Dispersion preparation containing colloidal bismuth pectin and preparation method thereof

A technology of colloidal bismuth pectin and preparations, which is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, and pill delivery, etc., can solve the problems such as dispersible tablets no longer meet the requirements, and shorten the disintegration time limit. , the effect of speeding up and reducing the amount of use

Active Publication Date: 2014-11-19
SHANXI ZHENDONG ANXIN BIOLOGICAL PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the above regulations, the dispersible tablet may no longer meet the requirements

Method used

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  • Dispersion preparation containing colloidal bismuth pectin and preparation method thereof
  • Dispersion preparation containing colloidal bismuth pectin and preparation method thereof
  • Dispersion preparation containing colloidal bismuth pectin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Prescription: 324.7g colloidal bismuth pectin, 25.0g low-substituted hydroxypropyl cellulose, 80.8g microcrystalline cellulose, 15.0g calcium sulfate dihydrate, 27.5g citric acid monohydrate, 22.0g sodium bicarbonate, 5.0g talc powder , 50% ethanol 300ml. Made into 1000 tablets, each weighing 500mg.

[0051] Preparation process: crush the raw and auxiliary materials and pass through a 100-mesh sieve. Weigh the prescription amount of colloidal bismuth pectin, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, calcium sulfate dihydrate, and sodium bicarbonate and mix evenly; add the prescription amount of 50% ethanol-made soft material, pass through a 24-mesh sieve to granulate , baked at 60°C for 2 hours, sieved with a 24-mesh sieve, added citric acid monohydrate and talcum powder, and mixed evenly; determined drug content, pressed into tablets, coated with film, tested, and packaged.

[0052] Test indicators: hardness 3.0±0.5kg, dispersion uniformity...

Embodiment 2

[0054] Prescription: 324.7g colloidal bismuth pectin, 26.5g low-substituted hydroxypropyl cellulose, 98.0g microcrystalline cellulose, 15.9g calcium sulfate dihydrate, 33.1g anhydrous citric acid, 26.5g sodium bicarbonate, 5.3g talcum powder . Made into 1000 tablets, each weighing 530mg.

[0055] Preparation process: crush the raw and auxiliary materials and pass through a 100-mesh sieve. Weigh the prescribed amount of colloidal bismuth pectin, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, calcium sulfate dihydrate, sodium bicarbonate, anhydrous citric acid, and talcum powder, mix evenly, determine the drug content, compress tablets, and test ,Package.

[0056] Test indicators: hardness 3.0±0.5kg, dispersion uniformity 102s, dissolution rate 81.64%, colloidal stability and weight difference meet the requirements.

Embodiment 3～9

[0058]

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PUM

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Abstract

The invention discloses a dispersion preparation containing colloidal bismuth pectin and a preparation method thereof. 1 g is used as a unit for the dispersion preparation; in each unit of the preparation, colloidal bismuth pectin or a drug containing colloidal bismuth pectin, in terms of colloidal bismuth pectin, is 44.0 to 900.0 mg, and each unit further contains 1.0 to 500 mg of a penetration enhancer, 2.0 to 312.5 mg of an acid-source pore forming agent, 2.0 to 250.0 mg of an alkali-source pore forming agent and 1.0 to 400.0 mg of a disintegrating agent. The dispersion preparation containing colloidal bismuth pectin has a dissolution rate of more than 80%, satisfactory colloidal stability and dispersion uniformity of less than 2.5 min, so regulations for dispersion uniformity are met, effective dissolution is realized, and the characteristic of colloidal stability of colloidal bismuth pectin is realized.

Description

technical field [0001] The invention relates to a stomach medicine preparation, in particular to a stomach medicine dispersion preparation and a preparation method of the dispersion preparation. Background technique [0002] Colloidal bismuth pectin is a kind of colloidal bismuth formed by pectin, a biomacromolecule substance, and metal bismuth. Bismuth can kill Helicobacter pylori, improve the healing rate of peptic ulcer, and reduce its recurrence rate. Colloidal bismuth pectin has good colloidal properties in acidic media, and can form a gel in gastric juice to protect gastric mucosa. Observation under gastroscope, colloidal bismuth pectin deposits significantly more on the surface of ulcers and bleeding mucosa. From this point of view, colloidal bismuth pectin has good selective adhesion, which can prolong the retention time of drugs in the stomach and improve the efficacy of antibiotics and other drugs. Concentration in ulcers and inflammatory tissues is conducive to t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/732A61K47/02A61K47/12A61K9/20A61K9/28A61P1/04
CPCA61K31/732A61K9/2013A61K9/2054A61K9/10A61K9/2009A61K9/2095A61K33/245A61P1/04
Inventor 李安平沈琦朱平秦正国吴月侠李静
Owner SHANXI ZHENDONG ANXIN BIOLOGICAL PHARM CO LTD
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