展[J]．食品科学，2015，36(13)：257
[7] 赵颖，张璐欣，李越．5-羟甲基糠醛的研究概况[J]．医学综述，2016，22(17)：3431
[8] 艾则孜·穆合买提，贺玖明，孙江浩，等．中药注射液中5-羟甲基糠醛含量测定的LC -MS/MS 分析方法研究[J]．药物分析杂志，2010，30( 7)：1195
[9] 国家药典委员会．中国药典(二部)[S]．北京：中国医药科技出版社，2015:1270
[10] 贾晓斌, 王晓雷, 蔡宝昌，等．含丹参的葡萄糖注射液中5-羟甲基糠醛的检查方法研究[J].中成药，2003，3(25)：191

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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。

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更新日期/Last Update: 2020-01-20