Method for preparing pharmaceutical composition containing repaglinide and metformin hydrochloride

A technology for metformin hydrochloride and metformin, applied in the field of medicine, can solve the problems of large specification of metformin hydrochloride, difficult to guarantee uniformity, small specification of repaglinide, etc., and achieves the effects of good fluidity, poor compressibility improvement, and stable process

Active Publication Date: 2014-04-09
CHINA RESOURCES SAIKE PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The purpose of the present invention is to provide a preparation method of a pharmaceutical composition containing repaglinide and metformin hydrochloride, and at the same time solve the problem that metformin hydrochloride has a large specification and poor compressibility, and repaglinide has a small specification and difficult to ensure uniformity , low solubility and poor dissolution

Method used

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  • Method for preparing pharmaceutical composition containing repaglinide and metformin hydrochloride
  • Method for preparing pharmaceutical composition containing repaglinide and metformin hydrochloride
  • Method for preparing pharmaceutical composition containing repaglinide and metformin hydrochloride

Examples

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Embodiment 1

[0018] Embodiment 1 (1000 pieces amount)

[0019]

[0020] Preparation:

[0021] 1) Dissolving repaglinide, meglumine, and poloxamer in ethanol solution to obtain a mixed solution;

[0022] 2) Grind metformin hydrochloride and sieve it for later use;

[0023] 3) Weigh the formulated amount of metformin hydrochloride, microcrystalline cellulose PH101, crospovidone XL-10 and polyethylene glycol 6000, and place them in a high-shear mixing granulator to mix evenly;

[0024] 4) Add the mixed solution obtained in step 1) into a high-shear granulator, stir evenly to make soft material, pass through a 2mm screen and use a lifting granulator to granulate, mix evenly and place it in a fluidized bed to dry, set the material temperature 60°C;

[0025] 5) Spray the prepared povidone K30 solution into the fluidized bed, set the parameters of atomization pressure and spray speed for one-step granulation, and set the material temperature to 60°C;

[0026] 6) Mix the prepared granules w...

Embodiment 2

[0028] Example 2 (quantity of 1000 tablets, unit: g)

[0029]

[0030] Preparation:

[0031] 1) Dissolving repaglinide, meglumine, and poloxamer in ethanol solution to obtain a mixed solution;

[0032] 2) Grind metformin hydrochloride and sieve it for later use;

[0033] 3) Weigh the formulated amount of metformin hydrochloride, microcrystalline cellulose PH101, crospovidone XL-10 and polyethylene glycol 6000, and place them in a high-shear mixing granulator to mix evenly;

[0034] 4) Add the mixed solution obtained in step 1) into a high-shear granulator, stir evenly to make soft material, pass through a 2mm screen and use a lifting granulator to granulate, mix evenly and place it in a fluidized bed to dry, set the material temperature 60°C;

[0035] 5) Spray the prepared povidone K30 solution into the fluidized bed, set the parameters of atomization pressure and spray speed for one-step granulation, and set the material temperature to 60°C;

[0036] 6) Mix the prepare...

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Abstract

The invention provides a method for preparing a pharmaceutical composition containing active ingredients such as repaglinide and metformin hydrochloride. The pharmaceutical composition comprises repaglinide, metformin hydrochloride and pharmaceutically acceptable excipients. The preparation method comprises the following steps: uniformly mixing repaglinide and metformin hydrochloride through a high-shear mixing granulator; directly injecting an adhesive solution into the repaglinide and metformin hydrochloride composition for granulating through a one-step granulation technology, and adding partial auxiliary materials for preparing into the tablets. The preparation method has the beneficial effects that repaglinide has high uniformity and high dissolution rate which is not influenced by pH, the problem that metformin hydrochloride is low in compressibility is solved, the pharmaceutical composition is stable in process, uniform in particles and high in liquidity, and the problems of mixing uniformity and dissolution rate of low-specification repaglinide and high-specification metformin hydrochloride are solved.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a preparation method of a pharmaceutical composition containing repaglinide and metformin hydrochloride. Background technique [0002] Repaglinide Metformin HCl Tablets (PrandiMet) is a drug developed by Novo Nordisk for the treatment of type 2 diabetes, officially approved by the US FDA in July 2008 On the market, the dosage specifications are repaglinide / metformin hydrochloride 1 mg / 500 mg and 2 mg / 500 mg. PrandiMet combines two drugs with different mechanisms of action to improve blood sugar control in people with type 2 diabetes. Repaglinide specifically binds to the KDA protein on the ATP-dependent potassium ion channel outside the islet β cell membrane, closing the potassium channel, depolarizing the β cell, opening the calcium channel, opening the calcium ion influx, promoting insulin secretion, and its action is faster than that of sulfonylureas. The postp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/451A61K9/20A61P3/10A61K31/155
Inventor 何凤娟薛超蒋玲敏王文峰
Owner CHINA RESOURCES SAIKE PHARMA
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