A kind of quality control of colloidal bismuth pectin pharmaceutical composition and its galacturonic acid content determination method

A quality control method, the technology of colloidal bismuth pectin, applied in the field of determination of galacturonic acid content, can solve the problems that the curative effect of colloidal bismuth pectin cannot be further improved, the quality control is not rigorous enough, and the product controllability is poor. The standard is scientific, reasonable and controllable, the effect of enhancing the dehydration effect and reducing the drying time

Active Publication Date: 2018-07-17
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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  • A kind of quality control of colloidal bismuth pectin pharmaceutical composition and its galacturonic acid content determination method
  • A kind of quality control of colloidal bismuth pectin pharmaceutical composition and its galacturonic acid content determination method
  • A kind of quality control of colloidal bismuth pectin pharmaceutical composition and its galacturonic acid content determination method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0036] 1. Preparation of colloidal bismuth pectin:

[0037] (1) Add 166.67g purified water to 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 the hydrolysis complete (that is, the retest pH is constant) Then, filter to obtain the filter cake bismuth hydroxide; then put 40.56g of purified water and 17.89g of sorbitol into the beaker. After the sorbitol is dissolved, add the filter cake bismuth hydroxide, stir and add 40% potassium hydroxide About 50g of the solution, stir to make it fully dissolved, and get the bismuth salt solution for later use;

[0038] (2) In step (1), add the bismuth salt solution prepared in step (1) to the reaction flask, stir, add 49ml of purified water, add pectin soft material at room temperature, after the addition, heat up to about 40 ℃ and stir, and heat for 0.5 hours. Then add 105g of purified water, control the temperature at 30-35℃ and stir for 1.5 hours; when th...

Embodiment 2

[0040] Example 2. Preparation of colloidal bismuth pectin dry suspension

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

[0042] Mannitol 455g

[0043] Disodium hydrogen phosphate 15g

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

[0045] Production method: 1) Weigh the ingredients 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 total mixer in turn Mix, the mixing time is 30 minutes, the speed of the total mixer is 50Hz; 3) After mixing, sample the product (sampling volume is about 30g) for testing. After passing the test, divide it into 1000 bags, vacuum seal, label, store, Packaging and storage.

Embodiment 3

[0046] Example 3 Preparation of colloidal bismuth pectin dry suspension

[0047] Prescription: colloidal pectin bismuth 900kg

[0048] Mannitol 409.5kg

[0049] Disodium hydrogen phosphate 13.5kg

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

[0051] Production method: 1) Weigh the ingredients 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 total mixer in turn Mix, the mixing time is 30 minutes, and the speed of the total mixer is 50Hz; 3) After mixing, sample the product (sampling volume is about 30g) for testing. After passing the test, divide it into 900,000 bags, vacuum seal, label, and store ,Packaging and storage.

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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 method for quality control 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 a compound of indeterminate composition formed by pectin and bismuth. As a raw material, it belongs to the gastric mucosal protective drug. It is characterized in that its molecule is composed of D-galacturonic acid methyl ester and D-galacturonaldehyde. The high molecular compound formed by the structural fragments of bismuth acid and potassium D-galacturonate and the new bismuth salt compound formed by the acid radical of biological macromolecule. [0003] Colloidal pectin bismuth compound, with high selective adhesion, the strength of this adhesive adhesion is proportional to the protective effect on the injured gastrointestinal mucosa and the killing of Helicobacter Pylori (HP)...

Claims

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Application Information

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Patent Type & Authority Patents(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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