Method for measuring 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 non-dissolution measurement, high concentration of the solution to be tested, and expensive instruments, so as to achieve scientific and reasonable product quality and ensure scientific drug use , strong specific effect
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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 two appendix IVA), 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 referen...
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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