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Glimepiride tablet and preparation method thereof

A technology of Glimepiride and Glimepiride, which is applied in medical formulations, sulfonylurea active ingredients, and medical preparations of non-active ingredients, etc., can solve the problems of long time, strong viscosity, and high concentration, and reduce the dosage , improve hydrophilicity, and stabilize the results

Active Publication Date: 2013-04-17
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the invention also solves the problem that traditional binders such as hypromellose take a long time to swell in water, the concentration is too high, the viscosity is too strong, and the raw material drug of glimepiride contained in it is more difficult to release. The problem of reducing the effect of drugs on the dissolution rate, improving drug dissolution and bioavailability

Method used

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  • Glimepiride tablet and preparation method thereof
  • Glimepiride tablet and preparation method thereof
  • Glimepiride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Example 1 Preparation Method I of Glimepiride Tablets

[0019] Weigh 20g of glimepiride raw material, 360g of lactose, 100g of sodium starch glycolate, 200g of microcrystalline cellulose, 20g of microcrystalline silica gel, and 5g of magnesium stearate; prepare the glimepiride raw material by means of inert gas flow pulverization become particle size less than 2 mu m of glimepiride powder;

[0020] The glimepiride powder was mixed and ground for 90 minutes by adding lactose in increments, then mixed with microcrystalline cellulose and ground again for 30 minutes, and the grinding temperature was lower than 30°C to obtain a glimepiride-lactose mixture;

[0021] In the glimepiride-lactose mixture, carboxymethyl starch sodium and micropowder silica gel were put into the wet granulator and mixed for more than 3 minutes, and the aqueous solution containing 0.5% hypromellose by mass ratio was added to the wet granulator in a ratio of 1:20 as a binder. granulator granulati...

Embodiment 2

[0023] The preparation method II of embodiment 2 glimepiride sheet

[0024] Weigh 20g of glimepiride raw material, 360g of lactose, 100g of sodium starch glycolate, 200g of microcrystalline cellulose, 20g of microcrystalline silica gel, and 5g of magnesium stearate; prepare the glimepiride raw material by means of inert gas flow pulverization become particle size less than 2 mu m of glimepiride powder;

[0025] Glimepiride powder was mixed and ground for more than 60 minutes by adding lactose in increments, mixed with microcrystalline cellulose and ground again for more than 20 minutes, mixed with carboxymethyl starch sodium and micropowder silica gel and ground for more than 3 minutes, and the grinding temperature was lower than 30°C to obtain Glycine meurea mixture;

[0026] Add povidone dry powder into the glimepiride mixture and fully stir, mix and add magnesium stearate, control the hardness of the tablet press at 4 kg, and press the tablets to obtain glimepiride tabl...

Embodiment 3

[0027] Example 3 Preparation method I of prior art glimepiride tablets

[0028] Weigh 20g of glimepiride raw material, 360g of lactose, 100g of sodium starch glycolate, 200g of microcrystalline cellulose, 20g of microcrystalline silica gel, and 3.5g of magnesium stearate; grind and mix the glimepiride raw material with the prescribed amount of lactose After about 2 hours, the mixture was ground and mixed with microcrystalline cellulose for 30 minutes, and then mixed with the prescribed amount of sodium carboxymethyl starch and micropowder silica gel on a wet granulator for 8 minutes. Dissolve an appropriate amount of Tween 80 in 95% ethanol, then mix it with 1% hypromellose aqueous solution at a ratio of 1:20 as a binder, add it to the mixture of the wet granulator for granulation, dry it and then mix it with the prescription amount Magnesium stearate was blended and tabletted to obtain glimepiride tablets;

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Abstract

The invention discloses a Glimepiride tablet, wherein the Glimepiride tablet comprises the following components: Glimepiride tablet bulk pharmaceutical chemical, lactose, sodium starch glycolate, microcrystalline cellulose, microcrystalline silica gel and magnesium stearate at the weight ratio of (2-6):(60-90):(10-30):(10-60):(2-6):1, wherein the Glimepiride tablet bulk pharmaceutical chemical ispowder with the particle size less than 2 mu m. The invention also discloses a preparation method. With regard to Glimepiride, pharmaceuticals are smashed into particulates with the particle size less than 2mu m by an improved technology, and the hydrophilicity of the pharmaceuticals is improved; and the problem that the dissolution velocity of the pharmaceuticals is influenced is solved. Statistical analysis indicates that the average dissolution degree is above 98.5% by adopting the improved prescription and technology, and the accelerated test result for 6 months is very stable; and the research on primary pharmacokinetic parameters indicate that the preparation has the advantages of better dynamic course in human bodies and better absorption elimination properties through the checkingof statistics.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a glimepiride tablet and a preparation method thereof. technical background [0002] Glimepiride, chemical name 1-[4-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]benzenesulfonyl ]-3-(trans-4-methylcyclohexyl)urea, is a new sulfonylurea hypoglycemic agent, developed by the German company Hoechst Marion Roussel (HMR), first launched in Sweden under the trade name in September 1995 Amaryl was listed on the market and entered the U.S. market with FDA approval in 1996. It is used to treat type 2 diabetes that cannot be controlled by diet and exercise. It is the first sulfonylurea drug approved by the FDA that can be used simultaneously with insulin. Because the drug has a short action time with the receptor, it shortens the time for insulin secretion, so it has a strong insulin-sparing effect and can overcome the secondary failure of islet cells to a certain extent. Gl...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/64A61K47/38A61P3/10
Inventor 梅勇罗磊何远东马贵勇姜艳红
Owner CHONGQING CONQUER PHARML
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