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Determination method of polysaccharide distribution in ferrosugar complex

A method of determination and complex technology, applied in the field of medicine, can solve problems such as difficult elution, interference, and lack of ultraviolet detection signals in capillary electrophoresis, and achieve high sensitivity and effective separation

Pending Publication Date: 2022-06-03
JIANGSU AOSAIKANG PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] At present, it is relatively difficult to determine the distribution of polysaccharides in polysaccharide-iron complexes.
One of the existing sugar analysis methods is chromatography, and the other is enzymatic method. Although the enzymatic method has high sensitivity and specificity, it is easily interfered by pollutants in the sample, and the source of the enzyme is complicated, and the purification is relatively difficult. Difficult, so chromatography is currently the main method for detecting and separating sugars
However, in the gas chromatography analysis method, the sample treatment is cumbersome; the liquid chromatography mainly uses pre-column derivatization and then uses ultraviolet and fluorescence detection, and abnormal phenomena often interfere with the determination in the quantitative detection; in the affinity chromatography, some glycoprotein oligosaccharides The chain has high affinity and is difficult to elute; the capillary electrophoresis method lacks a direct ultraviolet detection signal; and the biggest advantage of the ion chromatography method is that it does not require pre-derivatization and the sensitivity of the amperometric detector is high, and sugars at the ppm level can be detected. Amperometric detectors can also produce positive response values ​​to amino acids, peptides or organic acids, but there is no report on the use of ion chromatography to determine the distribution of polysaccharides in iron-glycoside complexes
[0004] Due to the diversity of sugar types and structures, it is difficult to use an accurate analytical method to qualitatively and quantitatively analyze a sugar at this stage, but with the development of ion chromatography in the qualitative and quantitative analysis of sugar distribution, in Greatly improved separation power in the determination of oligosaccharides and polysaccharides

Method used

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  • Determination method of polysaccharide distribution in ferrosugar complex
  • Determination method of polysaccharide distribution in ferrosugar complex
  • Determination method of polysaccharide distribution in ferrosugar complex

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Preparation of sample solutions:

[0036] Take the ferrose complex sample 50 μl to 50 ml in a measuring flask with a pipette, dilute with water to the scale, mix well, and use it as a sample solution after passing through a 0.22 μm water film.

[0037]The above-mentioned ferrose complex sample is carboxy maltose iron injection, wherein the Fe content (in terms of Fe element) is 50mg / ml, and the dextrin content (in terms of glucose) is 7wt% ~ 8wt%, from Jiangsu Aosaikang Pharmaceutical Co., Ltd., the production batch number of the 3 groups of samples is shown in Table 1:

[0038] Table 1

[0039] Sample 1 Sample 2 Sample 3 Production lot number 180301 20200508-1 20200508-2

[0040] Preparation of mobile phase solutions:

[0041] (1) Preparation of 250mmol / L NaOH solution: take 10ml of NaOH solution with a mass percentage content of 50%, dilute to 500mL with water, stir evenly, and pass 0.22 micron water film into a mobile phase bottle;

[0042] (2) 10...

Embodiment 2

[0044] Ion chromatography instrument selection and parameter setting:

[0045] Instrument model: Thermo-Fisher ICS-5000+

[0046] Column Name: CarboPac PA200 3*50mm Guard

[0047] Analysis column name: CarboPac PA200 3*250mm Analytical

[0048] Column temperature: 30 °C

[0049] Electrochemical detector parameter setting:

[0050] Ampere parameters (amperometric detector) electrode material: gold electrode

[0051] Reference electrode: Ag / AgCl

[0052] Potential waveform: Sugar four potential waveform

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Abstract

The invention provides a determination method of polysaccharide distribution in a ferrosugar complex. The determination method comprises three steps of preparation of a sample solution, preparation of a mobile phase solution and detection by an integral pulse amperometry. According to the determination method, the ion chromatography is matched with the amperometric detector, the polysaccharide distribution can be detected, the sensitivity is high, and the detection limit can reach the ppm level.

Description

Technical field [0001] The present invention belongs to the field of medical technology, in particular, the present invention relates to a method for determining the distribution of polysaccharides in a ferrose complex. Background [0002] Polysaccharide iron complex (also known as ferrose complex) is a macromolecular polysaccharide iron complex with a high iron content. As an iron supplement, it can rapidly increase blood iron levels and increase hemoglobin. [0003] At present, it is relatively difficult to determine the distribution of polysaccharides in polysaccharide iron complexes. The existing sugar analysis methods are one is chromatography, one is enzymatic method, although the enzymatic method has high sensitivity and specificity, but it is susceptible to interference from contaminants in the sample, and the source of the enzyme is complex, purification is also more difficult, so chromatography is the main method of detecting and isolating sugar. However, in gas chromat...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/64
CPCG01N30/02G01N30/64
Inventor 林国强冯陈国张署盛伏一凡刘霞王玲昀赵霞杨瑞峰
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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