Acarbose pharmaceutical composition and preparation method thereof

Abstract

The invention discloses acarbose pharmaceutical composition and a preparation method thereof in order to overcome defects that conventional acarbose tablets are prone to moisture absorption, slow to disintegrate, difficult to prepare and the like. The acarbose pharmaceutical composition is prepared from components in parts by weight as follows: 1 part of the acarbose, 1-4 parts of a filling agent, 0.001-0.005 parts of a lubricating agent and 0.005-0.01 parts of a flow aid, wherein the filling agent comprises microcrystalline cellulose and pregelatinized starch. The preparation method comprises steps as follows: the acarbose and the pregelatinized starch with good fluidity are subjected to first-stage mixing, a mixture and the residual filling agent are subjected to second-stage mixing, and finally, the lubricating agent and the flow aid are added for third-stage mixing. The acarbose pharmaceutical composition is free of a disintegrating agent, and a disintegration property of a product is realized by the aid of disintegration performance or a disintegration assistant effect of auxiliary material characteristics of the pregelatinized starch and the microcrystalline cellulose. The requirement for product quality is met with a staged mixing and powder direct-tabletting technology, the technology is simple, and large-scale production is facilitated.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing acarbose and a preparation method thereof. Background technique [0002] Acarbose (Acarbose), is a kind of medicine for the treatment of type II diabetes developed by German Bayer in the mid-1970s, and is now the first brand of oral hypoglycemic drugs. Its chemical name is: O-4,6-dideoxy-4-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)-2-cyclohexyl Alkenyl-1-yl]amino]-α-D-glucopyranosyl-(1→4)-O-α-D-glucopyranose-(1→4)-D-glucopyranose, pioneered in 1990 It was listed in Germany, and was approved by the FDA in 1996 to be listed in the United States. In 1998, acarbose entered China with the product name "Baitangping". The structural formula is as follows: [0003] [0004] Acarbose is mainly used in the treatment of type 2 diabetes. Competitively inhibits glucoside hydrolases in the gut. Inhibit α-glucosidase in the small...

AI Technical Summary

Problems solved by technology

[0015] The technical problem to be solved by the present invention is to overcome the defects of the above-mentioned existing tablets such as easy moisture absorption and slow disintegration, and provide a kind of acarbose pharmaceutical composition without disintegrants and suitable for powder direct compression into tablets. Prevent the drug from slowly disintegrating due to moisture absorption when it is made into tablets, and avoid affecting the efficacy of the drug

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