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A method for determining the dissolution rate of polysaccharide-iron complex by liquid phase method

A liquid phase method and dissolution technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of high concentration of the solution to be tested, inability to measure the dissolution rate, and expensive instruments, so as to achieve scientific and reasonable product quality and ensure scientific drug use , strong specific effect

Active Publication Date: 2016-04-06
SHANGHAI PHARMA GRP QINGDAO GROWFUL PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Titration, atomic absorption, etc. are the most common methods for iron quantification, but the titration method requires a very high concentration of the solution to be tested, and it is impossible to use it for the determination of dissolution; atomic absorption instruments are expensive, and the current utilization rate is low

Method used

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  • A method for determining the dissolution rate of polysaccharide-iron complex by liquid phase method
  • A method for determining the dissolution rate of polysaccharide-iron complex by liquid phase method
  • A method for determining the dissolution rate of polysaccharide-iron complex by liquid phase method

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0030] The selection of experimental example 1 measurement wavelength

[0031] 1. Instruments and reagents

[0032] (1) Instruments: PHARMTEST610 semi-automatic dissolution apparatus, ANGILENT1260 liquid chromatograph, SHIMADZUUV-2550 ultraviolet-visible spectrophotometer, METTLERTOLEDOXS205 electronic balance.

[0033] (2) Reagents: Methanol is chromatographically pure, water is ultrapure water, and other reagents are analytically pure.

[0034] Prepare the test solution, the reference solution and the blank control solution according to the quality standards (the blank control solution is to accurately measure 1ml of water and prepare it according to the preparation method of the test solution). The above three solutions were taken according to UV-Vis spectrophotometry (Chinese Pharmacopoeia 2010 Edition, Appendix IVA of Part II), and the absorption curves were measured at the wavelength of 200-400nm respectively. The results are shown in Table 1. The test solution and the...

experiment example 2

[0037] Experimental example 2 linear relationship investigation and preparation of standard curve

[0038]Accurately weigh the sodium ferric edetate reference substance (equivalent to 10mg iron), put it in a 100ml measuring bottle, add water to the mark, shake well, and use it as the reference substance stock solution. Measure 0.3, 0.6, 0.9, 1.2, 1.5, 1.8ml of the reference substance stock solution respectively, put in a 100ml measuring bottle, add water to the mark, shake well, and use it as the reference substance solution. Take the above-mentioned solutions, according to high performance liquid chromatography (Chinese Pharmacopoeia 2010 edition two appendix ⅤD), respectively measure the peak area at the wavelength of 256nm. With the reference substance concentration (μg / ml) as the abscissa and the peak area as the ordinate, draw a standard curve, and perform regression analysis on the measured data. The regression equation is y=76.184x+98.213, and the correlation coefficien...

experiment example 3

[0041] Experimental Example 3 Precision Test

[0042] Take the polysaccharide iron complex (batch number 130604), according to the dissolution test method ("Chinese Pharmacopoeia" 2010 edition two appendix XC first method), using 900ml of water as solvent, the number of revolutions is 100 revolutions per minute, according to the operation, after At 45 minutes, take an appropriate amount of the solution, filter it, take 1ml of the filtrate, put it in a 10ml measuring bottle, add 0.1ml of dilute sulfuric acid (10%) (specific concentration is given), heat it in a water bath until the color becomes lighter, take it out, put it in At room temperature, add 0.5ml of 0.4% disodium edetate solution, shake well, let it stand for 10min, add water to the mark, shake well, and use it as the test solution. In the same dissolution vessel, 6 consecutive samples were taken from different positions. According to high-performance liquid chromatography (Chinese Pharmacopoeia 2010 Edition, Append...

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Abstract

The invention discloses a method for measuring the dissolution rate of polysaccharide iron complex by liquid phase method. The method comprises the following steps: dissolving a test sample in water, with dissolving time t, filtering the dissolving solution, adding dilute sulfuric acid to the filtrate, heating the filtrate until the color of the filtrate is lighter, cooling the filtrate to the room temperature, adding the equal reaction amount or excess amount of ethylenediamine tetraacetic acid disodium salt solution (EDTA) into the filtrate, and after reaction is completed, measuring the reaction solution by the liquid phase method, recording the chromatogram, measuring the concentration or / and the content of the polysaccharide iron in the tested sample according to the peak area, and thus obtaining the dissolution rate of the tested sample at the dissolving time t. The actual application of the method for measuring the dissolution rate of polysaccharide iron complex by liquid phase method shows that the separation effect is good, the measurement is accurate, the sensitivity is high, the specificity is high, the analysis is simple and quick, and the method can be used for quantifying the dissolving solution of the polysaccharide iron and judging the actual dissolving situation, so as to estimate the absorption and therapeutic effect of the single batch or different batches of the medicines.

Description

technical field [0001] The invention relates to a method for measuring the dissolution rate of a polysaccharide-iron complex by using a liquid phase method. Background technique [0002] The polysaccharide-iron complex is an organic compound of low-molecular-weight polysaccharides and iron, and is a drug for treating simple iron-deficiency anemia. At present, in addition to bioequivalence experiments, the dissolution consistency is the most scientific, reasonable and effective evaluation method for judging the consistent efficacy of chemical drugs. At present, there is no method for determining the dissolution rate of polysaccharide-iron complexes, and there is no dissolution quality standard in the domestic registration standards of original drugs. Therefore, it is very necessary to develop a method for determining the dissolution rate of polysaccharide-iron complex and formulate related quality standards. Titration and atomic absorption are the most common methods for qu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 田红伟姜作玲展筱林程宏霞王冬王海清
Owner SHANGHAI PHARMA GRP QINGDAO GROWFUL PHARMA CO LTD
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