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Method for determining unstable iron content in iron and carbohydrate complex

A technology of carbohydrates and carbohydrates, applied in the measurement of color/spectral characteristics, material analysis by observing the influence of chemical indicators, and analysis by making materials undergo chemical reactions, etc., can solve the problem of unstable iron content methods and other problems to achieve high accuracy, high detection sensitivity, and good precision

Active Publication Date: 2014-12-24
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the above methods only involve the basic principles of iron content determination, and there will still be large deviations in the actual determination of specific substances under different conditions
There is no report on the determination of unstable iron content in iron intravenous preparations

Method used

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  • Method for determining unstable iron content in iron and carbohydrate complex
  • Method for determining unstable iron content in iron and carbohydrate complex
  • Method for determining unstable iron content in iron and carbohydrate complex

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Preparation of iron stock solution (100μg / ml): accurately weigh crystalline ferric ammonium sulfate [FeNH 4 (SO 4 ) 2 〃12H 2 O] (Aladdin Industrial Corporation) 0.860g, dissolve in deionized water, add 2.0ml of concentrated sulfuric acid (AR), transfer to a 1L volumetric flask and dilute to the mark with deionized water as a stock solution.

[0044] Preparation of iron standard series solution: Pipette 5, 10, 20, 30, 40ml of iron stock solution respectively, add them to a 100ml volumetric flask, add deionized water to the mark, shake up as the iron standard series solution, the concentrations are respectively 5, 10, 20, 30, 40μg / ml.

[0045] The iron standard curve is established: at room temperature, add 100μl each of the iron standard series solution into a 1.5ml EP tube, then add 700μl of an aqueous solution containing 200mM citric acid (reagent I), and finally add an aqueous solution containing 150mM ascorbic acid and 6mM ferroazine ( Reagent II) 350μL, after 60min react...

Embodiment 2

[0052] Establishment of iron standard curve: same as in Example 1.

[0053] Detection method of unstable iron content in sodium iron gluconate preparation: similar to Example 1, except that when human serum is incubated with sodium iron gluconate sucrose complex injection, the amount of iron added is converted to a serum iron concentration of 100.0μg / mL. Take the same batch of sodium ferric gluconate preparation samples and repeat the experiment process 5 times for measurement and data calculation. The results are shown in Table 2.

[0054] Table 2

[0055]

Embodiment 3

[0057] Establishment of iron standard curve: similar to Example 1, except that sorbitol was used instead of ascorbic acid in reagent II.

[0058] Detection method of unstable iron content in sodium iron gluconate preparation: similar to Example 1, except that when human serum is incubated with sodium iron gluconate sucrose complex injection, the amount of iron added is converted to a serum iron concentration of 40.0μg / mL, CHAPS (Shanghai Haoyang Biotechnology Co., Ltd.) was used instead of thiourea in reagent I, and sorbitol was used instead of ascorbic acid in reagent II. Take the same batch of sodium ferric gluconate preparation samples and repeat the experiment process 5 times for measurement and data calculation. The results are shown in Table 3.

[0059] table 3

[0060]

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Abstract

The invention provides a method for determining the unstable iron content in an iron and carbohydrate complex. The method comprises the steps of enabling the iron and carbohydrate complex to be in contact with human serum and reducing unstable iron which is combined with the human serum into ferrous iron; performing action on the ferrous iron obtained through reduction and a chromogenic agent to generate a colored compound and measuring the absorbance of the colored compound; performing comparison with the iron standard liquid through the same reduction and chromogenic reaction treatment and obtaining the unstable iron content in the iron and carbohydrate complex through calculation. According to the method for determining the unstable iron content in the iron and carbohydrate complex, the detection sensitivity is high, the precision is good, the accuracy is high, the unstable iron content in the iron and carbohydrate complex can be rapidly, accurately and quantitatively determined, the quality of iron supplements, particularly intravenous iron supplements, can be scientifically and effectively controlled, and the safety of clinical medication is ensured.

Description

Technical field [0001] The invention relates to an analysis method for iron supplement preparations, in particular to a method for determining the content of unstable iron (III) in an iron-carbohydrate complex. Background technique [0002] Iron is one of the indispensable trace elements in the human body. It is an important component of hemoglobin, myoglobin, cytochrome and a variety of oxidases. It acts as a carrier of oxygen to ensure the normal delivery of oxygen in body tissues. [0003] Iron is absorbed or taken up in many tissues and cells through the classic transferrin (transferrin, Tf) and transferrin receptor (transferrin receptor, TfR) pathways, that is, trivalent iron first binds to Tf, and the combination of the two The substance then binds to the TfR on the cell surface, and then undergoes the steps of endocytosis, acidification, release and translocation. Iron enters the cytoplasm and is finally used by the cell to synthesize hemoglobin and other substances. [0004]...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/78G01N21/31
Inventor 赵俊陈祥峰蔡继兰宗在伟于欢金雪锋李艳芝刘留成
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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