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Measurement method of content of 5-hydroxymethylfurfural (5-HMF) in injection

A technology of hydroxymethyl furfural and a determination method, which is applied in the detection field of traditional Chinese medicine injections, can solve problems such as exceeding the standard, poor control or poor process control, and achieves the effect of a simple and convenient method

Active Publication Date: 2012-05-23
TIANJIN TASLY ZHIJIAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, the content of 5-Hydroxymethylfurfural (5HMF) has always been poorly controlled or processed in production, seriously exceeding the standard

Method used

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  • Measurement method of content of 5-hydroxymethylfurfural (5-HMF) in injection
  • Measurement method of content of 5-hydroxymethylfurfural (5-HMF) in injection
  • Measurement method of content of 5-hydroxymethylfurfural (5-HMF) in injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0108] Determination of 5-Hydroxymethylfurfural in Yiqi Fumai Freeze-dried Preparation for Injection

[0109] (1) Reagent: methanol (German MERCK chromatographically pure); ultrapure water (made by the company); chromatographic small column made by AB-8 resin column

[0110] (2) Test drug and reference substance: three batches of Yiqi Fumai freeze-dried preparation for injection, provided by Tianjin Tasly Zhijiao Pharmaceutical Co., Ltd.; -200503);

[0111] (3) Instruments: Waters Alliance high performance liquid chromatography, including 2695Separations Module quaternary pump, online vacuum degasser, autosampler, column thermostat, Waters 2996 diode array detector, Empower 2 chromatographic workstation.

[0112] (4) Chromatographic conditions

[0113] The column is Water's sysmmetry R (4.5mm×250mm, 5um) column, the column temperature is 30°C; the mobile phase is methanol-water (see Table 1), the flow rate is 1.0ml / min, the detection wavelength is 284nm, and the injection v...

Embodiment 2

[0121] Determination of 5-Hydroxymethylfurfural in 5% Glucose Infusion

[0122] (1) Reagent: methanol (German MERCK chromatographically pure); ultrapure water (made by the company); ProElut TM SPE (6ml, 0.5g, Dima Technology Co., Ltd.)

[0123] (2) Test drug and reference substance: commercially available three different brands of 5% glucose infusion for injection; 5-hydroxymethylfurfural reference substance (purchased from China Institute for the Control of Pharmaceutical and Biological Products, batch number 111626-200503);

[0124] (3) Instruments: Waters Alliance high performance liquid chromatography, including 2695Separations Module quaternary pump, online vacuum degasser, autosampler, column thermostat, Waters 2996 diode array detector, Empower 2 chromatographic workstation.

[0125] (4) Chromatographic conditions

[0126] The column is Water's sysmmetry R (4.5mm×250mm, 5um) column, the column temperature is 30°C; the mobile phase is methanol-water (see Table 1), the...

Embodiment 3

[0135] Determination of 5-Hydroxymethylfurfural in Shengmai Injection

[0136] (1) Reagent: methanol (German MERCK chromatographically pure); ultrapure water (made by the company); Cleanert TM SpE (6ml, 0.5g, Tianjin Bona Agel Technology Co., Ltd.)

[0137] (2) Test drug and reference substance: commercially available Shengmai Injection of seven different brands; 5-Hydroxymethylfurfural reference substance (purchased from China Institute for the Control of Pharmaceutical and Biological Products, batch number 111626-200503);

[0138] (3) Instruments: Waters Alliance high performance liquid chromatography, including 2695 Separations Module quaternary pump, online vacuum degasser, automatic sampler, column oven, Waters 2996 diode array detector, Empower 2 chromatographic workstation.

[0139] (4) Chromatographic conditions

[0140] The column is Water's sysmmetry R (4.5mm×250mm, 5um) column, the column temperature is 30°C; the mobile phase is methanol-water (see Table 1), the fl...

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Abstract

The invention relates to a measurement method of content of 5-hydroxymethylfurfural (5-HMF) in an injection. The measurement method comprises the following steps of: (1) pre-processing the injection to obtain a sample solution; (2) preparing a 5-HMF reference solution; (3) measuring the sample solution and the reference solution by adopting a high performance liquid chromatography (HPLC); and (4) calculating the content of the 5-HMF in the sample solution, wherein the preprocessing step comprises the procedure of passing through macroporous adsorption resin.

Description

technical field [0001] The invention relates to a method for detecting traditional Chinese medicine injections, in particular to a method for determining the content of 5-hydroxymethylfurfural in injections. Background technique [0002] 5-Hydroxymethylfurfural (also known as 5-hydroxymethyl-2-furfural, hydroxymethylfurfural, 5-hydroxymethylfurfural or 5-hydroxymethyl-2-furfural), English name 5-hydroxymethyl- 2-furfural, 5-hydroxymethyl-furfural, or 5-HMF, is a chemical substance. [0003] Injections, especially those containing sugar, often contain impurity 5-hydroxymethylfurfural. Some traditional Chinese medicine injections may also contain 5-hydroxymethylfurfural as an impurity due to sugar substances. The reason is that Chinese medicine extracts contain a large amount of sugar substances. Fructose, glucose and other sugar substances are easy to dehydrate under high temperature, and further produce 5-Hydroxymethylfurfural and polymers may cause allergies and irritatio...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/88A61K36/8968A61K9/08A61K9/19A61P43/00
Inventor 杨悦武叶正良兰淑玲周学谦周大铮
Owner TIANJIN TASLY ZHIJIAO PHARMA
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