Hydroxy-aluminum montmorillonite suspension as well as preparation method and application thereof

A hydroxyaluminum montmorillonite, suspension technology, applied in liquid transportation, emulsion transportation, aluminum/calcium/magnesium active ingredients, etc. Stabilizer use effect and other issues to achieve the effect of promoting healing and relieving stomach pain

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

[0003] The liquid antacid composition disclosed in Chinese patent literature CN1179307 is a liquid antacid preparation composition containing a tri-ester or di-ester buffer (its pharmaceutical composition can be calcium carbonate, magnesium carbonate, magnesium silicate or H 2 receptor antagonists, etc.); the liquid antacid composition disclosed in Chinese patent document CN1203079 is an antacid composition that includes one or more calcium carbonate liquids that preferably keep the pH greater than 9.5; the above patents have the following problems, 1. There are many excipients selected, which affect the stability of the drug and the determination of drug content; 2. The antacid raw materials selected are basically water-insoluble, and the sedimentation volume ratio of the pharmaceutical composition is not stated to evaluate the sedimentation stability of the suspension Performance and the effect of stabilizer
[0005] In summary, the problems existing in the prior art of liquid antacid preparations are as follows: one is that there are many auxiliary materials selected, which affect the stability of the drug and the determination of drug content; Express the sedimentation volume ratio of the pharmaceutical composition, evaluate the sedimentation stability of the suspension and the use effect of the stabilizer; the third is to prepare the required suspension through the direct colloid milling method. Within, it is easy to produce unqualified sedimentation volume ratio

Method used

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  • Hydroxy-aluminum montmorillonite suspension as well as preparation method and application thereof
  • Hydroxy-aluminum montmorillonite suspension as well as preparation method and application thereof
  • Hydroxy-aluminum montmorillonite suspension 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 suspension, 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 purified water to step (1) to prepare a suspension solution with a mass ratio of hydroxyaluminum montmorillonite: purified water = 1: 5-10, for subsequent use;

[0041] (3) Use 0.1-0.3 mol / L sodium hydroxide solution to adjust the pH of the suspension solution in step (2) to 8.5-9.5 under stirring; continue stirring for 0.5-1 h, age for 24 h, and set aside;

[0042] (4) Ultrasonic treatment of step (3), the ultrasonic frequency is 30-45KHz, continue to stir for 0.5-1.5h, after standing for 2-3h, separate the upper layer of water after layering, then centrifuge, discard the filtrate, Repeatedly washing with water several times until the pH of the lotion reaches neutrality, and...

experiment example 1

[0059] Experimental example 1: Determination experiment of average particle size and particle size distribution of hydroxyaluminum montmorillonite

[0060] 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. No matter how much the active ingredient of the suspension occupies in the prescription, it will leave an uncomfortable gritty feeling in the mouth, so the hydroxyaluminum montmorillonite is selected and crushed.

[0061] 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. Use the laser diffraction particle size anal...

experiment example 2

[0070] Experimental example 2: Research experiment on the pretreatment of hydroxyaluminum montmorillonite with sodium hydroxide

[0071] The activation treatment re-associates the hydroxyaluminum montmorillonite particles, and the activator metal ion Na + The ions enter the crystal layer of the hydroxyaluminum montmorillonite, exchange reaction with the ions adsorbed on the edge of the hydroxyaluminum montmorillonite, and produce non-ionized substances, which fall off from the edge of the hydroxyaluminum montmorillonite, increase the charge of the colloidal particles, and eliminate or reduce the hydroxyl group. The negative charge of the aluminum montmorillonite edge, the thickness of the diffusion layer is large, and the expansion multiple is high. The cation can act as a similar chemical bond to link the hydroxyaluminum montmorillonite particles together, so that the hydroxyaluminum montmorillonite particles form a gel structure dominated by edge-to-edge association and resu...

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Abstract

The invention discloses a hydroxy-aluminum montmorillonite suspension as well as a preparation method and application thereof. The hydroxy-aluminum montmorillonite suspension 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 suspension is 5 to 15 percent; proper pharmaceutic adjuvants are added into the hydroxy-aluminum montmorillonite to prepare a suspension medicament. The effective component of the hydroxy-aluminum montmorillonite suspension 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.

Description

technical field [0001] The present invention relates to a suspension of hydroxyaluminum montmorillonite and a method for its preparation, which further relates to the use of said suspension of hydroxyaluminum montmorillonite in the preparation of antacid drugs for the treatment of conditions or diseases associated with harmful gastric acid levels, such as Peptic ulcer, indigestion, heartburn, acid indigestion, or acid reflux. Background technique [0002] Gastrointestinal diseases such as gastric ulcer, duodenal ulcer and gastritis caused by excessive gastric acid secretion are the most common frequently-occurring diseases. Antacids were applied early, and their efficacy is similar to that of H2 receptor antagonists. At present, they are still the main category of anti-ulcer drugs, and they are widely used clinically. Due to the important role of gastric acid in the pathogenesis of peptic ulcer, acid suppression therapy is the most important measure to relieve symptoms and ...

Claims

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Application Information

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Patent Type & AuthorityApplications(China)
IPC IPC(8): A61K9/10A61K33/06A61P1/04A61P1/14
Inventor乔敏袁靖尧袁武杰袁洲杰
OwnerSHANDONG SBOND PHARMA