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Determination of free bismuth in colloidal bismuth pectin or preparations containing colloidal bismuth pectin

A technology of colloidal bismuth pectin and a detection method, which is applied in the field of free bismuth detection, can solve problems such as the inability to distinguish macromolecular colloidal bismuth pectin from free bismuth, and achieve high accuracy, strong specificity, and good repeatability Effect

Active Publication Date: 2022-01-21
SHANXI ZHENDONG ANXIN BIOLOGICAL PHARM CO LTD
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Problems solved by technology

[0012] However, the final colloidal bismuth pectin or the bismuth content in the colloidal pectin-containing bismuth preparation also contains free bismuth content, and it is still impossible to distinguish macromolecular colloidal bismuth pectin from free bismuth

Method used

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  • Determination of free bismuth in colloidal bismuth pectin or preparations containing colloidal bismuth pectin
  • Determination of free bismuth in colloidal bismuth pectin or preparations containing colloidal bismuth pectin
  • Determination of free bismuth in colloidal bismuth pectin or preparations containing colloidal bismuth pectin

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Experimental program
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Embodiment 1

[0037] Embodiment 1: Determination of free bismuth content in colloidal pectin bismuth bulk drug.

[0038] 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.

[0039] 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 about 55μg of bismuth per 1ml, as the bismuth standard solution. Precisely measure 5ml of bismut...

Embodiment 2

[0043] Embodiment 2: Determination of free bismuth content in colloidal pectin bismuth capsules (specification 40 mg, calculated as bismuth).

[0044] 1) Preparation of chromogenic solution: Take 2.5g 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 make ascorbic acid-containing solution 1.25%, potassium iodide 6.25% color solution.

[0045] 2) Preparation of bismuth reference solution: Take 255 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, dilute to the mark with 0.8mol / L nitric acid solution, and make a solution containing about 51μg of bismuth per 1ml, as the bismuth...

Embodiment 3

[0049] Embodiment 3: Determination of free bismuth content in colloidal pectin bismuth capsules (specification 50 mg, calculated as bismuth).

[0050] 1) Preparation of chromogenic solution: Take 10g 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 nitric acid solution, dilute with water and set the volume to the mark to make 5% ascorbic acid , Potassium iodide 25% chromogenic solution.

[0051] 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 1ml 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 about 27.5μg of bismuth per 1ml, as the bismuth standard s...

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Abstract

The invention provides a method for detecting free bismuth in colloidal bismuth pectin or colloidal pectin-containing bismuth preparations. The colloidal pectin bismuth or colloidal pectin-containing bismuth preparations are placed in a plastic centrifuge tube, and water is added for no more than 1 minute. Shake to obtain a uniformly dissolved colloidal solution, centrifuge the colloidal solution immediately, separate the supernatant, detect the bismuth content in the supernatant by complexometric titration or ultraviolet spectrophotometry, and calculate the colloidal bismuth pectin Or the content of free bismuth in bismuth preparations containing colloidal pectin. The detection method of colloidal bismuth pectin or free bismuth in colloidal pectin-containing bismuth preparations established by the present invention has strong specificity, high accuracy, good repeatability, good linear relationship and high sensitivity, and can be used as colloidal pectin bismuth or colloidal pectin-containing bismuth. The quality control method of free bismuth in colloidal bismuth preparation, to effectively control the product quality of colloidal bismuth pectin and preparation thereof.

Description

technical field [0001] The invention belongs to the technical field of colloidal pectin bismuth quality control and relates to a method for detecting free bismuth in colloidal pectin bismuth or colloidal pectin bismuth-containing preparations. 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 included in the second volume of the 2015 edition of the "Chinese Pharmacop...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N21/33G01N21/78G01N31/16
CPCG01N21/33G01N21/78G01N31/16
Inventor 李安平崔锋朱平秦正国姚利娜白洁张禄
Owner SHANXI ZHENDONG ANXIN BIOLOGICAL PHARM CO LTD
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