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Quality control method of colloidal bismuth pectin pharmaceutical composition

A quality control method and colloidal bismuth pectin technology are applied in the field of improving the quality of a colloidal bismuth pectin pharmaceutical composition, which can solve the problems of poor product controllability, research, inability to further improve the curative effect of colloidal bismuth pectin, and the like. Safety, avoiding toxic and side effects, improving drug stability and efficacy

Active Publication Date: 2016-05-11
HUNAN WARRANT PHARMA +1
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The Chinese patent with application number 201110300984.1 proposes a quality detection method for colloidal bismuth pectin pharmaceutical composition. In view of the existing quality control methods for colloidal bismuth pectin and its pharmaceutical preparations, the quality control of indicators related to curative effect is not strict enough, resulting in The problem of poor controllability of products with poor curative effect
The measurement items and indicators of intrinsic viscosity, uniformity, and galacturonic acid content have been added to effectively ensure the clinical efficacy of the product, but no more detailed research has been done on each technical parameter, so that those skilled in the art cannot go further Improve the curative effect of colloidal bismuth pectin

Method used

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  • Quality control method of colloidal bismuth pectin pharmaceutical composition
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  • Quality control method of colloidal bismuth pectin pharmaceutical composition

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Experimental program
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Embodiment

[0044] 1. Preparation of colloidal bismuth pectin

[0045] (1) Add 166.67g of purified water into the reaction flask, add 29.22g of bismuth nitrate; add about 23.78g of 40% potassium hydroxide solution, adjust the pH to 6-8, and make it hydrolyze completely (that is, retest the pH to be constant) Finally, filter to get the filter cake bismuth hydroxide; then put 40.56g of purified water and 17.89g of sorbitol into the beaker, and then add the filter cake bismuth hydroxide after the sorbitol dissolves, and add 40% potassium hydroxide after stirring About 50g of the solution, stir to make it fully dissolve, and obtain the bismuth salt solution for later use;

[0046] In (2), add the bismuth salt solution prepared in step (1) into the reaction flask, stir, add 49ml of purified water, add pectin soft material at room temperature, after the addition is completed, heat up to about 40°C and stir, keep the temperature for 0.5 hours, and then Add 105g of purified water, control the te...

experiment example

[0074] 1. Determination of content uniformity of colloidal bismuth pectin pharmaceutical composition

[0075] In the present invention, the content uniformity is according to the Chinese Pharmacopoeia 2010 edition two appendix XE content uniformity method: research and detect with reference to the method under the content determination item.

[0076] Assay method is: get 3 batches of colloidal pectin bismuth dry suspension product prepared according to the embodiment of the present invention 2, each 10 groups, respectively put in the conical flask of 500ml, add nitric acid solution 10ml, concentrated nitric acid and water in the nitric acid solution The volume ratio is 1:2, heat to dissolve, add 300ml of water and 4 drops of xylenol orange indicator solution, and titrate with disodium edetate titration solution (0.05mol / L) until the solution turns yellow. Every 1ml of disodium edetate titration solution (0.05mol / L) is equivalent to 10.45mg of bismuth (Bi). The results are sho...

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Abstract

The invention relates to a quality control method of a colloidal bismuth pectin pharmaceutical composition. The pharmaceutical composition is made into dry suspension and is made of the following components in parts by weight: 130 to 160 parts of bulk drug namely bismuth pectin (calculated by bismuth), 420 to 460 parts of filling agent namely mannitol, and 10 to 20 parts of flocculating agent namely disodium hydrogen phosphate and / or flavoring agent. The galacturonic acid transfer rate of the pharmaceutical composition is 96 to 102%. The content of galacturonic acid is not less than 0.4 gram for each 1.46 grams of dry suspension of colloidal bismuth pectin. The intrinsic viscosity number is not less than 1000; the bismuth ion content and uniformity of the pharmaceutical composition are controlled to improve the stability and treatment effect of dry suspension of colloidal bismuth pectin. The technology advancement of pharmaceutical industry is promoted, and the industry of quality control of colloidal bismuth pectin drugs is promoted.

Description

[0001] Technical field: the present invention relates to a kind of method that improves the quality of colloidal bismuth pectin pharmaceutical composition. Background technique [0002] Colloidal bismuth pectin is an indeterminate compound produced by pectin and bismuth. As a raw material drug, it belongs to gastric mucosal protective drugs. It is characterized in that its molecules are composed of D-galacturonate methyl ester, D-galacturonaldehyde Bismuth bismuth acid and potassium D-galacturonate structural fragments formed polymer compounds and new bismuth salt compounds formed by acid radicals of biomacromolecules. [0003] Since the colloidal bismuth pectin pharmaceutical composition can form a stable colloidal dispersion in water and form a gel in artificial gastric juice, it has strong colloidal properties and has a strong affinity with the ulcer surface, promoting the healing of ulcers and the disappearance of inflammation , can also stimulate mucosal epithelial cells ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/78G01N31/16A61K9/14A61K31/732A61P1/04
CPCA61K9/14A61K31/732G01N21/78G01N31/16
Inventor 肖爱平周志刚刘海艳覃琳
Owner HUNAN WARRANT PHARMA
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