Method for measuring free bismuth in colloidal bismuth pectin or preparation containing colloidal bismuth pectin

A colloidal pectin bismuth and preparation technology, applied in the field of free bismuth determination, can solve problems such as difficulty and poor reproducibility of measurement results, and achieve the effect of simple method, easy operation and strong specificity

Active Publication Date: 2019-08-20
SHANXI ZHENDONG ANTE BIOPHARMACEUTICAL CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

This undoubtedly brings a certain degree of difficulty to the experimental operation, and since the shaking time and centrifugation time of each experiment cannot be completely consistent, it will inevitably lead to poor reproducibility of the measurement results.

Method used

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  • Method for measuring free bismuth in colloidal bismuth pectin or preparation containing colloidal bismuth pectin
  • Method for measuring free bismuth in colloidal bismuth pectin or preparation containing colloidal bismuth pectin
  • Method for measuring free bismuth in colloidal bismuth pectin or preparation containing colloidal bismuth pectin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Embodiment 1: Determination of free bismuth content in colloidal pectin bismuth bulk drug.

[0045] 1) Preparation of chromogenic solution: Take about 2.5g of ascorbic acid and about 12.5g of potassium iodide, put them in a 200ml volumetric flask, add about 100ml of water, shake to dissolve, add 25ml of 1mol / L nitric acid solution, dilute with water and set the volume to the mark, Prepare a solution containing 1.25% ascorbic acid and 6.25% potassium iodide.

[0046] 2) Preparation of bismuth reference solution: Take about 250 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 to the mark with water, and use it as a bismuth standard stock solution. Precisely measure 1ml of bismuth standard stock solution, put it in a 50ml volumetric flask, add 1mol / L nitric acid solution to dilute to the mark, and make a solution containing about 50μg of bismuth per 1ml, as the bismuth standard solution. Precisely...

Embodiment 2

[0051] Embodiment 2: Determination of free bismuth content in colloidal pectin bismuth capsules (specification 40 mg, calculated as bismuth).

[0052] 1) Preparation of chromogenic solution: Take 5g of ascorbic acid and 12.5g 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 prepare ascorbic acid 2.5 %, potassium iodide 6.25% chromogenic solution.

[0053] 2) Preparation of bismuth reference substance solution: Take about 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 to the mark with water, and use it as a bismuth standard stock solution. Precisely measure 2ml of bismuth standard stock solution, put it in a 100ml volumetric flask, add 0.8mol / L nitric acid solution to dilute to the mark, and make a solution containing about 55μg of bismuth per 1ml, as the bi...

Embodiment 3

[0057] Embodiment 3: Determination of free bismuth content in colloidal pectin bismuth capsules (specification 50 mg, calculated as bismuth).

[0058] 1) Preparation of chromogenic solution: Take 20g of ascorbic acid and 50g of potassium iodide, put them in a 200ml volumetric flask, add 100ml of water, shake to dissolve, add 25ml of 1mol / L acetic acid solution, dilute with water and set the volume to the mark to make 10% ascorbic acid , Potassium iodide 25% chromogenic solution.

[0059] 2) Preparation of bismuth reference substance solution: Take about 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 to the mark with water, and use it as a bismuth standard stock solution. Precisely measure 1ml of bismuth standard stock solution, put it in a 100ml volumetric flask, add 1mol / L nitric acid solution to dilute to the mark, and make a solution containing about 27.5μg of bismuth per 1ml, as the bismuth s...

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Abstract

The invention provides a method for measuring free bismuth in colloidal bismuth pectin or a preparation containing colloidal bismuth pectin. The method comprises the following steps of: adding ethanolwater solution with the volume concentration of 7-20% into the colloidal bismuth pectin or the preparation containing the colloidal bismuth pectin, and shaking to enable the dissolution to be uniform, or adding ethanol water solution with the volume concentration not more than 5% to shake and disperse, then adding ethanol until the volume concentration of the ethanol in the dispersion liquid is 30-50%, and shaking to enable the dissolution to be uniform to obtain colloidal solution; centrifuging to obtain supernatant; measuring by a complexometric titration method or an ultraviolet spectrophotometry method; and calculating the content of free bismuth in the colloidal bismuth pectin or the preparation containing the colloidal bismuth pectin. The ethanol aqueous solution not only has bettersolubility to free bismuth, but also can seal colloidal bismuth pectin molecules to a certain extent, and effectively prevent the dynamic bismuth salt release process of the colloidal bismuth pectin.According to the invention, the free bismuth is measured by dispersing the colloidal bismuth pectin with the ethanol aqueous solution, and the measuring result of the free bismuth is more accurate and reliable.

Description

technical field [0001] The invention belongs to the technical field of colloidal bismuth pectin quality control, and relates to a method for determining free bismuth in colloidal bismuth pectin or preparations containing bismuth pectin, which is used to control the limit of free bismuth and improve drug safety. Background technique [0002] Colloidal bismuth pectin and its capsules are the first drugs produced by Taiyuan Hongxing Pharmaceutical Factory, the predecessor of Shanxi Zhendong Ante Biopharmaceutical Co., Ltd. The drug was first approved by the former Ministry of Health in July 1992 to be produced and launched by Taiyuan Hongxing Pharmaceutical Factory. [0003] The active ingredient of colloidal bismuth pectin capsules is yellow powder, which is insoluble in organic solvents such as ethanol, acetone, ether, etc. It can form a stable colloidal dispersion in water and form a gel in artificial gastric juice. Colloidal bismuth pectin and its capsules have been includ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/79G01N21/33
CPCG01N21/33G01N21/79G01N21/31G01N31/00
Inventor 李安平白洁朱平姚利娜李昆崔锋秦正国
Owner SHANXI ZHENDONG ANTE BIOPHARMACEUTICAL CO LTD
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