Method for detecting dissolution rate of colloidal bismuth pectin preparation

A technology of colloidal bismuth pectin and dissolution rate, which is applied in the direction of testing pharmaceutical preparations, material analysis through observation of the influence on chemical indicators, and measuring devices, which can solve the problem of low repeatability and accuracy of determination methods and inability to measure accurately Solve the problems of bismuth pectin dissolution rate and low recovery rate of dissolution rate, and achieve the effect of improving controllability, good dissolution curve and dissolution rate, and high recovery rate

Active Publication Date: 2015-09-09
SHANXI ZHENDONG ANXIN BIOLOGICAL PHARM CO LTD
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Problems solved by technology

[0007] However, the colloidal bismuth pectin formed by the chelation of pectin and metal bismuth is very stable, and the viscosity of the colloid is relatively high. After being dissolved in the dissolution medium, it is a colloidal dispersion system. Bismuth content determination method combined with appendix The dissolution method of C is used to measure the dissolution rate. On the one hand, the consumption of titration liquid is very small, and the formed colloidal dispersion system has a great influence on the judgment of the titration end point of the complexometric titration method, resulting in low repeatability and accuracy of the assay method. Since the specification of the microporous membrane used to filter the dissolution solution is generally 200nm to 1μm, the recovery rate of the dissolution test will be low
Therefore it is impossible to accurately measure the dissolution rate of bismuth pectin in colloidal bismuth pectin preparations, and the method needs to be corrected

Method used

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  • Method for detecting dissolution rate of colloidal bismuth pectin preparation
  • Method for detecting dissolution rate of colloidal bismuth pectin preparation

Examples

Experimental program
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Effect test

Embodiment 1

[0028] Example 1: Colloidal pectin bismuth dispersible tablets (specification 50 mg, calculated as bismuth).

[0029] 1) Preparation of chromogenic solution: Take 5g of ascorbic acid and 25g of potassium iodide, put them in a 200ml volumetric flask, add 100ml of water, shake to dissolve, add 25ml of 1mol / L nitric acid solution, dilute with water and set the volume to the mark to make 2.5% ascorbic acid , Potassium iodide 12.5% ​​chromogenic solution.

[0030] 2) Preparation of bismuth reference substance solution: Take 275 mg of bismuth metal, accurately weigh it, put it in a 100 ml volumetric flask, add 6.4 ml of nitric acid to dissolve, dilute with water to the mark, and use it as a bismuth standard stock solution. Precisely measure 2ml of bismuth standard stock solution, put it in a 100ml volumetric flask, dilute to the mark with 1mol / L nitric acid solution, and make a solution containing 55μg of bismuth per 1ml, as the bismuth standard solution. Precisely measure 5ml of b...

Embodiment 2

[0035] Example 2: Colloidal pectin bismuth enteric-coated tablets (specification 100 mg, calculated as bismuth).

[0036] 1) Preparation of chromogenic solution: Take 15g of citric acid and 50g of potassium iodide, put them in a 200ml volumetric flask, add 100ml of water, shake to dissolve, add 25ml of 2mol / L nitric acid solution, dilute with water and set the volume to the mark to make Chromogenic solution of 7.5% acid and 25% potassium iodide.

[0037] 2) Preparation of bismuth reference substance solution: Take 275 mg of bismuth metal, accurately weigh it, put it in a 100 ml volumetric flask, add 6.4 ml of nitric acid to dissolve, dilute with water to the mark, and use it as a bismuth standard stock solution. Take 2ml of bismuth standard stock solution, put it in a 50ml volumetric flask, add 1.2mol / L nitric acid solution to dilute to the mark, and make a solution containing 110μg of bismuth per 1ml, as the bismuth standard solution. Precisely measure 5ml of bismuth standar...

Embodiment 3

[0042] Embodiment 3: colloidal bismuth pectin capsules (specification 50 mg, calculated as bismuth).

[0043] 1) Preparation of chromogenic solution: Take 1g of citric acid and 5g of potassium iodide, put them in a 200ml volumetric flask, add 100ml of water, shake to dissolve, add 25ml of 10mol / L nitric acid solution, dilute with water and set the volume to the mark to make lemon Chromogenic solution of 0.5% acid and 2.5% potassium iodide.

[0044] 2) Preparation of bismuth reference substance solution: Take 275 mg of bismuth metal, accurately weigh it, put it in a 100 ml volumetric flask, add 6.4 ml of nitric acid to dissolve, dilute with water to the mark, and use it as a bismuth standard stock solution. Take 1ml of bismuth standard stock solution, put it in a 100ml volumetric flask, add 1.1mol / L hydrochloric acid solution to dilute to the mark, and make a solution containing 27.5μg of bismuth per 1ml, as the bismuth standard solution. Precisely measure 1ml of bismuth stand...

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Abstract

The invention discloses a method for detecting dissolution rate of a colloidal bismuth pectin preparation. The method comprises the following steps of dissolving the colloidal bismuth pectin preparation in dissolution media by using the Ch. p 2010(2) Appendix XC of a Chinese Pharmacopoeia dissolution rate measuring method; directly taking digested liquor; adding proton acid dissociation agents in the digested liquor until the hydrogen ion concentration in the digested liquor is 0.8-1.2 mol / L; performing centrifugal separation to obtain liquid supernatant; adding citric acid or ascorbic acid and chromophoric solution of potassium iodide in the liquid supernatant to perform developing; and measuring and calculating the digested amount of colloidal bismuth pectin in bismuth by using a spectrophotometric method. By the method for detecting the dissolution rate of the colloidal bismuth pectin preparation, the dissolution curve and the dissolution rate of colloidal bismuth pectin in the colloidal bismuth pectin preparation can be measured well, and requirements on quality control are met.

Description

technical field [0001] The invention relates to a method for measuring the dissolution rate, in particular to a method for measuring the dissolution rate of colloidal pectin bismuth in a preparation containing colloidal pectin bismuth. Background technique [0002] Colloidal bismuth pectin is a compound of indeterminate composition formed by pectin and metal bismuth (Bi), yellow powder, containing 14.0%-16.0% pectin bismuth (calculated as bismuth), pH value 8.5-10.5, sedimentation Volume ratio 1-0.97, insoluble in organic solvents such as ethanol, acetone, ether, etc., can form a stable colloidal dispersion in water. [0003] Colloidal bismuth pectin replaces small molecular acid radicals with biomacromolecular pectin. Compared with other bismuth preparations such as bismuth subgallate, bismuth subnitrate, bismuth salicylate, and bismuth potassium citrate, the colloidal properties are stronger, The higher the viscosity, the less absorbed by the body. Colloidal bismuth pect...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/78G01N21/33
CPCG01N21/33G01N13/00G01N2013/006G01N33/15G01N21/78G01N15/06G01N2015/0693
Inventor 李安平崔锋朱平秦正国郑台吴月侠
Owner SHANXI ZHENDONG ANXIN BIOLOGICAL PHARM CO LTD
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