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Acarbose drug combination and preparing method thereof

A technology for acarbose and its composition, which is applied in the field of acarbose composition and its preparation, can solve the problems of obvious increase of related substances, severe color change, poor preparation stability, etc., and achieve reduction of hygroscopicity, simple moisture, good stability effect

Active Publication Date: 2015-10-28
SUZHOU CHUNGHWA CHEM & PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Therefore, the technical problem to be solved by the present invention is to overcome the technical defects of the existing acarbose pharmaceutical composition that it is easy to absorb moisture, the related substances increase significantly, the degree of color change is serious, and the stability of the preparation is poor, thereby proposing a low-moisture, non-hygroscopic Acarbose pharmaceutical composition with certain moisture-proof performance and good stability and preparation method

Method used

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  • Acarbose drug combination and preparing method thereof
  • Acarbose drug combination and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Embodiment 1: Acarbose tablet

[0037] Raw materials

Dosage (g)

Acarbose

50

anhydrous lactose

50

low moisture starch

30

silica

4

Magnesium stearate

1

[0038] The preparation steps are as follows:

[0039] (1) Take the raw and auxiliary materials and sieve them respectively;

[0040] (2) Mix acarbose and silicon dioxide evenly first, then mix evenly with anhydrous lactose and low-moisture starch, then add magnesium stearate and mix evenly;

[0041] (3) Tablets.

Embodiment 2

[0042] Embodiment 2: Acarbose tablet

[0043] Raw materials

Dosage (g)

Acarbose

50

anhydrous lactose

50

low moisture starch

30

silica

4

80% ethanol

Appropriate amount

Magnesium stearate

1

[0044] The preparation steps are as follows:

[0045] (1) Take the raw and auxiliary materials and sieve them respectively;

[0046] (2) Mix acarbose and silicon dioxide evenly first, and then mix evenly with anhydrous lactose and low-moisture starch;

[0047] (3) Granulate it with 80% ethanol solution, pass through a 20-mesh sieve for granulation, and dry;

[0048] (4) Add magnesium stearate, mix well and then compress into tablets.

Embodiment 3

[0051] The preparation steps are as follows:

[0052] (1) Take the raw and auxiliary materials and sieve them respectively;

[0053] (2) Mix acarbose and silicon dioxide evenly first, and then mix evenly with anhydrous lactose and low-moisture starch;

[0054] (3) Granulate it with 10% ethyl cellulose solution (prepared by appropriate amount of 80% ethanol), pass through a 20-mesh sieve for granulation, and dry;

[0055] (4) Add magnesium stearate, mix well and then compress into tablets.

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Abstract

The invention discloses an acarbose drug combination and a preparing method thereof and particularly relates to an acarbose tablet. According to the composition, a filling agent is one or more of lactose anhydrous and low-moisture starch. Compared with the prior art, the acarbose drug combination and the preparing method thereof have the advantages that by selecting the varieties of auxiliary materials in the tablet, the acarbose drug combination which is prepared through a simple preparation technology and is low in moisture content, not prone to moisture absorption, resistant to humidity to a certain extent and high in stability is provided. The product prepared through the method is high in stability, the stability of all item indexes such as the appearance of the tablet and the impurities is obviously superior to those of acarbose sold on the market of Bayer; in addition, the preparation technology is simple and easy to control, the production efficiency is high, and energy consumption for production is low.

Description

technical field [0001] The invention relates to an acarbose composition for treating diabetes and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Acarbose, chemical name: O-4,6-dideoxy-4[[(1S,4R,5S,6S)4,5,6-trihydroxy-3-(hydroxymethyl)-2-cyclohexyl En]amino]-(-D-glucopyranosyl(1→4)-O-)-D-glucopyranosyl(1→4)-D-glucopyranosyl. Acarbose was successfully developed by Bayer AG of Germany and launched in Germany in 1990. It was launched on the market in my country in 1994. It is a new type of oral hypoglycemic drug. It is a biosynthetic pseudotetrasaccharide that can reduce the rise in blood sugar after meals and reduce the average blood sugar level. It is almost parenteral. Therefore, systemic adverse reactions are rare, and only manifest as mild to moderate local gastrointestinal discomfort, which can improve patients' compliance and tolerance to treatment. Therefore, acarbose is more and more valued and used b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/26A61K47/36A61K47/38A61K31/7036A61K9/20A61K9/36A61P3/10
Inventor 钱颖马晓华李远福
Owner SUZHOU CHUNGHWA CHEM & PHARMA IND
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