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Repaglinide and metformin hydrochloride medicinal composition and its preparation method

A technology for metformin hydrochloride and a composition is applied in the field of pharmaceutical compositions containing repaglinide and metformin hydrochloride and the field of preparation thereof, which can solve the problems of complicated preparation process and high production cost, and achieve good fluidity, low friability, Good tablet hardness

Active Publication Date: 2013-05-01
CHINA RESOURCES SAIKE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation process uses special auxiliary materials and the preparation process is complicated, and the production cost is high

Method used

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  • Repaglinide and metformin hydrochloride medicinal composition and its preparation method
  • Repaglinide and metformin hydrochloride medicinal composition and its preparation method
  • Repaglinide and metformin hydrochloride medicinal composition and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-4

[0047] Embodiment 1-4, tablet

[0048] The preferred formulation of the pharmaceutical composition of the present invention is as follows: prescription (quantity of 1000 tablets, unit: g)

[0049]

[0050] The composition preparation method of the present invention comprises the following steps:

[0051] a) Dissolving poloxamer and meglumine in 50% ethanol, then adding repaglinide, and then adding povidone after dissolving;

[0052] b) Metformin hydrochloride is pulverized through a 60-mesh sieve, and mannitol is passed through a 30-mesh sieve for subsequent use;

[0053] c) Weigh the prescribed amount of metformin hydrochloride, microcrystalline cellulose, crospovidone, mannitol and polyethylene glycol 6000 and put them in the fluidized bed, and set the air intake volume to 500±200m 3 / h, air inlet temperature 90±5℃, product temperature 70±5℃, hot melt granulation;

[0054] d) Spray the repaglinide solution into the fluidized bed, set the atomization pressure to 1.0±0.2...

Embodiment 5-6

[0059] Embodiment 5-6, tablet of the present invention

[0060]

[0061] The composition preparation method of the present invention comprises the following steps:

[0062] a) Dissolving poloxamer and meglumine in 50% ethanol, then adding repaglinide, and then adding povidone after dissolving;

[0063] b) Metformin hydrochloride is pulverized through a 60-mesh sieve, and mannitol is passed through a 30-mesh sieve for subsequent use;

[0064] c) Weigh the prescribed amount of metformin hydrochloride, microcrystalline cellulose, crospovidone, mannitol and polyethylene glycol 6000 and put them in the fluidized bed, and set the air intake volume to 500±200m 3 / h, air inlet temperature 90±5℃, product temperature 70±5℃, hot melt granulation;

[0065] d) Spray the repaglinide solution into the fluidized bed, set the atomization pressure to 1.0±0.2bar, and the spray speed to 30±10Hz, and perform one-step granulation;

[0066] e) passing the prepared granules through a 1.0mm roun...

experiment example 1

[0070] Experimental example 1, the physical property determination of granule of the present invention and tablet

[0071] Get the granule and tablet of above-mentioned embodiment 1-6, carry out granule fluidity, tablet hardness, friability test

[0072] The results of particle fluidity (angle of repose), bulk density, tapped density, tablet hardness and friability are shown in the table below:

[0073]

[0074] From the results in the table above, it can be seen that the fluidity of the granules of Examples 1-6 is not much different, the tablet hardness is suitable, and the friability is small.

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Abstract

The invention provides a medicinal composition including active components of repaglinide and metformin hydrochloride, and its preparation method. The method comprises the following steps: carrying out hot melting granulation of metformin hydrochloride to prepare particles, directly spraying a repaglinide solution on the metformin hydrochloride particles through a one-step granulation technology, and adding parts of auxiliary materials to prepare a tablet.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and more specifically relates to a pharmaceutical composition containing repaglinide and metformin hydrochloride and a preparation method thereof. Background technique [0002] The incidence of diabetes is increasing year by year, and China has become the hardest hit area, and the number of diabetic patients ranks second in the world. According to pathological characteristics, diabetes can be divided into two types: type 1 diabetes, namely insulin-dependent (IDDM) diabetes, patients of this type must rely on exogenous insulin to maintain life, and most of them are severe; type 2 diabetes, that is, non-insulin-dependent diabetes (NIDDM) Diabetes, this type of patients do not need to rely on exogenous insulin to maintain life, most of them are adults, but can also be seen in adolescents, most of the patients are obese, insulin receptors are not sensitive, this type accounts for at least 8...

Claims

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Application Information

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IPC IPC(8): A61K31/451A61K31/155A61K9/20A61P3/10
Inventor 王再全关津王文峰杨琰刘蕴秀刘博雅张松涛张国松
Owner CHINA RESOURCES SAIKE PHARMA
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