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Preparation method of glimepiride tablets

A technology of Glimex and urea tablets, applied in the field of medicine and chemical industry, can solve the problems of poor similarity, achieve stable results, save time, and improve drug dissolution and bioavailability

Inactive Publication Date: 2020-09-01
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In view of the above-mentioned prior art features, the purpose of the present invention is to provide a preparation method of glimepiride tablets, which is used to solve the problem of poor similarity between the main drug and the multiple dissolution curves of the reference preparation in the preparation process of the prior art

Method used

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

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preparation example Construction

[0031] A preparation method of glimepiride tablet, is characterized in that, comprises the following steps:

[0032] S1. Micronize the glimepiride raw material drug by jet milling method, and control the particle size of the glimepiride raw material drug powder to be less than 10 μm;

[0033] S2. Weigh the glimepiride raw material powder and auxiliary materials pulverized in step S1 in proportion. The auxiliary materials include lactose, sodium starch glycolate, microcrystalline cellulose, pregelatinized starch, and magnesium stearate;

[0034] S3. Mix, pulverize and sieve the glimepiride raw material and lactose weighed in step S2, and add part of carboxymethyl starch sodium into a wet granulator for mixing to obtain a premixed powder;

[0035] S4, add povidone to the wet granulator in step S3, make soft material, granulate, fluidized bed drying;

[0036] S5, adding the dried granules to the remaining sodium starch glycolate, pregelatinized starch, and magnesium stearate wei...

Embodiment 1

[0042] A preparation method of glimepiride tablet, is characterized in that, comprises the following steps:

[0043]S1. Micronize the glimepiride raw material drug by jet milling method, and control the particle size of the glimepiride raw material drug powder to be less than 10 μm;

[0044] S2. Weigh 2kg of glimepiride raw material powder pulverized in step S1, 55kg of lactose, 5.2kg of sodium starch glycolate I, 0.4kg of povidone, 0.25kg of microcrystalline cellulose, and 1.9kg of sodium starch glycolate II in proportion. , magnesium stearate 0.325kg;

[0045] S3, mixing and pulverizing the glimepiride bulk drug and lactose weighed in step S2 through a 100-mesh sieve, and adding it to a wet granulator for mixing with sodium starch glycolate I for 25 minutes to obtain a premixed powder;

[0046] S4, the povidone in step S2 is formulated into 4% povidone aqueous solution, adds 4% povidone aqueous solution (W / W) to the wet granulator in step S3, makes soft material, passes Gr...

Embodiment 2

[0049] A preparation method of glimepiride tablet, is characterized in that, comprises the following steps:

[0050] S1. Micronize the glimepiride raw material drug by jet milling method, and control the particle size of the glimepiride raw material drug powder to be less than 5 μm;

[0051] S2. Weighing 0.7kg of glimepiride bulk drug powder pulverized in step S1, 58kg of lactose, 10kg of sodium starch glycolate, 0.35kg of povidone, 0.06kg of microcrystalline cellulose, 4kg of sodium starch glycolate II, stearin Magnesium acid 0.325kg;

[0052] S3, mixing and pulverizing the glimepiride bulk drug and lactose weighed in step S2 through a 100-mesh sieve, and adding it to a wet granulator for mixing with sodium starch glycolate I for 20 minutes to obtain a premixed powder;

[0053] S4, the povidone in step S2 is formulated into 4% povidone aqueous solution, adds 4% povidone aqueous solution (W / W) to the wet granulator in step S3, makes soft material, passes Granulate with a 20-...

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Abstract

The preparation method of the glimepiride tablet comprises the following steps: S1, micronizing a glimepiride raw material medicine by adopting an airflow crushing method, and controlling the particlesize of glimepiride raw material medicine powder to be less than 10 microns; S2, weighing the glimepiride raw material medicine powder crushed in the step S1 and auxiliary materials in proportion; S3, mixing, crushing and sieving the glimepiride raw material medicine weighed in the step S2 and lactose, and adding the mixture and part of carboxymethyl starch sodium into a wet granulator for mixingto obtain premixed powder; S4, adding povidone into the wet granulator in the step S3 to prepare a soft material, granulating, and drying in a fluidized bed; and S5, adding the dried granules into the remaining sodium carboxymethyl starch, pregelatinized starch and magnesium stearate weighed in the step S2, mixing, and tabletting. The invention solves the problem of poor similarity of multiple dissolution curves of the main drug and the reference preparation in the preparation process in the prior art.

Description

technical field [0001] The invention relates to the field of medicine and chemical industry, in particular 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. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/32A61K47/26A61K31/64A61P3/10
CPCA61K9/2018A61K9/2027A61K9/2095A61K31/64A61P3/10
Inventor 陈用芳樊竞洁杨绪凤胡延贵郭小龙薛云梅
Owner CHONGQING CONQUER PHARML
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