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Hydroxy-aluminum montmorillonite chewable tablet as well as preparation method and application thereof

A hydroxyaluminum montmorillonite, chewable tablet technology, applied in the directions of aluminum/calcium/magnesium active ingredients, digestive system, pill delivery, etc. , relieve stomach pain, promote gastric ulcer healing effect

Active Publication Date: 2015-11-18
SHANDONG SBOND PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Since montmorillonite is a crystalline hydrated magnesium aluminum silicate mineral, the particle size of montmorillonite is extremely small in nature, the particle size is within 2 μm, and its surface energy is relatively large, so it generally aggregates into larger particles. Other minerals The particle size of impurities is mainly distributed > 2 μm, and they are agglomerated with montmorillonite. Since montmorillonite has a Mohs hardness of 2 to 2.5, and other mineral impurities have relatively large Mohs hardness, it is necessary to prepare it by direct tableting. tablet, it is easy to cause wear and tear of the tablet press, and it is easy to produce tablet compression spots
In addition, since montmorillonite is a clay mineral, its material is relatively viscous. During the granulation process, it is necessary to strictly control the amount of binder added to prevent the material from becoming sticky during the tableting process and affecting the disintegration of the tablet. Prolonged solution time and exerted clinical curative effect

Method used

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  • Hydroxy-aluminum montmorillonite chewable tablet as well as preparation method and application thereof
  • Hydroxy-aluminum montmorillonite chewable tablet as well as preparation method and application thereof
  • Hydroxy-aluminum montmorillonite chewable tablet as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0038] A preparation method of hydroxyaluminum montmorillonite chewable tablet, comprising the steps of:

[0039] (1) Pulverize the hydroxyaluminum montmorillonite, pass through a 90-110 mesh sieve, and then use laser particle size measurement to obtain an average particle size of 8-27 μm;

[0040] (2) adding 95% (W / W) medicinal ethanol to purified water to prepare 75-80% (W / W) ethanol / water solution for later use;

[0041] (3) Add polyethylene glycol 6000 into the 75-80% (W / W) ethanol / water solution prepared in step (2), heat up to 60-65°C, continue to stir for 0.5-1h, and set aside;

[0042] (4) Take the hydroxyaluminum montmorillonite of step (1) and add it in step (3), carry out ultrasonic treatment, the ultrasonic frequency is 30~45KHz, continue to stir for 0.5~1.5h, granulate, fluidized bed drying, temperature is 50 ~60℃; crushed, passed through 90~110 mesh sieve, and set aside;

[0043] (5) Crushing the sucrose, passing through a 80-100 mesh sieve, and processing the ...

experiment example 1

[0060] Experimental Example 1: Determination of particle size and particle size distribution of hydroxyaluminum montmorillonite

[0061] Hydroxy aluminum montmorillonite is prepared by modifying montmorillonite, and montmorillonite is a kind of mineral medicine, which is a kind of hydrous layered silicate mineral. Regardless of the amount of active ingredient in the chewable tablet, it will leave an uncomfortable gritty feeling in the mouth, so the hydroxyaluminum montmorillonite is selected and ultrafinely pulverized.

[0062] The particle size distribution of hydroxyaluminum montmorillonite was determined using sieve analysis. 50g of hydroxyaluminum montmorillonite particles are tested for each batch. Use a sieve meter and a standard test sieve to measure, the amplitude is 1.5mm, and the vibration time is 20min. The specifications of the sieve are 60 mesh, 70 mesh, 80 mesh, 90 mesh, 100 mesh and 110 mesh. A laser diffraction particle size analyzer purchased from Marlven20...

experiment example 2

[0071] Experimental example 2: Research experiment on the pretreatment of hydroxyaluminum montmorillonite

[0072] 1. Experimental research on the preparation of chewable tablets with various specifications of polyethylene glycol

[0073] During the tableting process, the hydroxyaluminum montmorillonite is prone to sticking due to electrostatic adsorption and other effects, making the tablet production impossible; the present invention uses polyethylene glycol as an auxiliary material to pretreat the hydroxyaluminum montmorillonite , so as to fundamentally solve the problem of sticking and punching, wherein the mass ratio of hydroxyaluminum montmorillonite to polyethylene glycol is: 1. hydroxyaluminum montmorillonite: polyethylene glycol 400 = 55: 7; 2. hydroxyaluminum montmorillonite Stone: polyethylene glycol 1000 = 55: 7; 3, hydroxyaluminum montmorillonite: polyethylene glycol 1500 = 55: 7; 4, hydroxyaluminum montmorillonite: polyethylene glycol 2000 = 55: 7; 5, Hydroxy al...

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Abstract

The invention discloses a hydroxy-aluminum montmorillonite chewable tablet as well as a preparation method and application thereof. The hydroxy-aluminum montmorillonite chewable tablet disclosed by the invention is characterized in that hydroxy-aluminum montmorillonite is taken as an effective component of a medicament; the mass percentage of the hydroxy-aluminum montmorillonite in the chewable tablet is 50 to 80 percent; proper pharmaceutic adjuvants are added into the hydroxy-aluminum montmorillonite to prepare a chewable tablet medicament. By administrating the chewable tablet through a gastrointestinal tract, the effective component of the hydroxy-aluminum montmorillonite chewable tablet can be used for neutralizing a pH value of gastric juice of a patient and further reducing the activity of pepsase, so that the actions of alleviating gastralgia and promoting gastric ulcer healing can be realized; then, the hydroxy-aluminum montmorillonite is discharged outside through a digestive tract, so that the aim of resisting gastric acid is achieved; the hydroxy-aluminum montmorillonite chewable tablet disclosed by the invention is higher in dissolution rate and good in clinical curative effect.

Description

technical field [0001] The present invention relates to hydroxyaluminum montmorillonite chewable tablets and a method for preparing the same, and further relates to the use of hydroxyaluminum montmorillonite chewable tablets in the preparation of medicines for treating conditions or diseases associated with harmful gastric acid levels, such as peptic ulcer, dyspepsia, Heartburn, acid indigestion, or acid reflux. Background technique [0002] Gastrointestinal drugs are generally used to relieve clinical symptoms such as hyperacidity, stomach discomfort, bloating, and indigestion. Gastrointestinal diseases such as gastric ulcer, duodenal ulcer, and gastritis caused by excessive gastric acid secretion are the most common. frequently-occurring disease. Among anti-peptic ulcer drugs, antacids are used early. The curative effect is similar to receptor antagonists, and it is still the main category of anti-ulcer drugs, with a large amount of clinical use. Due to the important ro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K33/06A61P1/04A61P1/14
Inventor 乔敏袁靖尧袁洲杰袁武杰
Owner SHANDONG SBOND PHARMA
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