Magaldrate chewable tablets and preparation method thereof

Abstract

The invention provides magaldrate chewable tablets. The chewable tablets comprise magaldrate, a filling agent, a disintegrating agent, a flow aid and a lubricant. The chewable tablets are characterized in that no adhesive is required for the adhesion of magaldrate and the filling agent; calculated according to anhydrous magaldrate, a weight ratio of magaldrate to the filling agent to the disintegrating agent to the flow aid to the lubricant is 2-8:2-8:0.1-0.6:0.01-0.3:0.05-0.4. Also, the invention provides a preparation method of the magaldrate chewable tablets.

Description

technical field [0001] The invention belongs to the field of medicine, in particular, the invention relates to a chewable magnesium-aluminum tablet for treating hypersecretion of gastric acid and a preparation method thereof. technical background [0002] Gastrointestinal diseases such as gastric ulcer, duodenal ulcer and gastritis caused by excessive gastric acid secretion are the most common frequently-occurring diseases. Magnesium plus aluminum (magaldrate) is a commonly used antacid drug for the treatment of hyperacidity. It can not only prevent the occurrence of ulcers caused by increased gastric acid secretion (pyloric ligation type) and external acid-type stimulants (hydrochloric acid), but also treat non-acidity. Inhibits the formation of ulcers under secretion-stimulating conditions. . [0003] The molecular formula of magnesium plus aluminum hydrate is Al 5 Mg 10 (OH) 31 (SO 4 ) 2 ·xH 2 O, is the hydrate of magnesium aluminum basic salt. Magnesium plus alu...

AI Technical Summary

Problems solved by technology

Magnesium plus aluminum hydrate can be prepared by such as U.S. Patent US4639362A. The preparation method is relatively complicated. The freshly prepared magnesium plus aluminum hydrate in the form of hydrate is in the form of gel or jelly, which has considerable adhesiveness, but it is too large to be used. For transportation, long-term storage needs to add a small amount of antibacterial preservatives, otherwise it is prone to bacteria

Dehydrated magnesium plus aluminum powder can be obtained by drying, which is suitable for transportation and storage, so magnesium plus aluminum powder is currently commonly used in the pharmaceutical industry, but it cannot be completely restored to magnesium plus aluminum hydrate simply re-dissolved in water substance, will lose gel form or colloidal properties

Therefore, when preparing a solid pharmaceutical preparation containing magnesium plus aluminum powder, it is necessary to add an adhesive substance to help the solid form. As the inventors found, Chinese patent application 200810094304.3 skillfully utilizes the viscosity of alginic acid, which can be directly formulated into A compound solid pharmaceutical preparation comprising magnesium plus aluminum (powder) and alginic acid, but the document itself still suggests the use of a binder, and when lacking alginic acid, magnesium plus aluminum (powder) still needs a binder to form a larger of solid particles

[0004] For this reason, U.S. patent application US2004 / 0018249A1 treated the magnesium plus aluminum powder with water and mechanically milled to rehydrate it to form magnesium plus aluminum for the preparation of suspension pharmaceutical preparations, but the inventors found that, This method has the following disadvantages: 1) The milling process is time-consuming, which is not only unfavorable for improving the preparation efficiency, but also requires high conditions to maintain a sterile state during the milling process, so antibacterial preservatives will still be added during milling under low-cost conditions ; 2) The restored adhesiveness is not enough to replace the adhesive in solid dosage forms, but can only be used for pharmaceutical preparations formulated as suspensions

[0005] Since there are many types of antacid drugs commonly used, including a large number of aluminum salts and / or magnesium salt compounds, the recent developments in this field have paid less and less attention to the research and improvement of the specific drug of magnesium plus aluminum. In the literature on antacids or neutralizers, magnesium plus aluminum is only listed side by side with a large number of other aluminum salts and / or magnesium salt compounds, and the top-ranked antacids or neutralizers do not have the above-mentioned defects of magnesium plus aluminum , so that technicians have no incentive to specifically select magnesium plus aluminum for research

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