Preparation method of glimepiride tablets

A technology of glimeide and urea tablets, applied in the field of medicine, can solve the problems of poor similarity of the dissolution curve of the reference preparation, poor similarity of the dissolution curve, complicated preparation process, etc. Effects of chemical process steps

Inactive Publication Date: 2020-05-12
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] At present, in the existing technology, our company has applied for the invention patent with the patent authorization announcement number of CN102488667B, and announced a glimepiride tablet and its preparation method. The similarity of the dissolution curve of the product prepared according to the prescription process and the reference preparation Poor, at the same time, the particle size of the drug in this patent is controlled below 2 μm, the conditions are relatively harsh, and high-performance jet mill performance is required, as well as a lot of energy and manpower consumption
[0007] Our patent number is CN105769787A, which provides a preparation method for glimepiride tablets. The data of the prepared samples are good, but the similarity with the dissolution curve of the reference preparation is still poor.
[0008] The invention patent with the patent number CN109481408A provides a kind of glimepiride tablet, which uses the cross-linked povidone and the hydrogen bond between povidone and glimepiride, and adopts the powder direct compression technology to prepare the sample Poor similarity to the dissolution profile of the reference preparation
[0009] The invention patent with the patent number CN109432031A provides a glimepiride tablet, the glimepiride tablet includes an immediate-release layer and a sustained-release layer, the components of the immediate-release layer and the sustained-release layer are different, and the sustained-release layer needs to be freeze-dried Prepared as clathrate, the preparation process is more complicated

Method used

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  • Preparation method of glimepiride tablets
  • Preparation method of glimepiride tablets
  • Preparation method of glimepiride tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] A kind of preparation method of glimepiride tablet comprises the steps:

[0059] (1) The glimepiride raw material selects fine powder with a particle diameter D90 obtained by jet milling that is less than 5 μm;

[0060] Add 2kg of glimepiride, 65kg of lactose, 0.8kg of povidone, and 15kg of carboxymethyl starch sodium into a wet granulator and mix for 20 minutes, then add 10kg of purified water to make soft materials and shear and mix for 10 minutes, and then use the YK160A rocking granulator grain;

[0061] (2) Dry the wet granules with a boiling dryer at 80°C for 16 minutes, with a moisture content of 1.3%, and then pass through a crushing and sizing machine with a 20-mesh granulation, add 0.8 kg of microcrystalline cellulose, 0.5 kg of magnesium stearate and mix for 5 minutes, mix Speed ​​24rpm;

[0062] (3) When pressing the tablet, control the pressure to 6-9KN, and the hardness of the plain tablet is about 6kgf.

Embodiment 2

[0064] A preparation method of glimepiride tablet, comprising the steps of:

[0065] (1) The particle size D90 obtained by jet milling of raw materials is 5-10 μm;

[0066] Add 1.2kg of glimepiride, 90kg of lactose, 2kg of povidone, and 20kg of carboxymethyl starch sodium into a wet granulator and mix for 20 minutes, then add 10kg of purified water to make soft materials and shear and mix for 30 minutes, and then use the YK160A rocking granulator grain;

[0067] (2) Dry the wet granules with a boiling dryer at 80°C for 20 minutes, with a moisture content of 0.8%, and then pass through a 20-mesh crushing and sizing machine, add 1 kg of microcrystalline cellulose and 2 kg of magnesium stearate and mix for 5 minutes at a mixing speed of 24 rpm ;

[0068] (3) ZP35B tablet press machine, the control pressure is 3-6KN when pressing the tablet, and the hardness of the plain tablet is about 3kgf. Embodiment 3 (comparative example)

Embodiment 3

[0068] (3) ZP35B tablet press machine, the control pressure is 3-6KN when pressing the tablet, and the hardness of the plain tablet is about 3kgf. Embodiment 3 (comparative example)

[0069] A preparation method of glimepiride tablet, comprising the steps of:

[0070] (1) The particle size D90 obtained by jet milling of raw materials is a micropowder below 2 μm;

[0071] Add 2kg of glimepiride, 90kg of lactose, 0.5kg of povidone, and 5kg of carboxymethyl starch sodium into a wet granulator and mix for 20 minutes, then add 10kg of purified water to make soft materials and shear and mix for 2 minutes, and then use the YK160A rocking granulator grain;

[0072] (2) Dry the wet granules with a boiling dryer at 80°C for 16 minutes, with a moisture content of 0.9%, and then pass through a crushing and sizing machine with a 20-mesh granulation, add 0.1 kg of microcrystalline cellulose and 0.5 kg of magnesium stearate and mix for 5 minutes, and mix Speed ​​24rpm;

[0073] (3) When ...

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Abstract

The invention relates to a preparation method of glimepiride tablets. The preparation method of the glimepiride tablets comprises the following steps: taking micronized glimepiride as a raw material;mixing the micronized glimepiride with auxiliary materials with relatively good solubilization effects, namely lactose and povidone, for a long period of time; and then, adding a certain amount of water or an aqueous ethanol solution as a moistening agent. According to the preparation method of the glimepiride tablets, the time of shearing and mixing is increased, so that the solubilization effects are promoted; and magnesium stearate, which has relatively little influence on dissolution, is added for performing mixed tablet compression, so that the final dissolution rate of the main drug is ensured with similarity of several dissolution curves between the self-made product and the reference preparation improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a preparation method of glimepiride tablets. Background technique [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. Glimepiride h...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/64A61K47/38A61K47/26A61K47/32A61K47/12A61K47/36A61P3/10
CPCA61K9/2013A61K9/2018A61K9/2027A61K9/2054A61K9/2059A61K31/64A61P3/10
Inventor 陈用芳胡延贵杨绪凤樊竟洁
Owner CHONGQING CONQUER PHARML
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