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Method for controlling quality of colloidal bismuth pectin medicine composition and measuring galacturonic acid content of colloidal bismuth pectin medicine composition

A quality control method and technology of colloidal bismuth pectin, which are applied in the field of determination of galacturonic acid content, can solve the problems such as the inability to further improve the curative effect of colloidal bismuth pectin, the quality control is not strict enough, the product controllability is poor, etc. The standard is scientific, reasonable and controllable, the effect of enhancing the dehydration effect and reducing the drying time

Active Publication Date: 2016-04-06
HUNAN WARRANT PHARMA +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] 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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  • Method for controlling quality of colloidal bismuth pectin medicine composition and measuring galacturonic acid content of colloidal bismuth pectin medicine composition
  • Method for controlling quality of colloidal bismuth pectin medicine composition and measuring galacturonic acid content of colloidal bismuth pectin medicine composition
  • Method for controlling quality of colloidal bismuth pectin medicine composition and measuring galacturonic acid content of colloidal bismuth pectin medicine composition

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Experimental program
Comparison scheme
Effect test

Embodiment

[0036] 1. Preparation of colloidal bismuth pectin:

[0037] (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;

[0038] In (2), add the bismuth salt solution prepared in step (1) into the reaction bottle, 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, and keep the temperature for 0.5 hours. Then add 105g of purified water, control the ...

Embodiment 2

[0040] Embodiment 2, the preparation of colloidal bismuth pectin dry suspension

[0041] Prescription: colloidal bismuth pectin 1000 (based on 150g bismuth)

[0042] Mannitol 455g

[0043] Disodium hydrogen phosphate 15g

[0044] Specification: 150mg (calculated as bismuth)

[0045]Production method: 1) Weigh the raw and auxiliary materials in the prescription on an electronic scale according to the ratio in the prescription; 2) Put the weighed colloidal bismuth pectin, disodium hydrogen phosphate and mannitol into the mixing machine in sequence Mixing, the mixing time is 30 minutes, and the speed of the total mixer is 50Hz; 3) After mixing, the product is sampled (about 30g) for detection, and after passing the test, it is divided into 1000 bags, vacuum-sealed, labeled, stored, wrap up and store.

Embodiment 3

[0046] The preparation of embodiment 3 colloidal bismuth pectin dry suspension

[0047] Prescription: colloidal bismuth pectin 900kg

[0048] Mannitol 409.5kg

[0049] Disodium hydrogen phosphate 13.5kg

[0050] Specification: 150mg (calculated as bismuth)

[0051] Production method: 1) Weigh the raw and auxiliary materials in the prescription on an electronic scale according to the ratio in the prescription; 2) Put the weighed colloidal bismuth pectin, disodium hydrogen phosphate and mannitol into the mixing machine in sequence Mixing, the mixing time is 30 minutes, and the speed of the total mixer is 50Hz; 3) After mixing, the product is sampled (about 30g) for detection, and after passing the test, it is divided into 900,000 bags, vacuum-sealed, labeled, and stored ,wrap up and store.

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Abstract

The invention relates to a method for controlling quality of a colloidal bismuth pectin medicine composition and measuring the galacturonic acid content of the colloidal bismuth pectin medicine composition. The medicine composition is a dry suspension and is prepared from, by weight, 130-160 parts of raw material colloidal bismuth pectin (by bismuth), 420-460 parts of filling agent mannitol and 10-20 parts of flocculant disodium hydrogen phosphate and / or corrigent. The galacturonic acid content of the medicine composition is controlled, medicine stability and the treatment effect of the colloidal bismuth pectin dry suspension are improved, great influences are generated on technological progress of the medicine composition and the pharmaceutical industry, and obvious scientific progress and promotion functions are generated in the field of colloidal bismuth pectin quality control.

Description

technical field [0001] The invention relates to a quality control method of a colloidal bismuth pectin pharmaceutical composition, and also relates to a method for determining the content of galacturonic acid in the 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] Colloidal bismuth pectin compound has high selective adhesion, and the strength of this adhesive adhesion is directly proportional to the protective effect of the damaged gastrointestinal mucosa and the effect of killing Helicobacter pylori (HelicobacterPylori, HP)...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N31/16G01N21/79
CPCG01N21/79G01N31/164
Inventor 周志刚覃琳刘海艳肖爱平
Owner HUNAN WARRANT PHARMA
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