Preparation method for glimepiride tablet

A technology of Glimex and urea tablets, which is applied in the field of medicine, can solve the problems of poor similarity of dissolution curves of reference preparations, high requirements for control of excipients, and poor similarity of dissolution curves, etc., to optimize the prescription process, improve similarity, Guaranteed dissolution effect

Inactive Publication Date: 2020-06-09
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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 glimepiride tablet, which uses cross-linked povidone and the hydrogen bond between povidone and glimepiride, adopts powder direct compression technology, and requires control of excipients Higher, the similarity between the prepared sample and the dissolution profile of the reference preparation is poor
[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 for glimepiride tablet
  • Preparation method for glimepiride tablet
  • Preparation method for glimepiride tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] A preparation method of glimepiride tablet, comprising the steps of:

[0067] (1) 30g of glimepiride raw material is pulverized with a universal pulverizer to obtain ordinary powder with a particle size D90 of about 150 μm;

[0068] (2) 15g povidone is configured into an aqueous solution of 15% concentration;

[0069] (3) Pass 30g of glimepiride raw material together with 1.8kg of lactose and 300g of sodium starch glycolate through a 100-mesh sieve and add to the fluidized bed;

[0070] (4) set fluidized bed inlet air temperature, fan frequency, spray pressure and liquid spray speed, spray povidone aqueous solution into fluidized bed for granulation, and dry;

[0071] The specific setting parameters are as follows: air intake volume 20HZ, air intake temperature 60°C, spray pressure 0.2Mpa, liquid spray speed 250r / min,

[0072] (5) After the dried granules are crushed and granulated with a 20-mesh granulator, 3 g of microcrystalline cellulose and 15 g of magnesium stea...

Embodiment 2

[0074] A preparation method of glimepiride tablets, comprising the following steps: (1) 25 g of glimepiride raw materials are pulverized by a universal pulverizer to obtain micropowder with a particle diameter D90 of less than 10 μm;

[0075] (2) 40g povidone is configured into 20% concentration of ethanol aqueous solution (2:3);

[0076] (3) 25g glimepiride, 1.8kg lactose, and 400g carboxymethyl starch sodium are passed through a 100-mesh sieve and added to the fluidized bed;

[0077] (4) Appropriate fluidized bed air inlet temperature, fan frequency, spray pressure and spray speed are set, and the povidone aqueous solution is sprayed into it to granulate and dry;

[0078] The specific setting parameters are as follows: air intake volume 20HZ, air intake temperature 50°C, spray pressure 0.3Mpa, liquid spray speed 300r / min.

[0079] (5) After the dried granules are crushed and granulated with a 20-mesh granulator, 20 g of microcrystalline cellulose and 40 g of magnesium stear...

Embodiment 3

[0081] Preparation method of prior art glimepiride tablets (our patent number is CN105769787A)

[0082] Micropowder the glimepiride raw material to below 10 μm, weigh 2kg of the glimepiride raw material, 55kg of lactose, 5.2kg of sodium carboxymethyl starch I (internal addition), 0.4kg of povidone, and 0.25kg of microcrystalline cellulose, Carboxymethyl starch sodium II (external addition) 1.9kg, magnesium stearate 0.325kg, glimepiride micropowder, lactose, carboxymethyl starch sodium I (internal addition) were added to the wet granulator and mixed for 20-30 minutes to obtain Glide meurea mixture;

[0083] (2) Add povidone into 9.6kg water and dissolve, and be mixed with 4% povidone aqueous solution (W / W);

[0084] (3) Add 4% povidone aqueous solution to make soft material in the wet granulator, add 14 mesh screens to granulate with a swing granulator, and dry the granules with a fluidized bed;

[0085] (4) Grind the dried granules with a 20 mesh, add microcrystalline cellul...

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Abstract

The invention relates to a preparation method for a glimepiride tablet. A formula technology of the glimepiride tablet is optimized, working procedures of granulation and drying are combined and simplified, glimepiride raw materials and lactose are added together as base materials, the glimepiride raw materials and the lactose are subjected to particle size regulation and control, proper mist spray pressure is adopted, and the dissolving property of raw materials in a fluidization and granulation process generates unexpected change, i.e., a dissolution rate can be guaranteed. Meanwhile, a similarity between an own product and a plurality of dissolution curves of a reference preparation can be improved, and an in vivo equivalence possibility with the reference preparation is 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): A61K9/20A61K31/64A61K47/26A61P3/10
CPCA61K9/2018A61K31/64A61P3/10
Inventor 陈用芳胡延贵杨绪凤樊竟洁
Owner CHONGQING CONQUER PHARML
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