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Method for determining dissolution rate of polysaccharide-iron complex by using ultraviolet-visible spectrophotometry

A spectrophotometry and dissolution technology, which is applied in the measurement of color/spectral properties, etc., to achieve the effect of strong specificity, scientific and reasonable product quality, and guarantee of scientific drug use

Inactive Publication Date: 2014-04-23
SHANGHAI PHARMA GRP QINGDAO GROWFUL PHARMA CO LTD
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  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no method for determining the dissolution rate of polysaccharide-iron complex, and there is no dissolution quality standard for the domestic registration standard of the original drug

Method used

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  • Method for determining dissolution rate of polysaccharide-iron complex by using ultraviolet-visible spectrophotometry
  • Method for determining dissolution rate of polysaccharide-iron complex by using ultraviolet-visible spectrophotometry
  • Method for determining dissolution rate of polysaccharide-iron complex by using ultraviolet-visible spectrophotometry

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0035] 1. Instruments and reagents

[0036] (1) Instruments: PHARMTEST610 semi-automatic dissolution apparatus, SHIMADZUUV-2550 ultraviolet-visible spectrophotometer, METTLERTOLEDOXS205 electronic balance.

[0037] (2) Reagents: The reagents used are of analytical grade, and the water is purified water.

[0038] Linear relationship investigation and standard curve preparation

[0039] Precisely measure 10ml of standard iron solution (1mg / ml), put it in a 100ml measuring bottle, add water to the mark, shake well, and use it as the reference substance stock solution. Measure 0.2, 0.5, 1, 1.5, 2, 2.5, 3ml of the reference substance stock solution respectively, put in a 100ml measuring bottle, add 2ml of 10% hydroxylamine hydrochloride solution respectively, leave it for 5nin, add 0.5% 1,10-phenanthroline solution 5ml, stand for 5min, add water to the mark, shake well, and use it as the reference solution. The above-mentioned solutions were taken, and the absorbance was measure...

experiment example 2

[0042] Experimental Example 2 Precision Test

[0043]Take the polysaccharide iron complex product (batch number 130603), 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 law , After 45 minutes, take 10ml of the solution, filter, and take the filtrate as the stock solution of the test solution. In the same dissolution vessel, 6 consecutive samples were taken. According to the ultraviolet-visible spectrophotometry (Chinese Pharmacopoeia 2010 edition two appendix IVA) and quality standards, the absorbance was measured at a wavelength of 510nm. The average value of the measured absorbance of 6 samples was 0.354, and the RSD was 0.68%. See Table 2 for test data.

[0044] Table 2 precision test data

[0045]

experiment example 3

[0046] Experimental Example 3 Stability Test

[0047] Take the test solution of the polysaccharide-iron complex preparation for the dissolution test, take the absorbance of the dissolution solution for 45 minutes as the starting point (0 o'clock), according to the ultraviolet-visible spectrophotometry ("Chinese Pharmacopoeia" 2010 edition two appendix IVA), at 510nm The absorbance was measured respectively at the wavelength of 0, 1, 2, 3, 4, 6, and 8 hours. The average value of the measured absorbance was 0.347, and the RSD was 0.48%. See Table 3 for test data.

[0048] Table 3 stability test data

[0049]

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Abstract

The invention discloses a method for determining the dissolution rate of a polysaccharide-iron complex by using an ultraviolet-visible spectrophotometry. The method comprises the following steps: diluting a sample to be detected with water; dissolving for time t and filtering; adding equal reacting weight or overweight of hydrochloric acid into a filtering solution; heating to react; taking out a product after the reaction and cooling to a room temperature; then adding equal reacting weight or overweight of a hydroxylamine hydrochloride solution; after the reaction, adding a 1,10-phenanthroline solution and reacting to generate an orange complex; then determining the absorbance at the wavelength of 510nm by using the ultraviolet-visible spectrophotometry; and then calculating by a conventional method to obtain the content of iron in the sample to be detected so as to obtain the dissolution rate of the sample to be detected in the time t. The method for determining the dissolution rate of the polysaccharide-iron complex is strong in specificity, good in accuracy and practical and simple, and can be used for determining a dissolution curve and the dissolution rate so as to compare the dissolution consistency in a batch and between batches.

Description

technical field [0001] The invention relates to a method for measuring the dissolution rate of polysaccharide-iron complex by means of ultraviolet-visible spectrophotometry. 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 measuring the dissolution rate of polysaccharide-iron complexes and formulate relevant quality standards. Contents of the invention [0003] The purpose...

Claims

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Application Information

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IPC IPC(8): G01N21/31G01N21/33
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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