Repaglinide and metformin hydrochloride tablet pharmaceutical composition and preparation method thereof

A technology of metformin tablets and metformin, which is applied in the direction of drug combinations, pharmaceutical formulas, medical preparations of non-active ingredients, etc., can solve problems such as uneven mixing of low-dose drug repaglinide, and achieve rapid dissolution and reduce exposure , the effect of promoting the efficacy of the drug

Active Publication Date: 2016-06-15
CHENGDU EASTON BIOPHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The purpose of the present invention is to provide a pharmaceutical composition of repaglinide metformin tablets, under the premise of ensuring product stability, realize the synchronous

Method used

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  • Repaglinide and metformin hydrochloride tablet pharmaceutical composition and preparation method thereof
  • Repaglinide and metformin hydrochloride tablet pharmaceutical composition and preparation method thereof
  • Repaglinide and metformin hydrochloride tablet pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0046] Example 1: Repaglinide metformin tablets prescription (based on 1000 tablets, unit: g):

[0047]

[0048]

[0049] Preparation Process:

[0050] Add 0.2g poloxamer, 0.5g meglumine and 0.6g povidone K30 into appropriate amount of water, stir to completely dissolve the materials, then slowly add 1g repaglinide, continue stirring to dissolve, and prepare repaglinide Solution: Take 15g of microcrystalline cellulose particles and place them in a spray pot on the top of a fluidized bed, set the inlet air temperature to 40~60℃, and the inlet air flow rate to 60~150m 3 / h, the atomization pressure is 1.0Pa, start the liquid supply pump, spray the repaglinide solution into the fluidized bed for granulation, and dry after spraying to obtain repaglinide granules; take 500g of metformin hydrochloride and add 16g povidone K30, 8g sorbitol, 4g polyethylene glycol 6000, placed in a granulating pot, mixed for 10 minutes, stirring while slowly adding an appropriate amount of water to granula...

Example Embodiment

[0051] Example 2: Repaglinide metformin tablets prescription (based on 1000 tablets, unit: g):

[0052]

[0053] Preparation Process:

[0054] Add 0.9g poloxamer, 1.0g meglumine and 1.2g povidone K30 into appropriate amount of water, stir to completely dissolve the material, then slowly add 2g repaglinide, continue stirring to dissolve, and prepare repaglinide Solution: Take 36g of microcrystalline cellulose particles and place them in a spray pot on top of a fluidized bed, set the inlet air temperature to 40~60℃, and the inlet air flow rate to 60~150m 3 / h, the atomization pressure is 1.5Pa, start the liquid supply pump, spray the repaglinide solution into the fluidized bed for granulation, and dry after spraying to obtain repaglinide granules; take 500g of metformin hydrochloride and add 22g povidone K30, 12g sorbitol, and 6g polyethylene glycol 6000 are placed in a granulating pot and mixed for 10 minutes. While stirring, add appropriate amount of water slowly to granulate. Use ...

Example Embodiment

[0055] Example 3: Repaglinide metformin tablets prescription (based on 1000 tablets, unit: g):

[0056]

[0057] Preparation Process:

[0058] Add 0.9g poloxamer, 1.0g meglumine and 1.2g povidone K30 into appropriate amount of water, stir to completely dissolve the material, then slowly add 1g repaglinide, continue stirring to dissolve, and prepare repaglinide Solution: Take 36g of microcrystalline cellulose particles and place them in a spray pot on top of a fluidized bed, set the inlet air temperature to 40~60℃, and the inlet air flow rate to 60~150m 3 / h, the atomization pressure is 2.0Pa, start the liquid supply pump, spray the repaglinide solution into the fluidized bed for granulation, and dry after spraying to obtain repaglinide granules; take 500g of metformin hydrochloride and add 20g povidone K30, 10g sorbitol, 5g polyethylene glycol 6000, placed in a granulating pot, mixed for 10 minutes, stirring while slowly adding an appropriate amount of water to granulate, and use a...

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Abstract

The invention provides a repaglinide and metformin hydrochloride tablet pharmaceutical composition; in a prescription, the amount of a disintegrating agent is greatly reduced compared with the prior art; in a process, microcrystalline cellulose particles are prepared in advance, repaglinide is made into a solution, repaglinide particles are prepared on the microcrystalline cellulose particles through fluidized bed atomizing, and the repaglinide particles are mixed and tabletted with metformin hydrochloride particles. The prepared repaglinide and metformin hydrochloride tablet product is stable, the insoluble drug repaglinide and the water-soluble drug metformin hydrochloride are both released synchronously according to requirements, and the bioavailability is better compared with that of the prior art; and at the same time, the problem of uneven mixing of the low-dosage drug repaglinide is solved, and the drug efficacy playing is greatly promoted.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pharmaceutical composition of repaglinide metformin tablets and a preparation method thereof. Background technique [0002] Repaglinide metformin tablets, the main ingredients are repaglinide and metformin hydrochloride. Repaglinide, the chemical name is S(+)-2-ethoxy-4-{2-[(3-methyl-1-(2-(1-piperidinyl)phenyl)butyl)amino ]-2-oxoethyl}benzoic acid, the chemical structural formula is: [0003] [0004] Metformin, its hydrochloride is commonly used clinically, that is, metformin hydrochloride, the chemical name is 1,1-dimethylbiguanide hydrochloride, and its chemical structure is: [0005] [0006] The compound composition of repaglinide and metformin hydrochloride can control the blood sugar level from two different ways. Metformin hydrochloride is a biguanide hypoglycemic drug. By inhibiting hepatic gluconeogenesis, reducing hepatic glucose output...

Claims

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Application Information

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IPC IPC(8): A61K31/451A61K31/155A61K9/20A61K47/38A61K47/32A61P3/10
CPCA61K9/1676A61K9/2077A61K31/155A61K31/451A61K47/32A61K47/38A61K2300/00
Inventor 王颖伍熹黄磊
Owner CHENGDU EASTON BIOPHARM CO LTD
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