Glymiurea dispersion tablet and its preparation method

A technology for glimepiride and dispersible tablets, applied in the field of medicine, can solve the problems of affecting the quality of medicines, adverse drug dissolution and absorption, etc., and achieve the effects of prolonging storage period, taking convenience and ensuring quality

Inactive Publication Date: 2004-12-22
肖广常 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the dosage forms of glimepiride on the market at home and abroad include tablets and capsules. However, tablets and capsules generally disintegrate within 30 minutes, which is not conducive to drug dissolution and absorption.
In addition, due to the particularity of the hard capsule shell production process, hard capsules generally suffer from serious aging phenomena. After 1.5 years of storage, the disintegration time limit generally exceeds 40 minutes, or even does not disintegrate, thereby affecting the quality of the drug.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1: Glimepiride dispersible tablet, the components are as follows (all are weight ratio):

[0022] Glimepiride 10g 0.9%

[0023] Mannitol 400g 37.2%

[0024] Starch 300g 27.8%

[0025] Microcrystalline Cellulose 300g 27.8%

[0026] Croscarmellose Sodium 60 5.6%

[0027] Magnesium Stearate 5g 0.5%

[0028] Hypromellose 2g 0.2%

[0029] The preparation method is as follows (based on 10000 pieces): 1077

[0030] (1) Pass the glimepiride, mannitol, starch, and microcrystalline cellulose through a 100-mesh sieve, and set aside.

[0031] (2) Weigh 400g of mannitol, 300g of starch and 300g of microcrystalline cellulose according to the prescription, and mix them evenly. Add 10g of glimepiride in the prescribed amount, mix evenly, add 200g of binder 1% hypromellose aqueous solution to make a soft material, granulate with a 20-mesh sieve, dry at 50-60°C, granulate with a 20-mesh sieve, Add 60 g of croscarmellose sodium and 5 g of magnesium stearate and mix well...

Embodiment 2

[0036] Embodiment 2: Glimepiride dispersible tablet, the components are as follows (all are weight ratio):

[0037] Glimepiride 100g 10.3%

[0038] Lactose 300g 30.9%

[0039] Starch 200g 20.6%

[0040] Microcrystalline Cellulose 300g 30.9%

[0041] Low-substituted hydroxypropyl cellulose 60 6.1%

[0042] Silica 12g 1.2%

[0043] The preparation method is the same as in Example 1.

Embodiment 3

[0044] Embodiment 3: Glimepiride dispersible tablet, the components are as follows (all are weight ratio):

[0045] Glimepiride 55g 5.7%

[0046] Starch 500g 51.5%

[0047] Microcrystalline Cellulose 400g 41.3%

[0048] Hypromellose 15g 1.5%

[0049] The preparation method is the same as in Example 1.

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PUM

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Abstract

A dispersing glimepiride tablet for treating type-B diabetes is prepared from glimepiride, disintegrant, diluent, lubricant, flowing aid and adhesive through proportionally mixing, granulating, baking and tabletting.

Description

(1) Technical field [0001] The invention relates to glimepiride dispersible tablets and a preparation method thereof, belonging to the technical field of medicine. (2) Background technology [0002] Glimepiride is a new generation of sulfonylurea hypoglycemic drugs developed by the German company Hochst Mariom Roussel (HMR). It was first launched in Sweden under the trade name Amaryl in September 1995 and entered the US market with FDA approval in 1996. , for the treatment of type 2 diabetes uncontrolled by diet and exercise, it is the first FDA-approved sulfonylurea hypoglycemic drug that can be used simultaneously with insulin, due to the short duration of action of the drug and the receptor , to shorten the insulin secretion time, so it has a strong insulin-saving effect, and can overcome the secondary failure of islet cells to a certain extent. Glimepiride has high efficiency, long-term effect, and less side effects Small and other advantages, it is a sulfonylurea hypog...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/17A61P3/10
Inventor 肖广常张颖
Owner 肖广常
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