A pharmaceutical composition containing repaglinide metformin and its preparation method

A technology of metformin tablets and metformin hydrochloride, which is applied in the field of pharmaceutical preparations and can solve the problems of metformin not being able to achieve synchronous release, uneven content of repaglinide, and complicated processes

Inactive Publication Date: 2019-09-10
SICHUAN HAISCO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the conventional means adopted in the prior art of the pharmaceutical composition containing repaglinide and metformin all have shortcomings such as uneven content of repaglinide, low dissolution rate, and inability to achieve synchronous release with metformin.
CN102247370A, CN101843617A, CN103371981A, etc. adopt slow and controlled release and multi-layer tablet means to solve this problem, but the process is complicated and the cost is high

Method used

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  • A pharmaceutical composition containing repaglinide metformin and its preparation method
  • A pharmaceutical composition containing repaglinide metformin and its preparation method
  • A pharmaceutical composition containing repaglinide metformin and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0116] Embodiment 1 Preparation of pharmaceutical composition containing repaglinide metformin

[0117] prescription:

[0118]

[0119] The preparation method is prepared according to the following steps:

[0120] 1) Processing of raw and auxiliary materials:

[0121] Micronize repaglinide bulk drug so that d(0.9)≤10 μm, and set aside;

[0122] Metformin hydrochloride 100 mesh sieves are pulverized for subsequent use;

[0123] Crospovidone, meglumine, and sodium lauryl sulfate are passed through a 60-mesh sieve, and set aside;

[0124] 2) Premix:

[0125] a. Take about 2 / 3 of the amount of microcrystalline cellulose, 1 / 2 of the amount of hypromellose, about 2 / 3 of the amount of crospovidone, silicon dioxide and about 1 / 2 of the amount The metformin hydrochloride is put into a multidirectional motion mixer and mixed for 5 to 10 minutes, then the remaining metformin hydrochloride is added to the mixer and mixed for 5 to 10 minutes, dispersed through a 50-mesh sieve to ob...

Embodiment 2

[0138] Embodiment 2 Preparation of pharmaceutical composition containing repaglinide metformin

[0139] prescription:

[0140]

[0141] The preparation method is prepared according to the following steps:

[0142] 1) Processing of raw and auxiliary materials:

[0143] Micronize repaglinide bulk drug so that d(0.9)≤10 μm, and set aside;

[0144] Metformin hydrochloride 120 mesh sieves are pulverized for subsequent use;

[0145] Crospovidone, meglumine, and sodium lauryl sulfate are passed through a 60-mesh sieve, and set aside;

[0146] 2) Premix:

[0147] a. Take half of the amount of microcrystalline cellulose, half of the amount of hypromellose, 1 / 3 of the amount of crospovidone, silicon dioxide and 1 / 4 of the amount of metformin hydrochloride, and put them into a multi-directional motion mixer Mix for 5-10 minutes, then add the remaining metformin hydrochloride into the mixer and mix for 5-10 minutes, disperse with a 30-mesh sieve to obtain the mixture ①, set aside;...

Embodiment 3

[0160] Embodiment 3 Preparation of pharmaceutical composition containing repaglinide metformin

[0161] prescription:

[0162]

[0163]

[0164] The preparation method is prepared according to the following steps:

[0165] 1) Processing of raw and auxiliary materials:

[0166] Micronize repaglinide bulk drug so that d(0.9)≤10 μm, and set aside;

[0167] Metformin hydrochloride 120 mesh sieves are pulverized for subsequent use;

[0168] Crospovidone, meglumine, and sodium lauryl sulfate are passed through a 60-mesh sieve, and set aside;

[0169] 2) Premix:

[0170]a. Take about two-thirds of microcrystalline cellulose, two-thirds of hypromellose, one-half of crospovidone, silicon dioxide and about one-third of Metformin hydrochloride is put into a multidirectional motion mixer and mixed for 5 to 10 minutes, then the remaining metformin hydrochloride is added to the mixer and mixed for 5 to 10 minutes, dispersed through a 30-mesh sieve to obtain the mixture ①, and set...

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Abstract

The invention discloses medicine composition containing repaglinide and metformin and a preparation method of the medicine composition. A tablet is proportionally composited by meglumine, silicon dioxide, microcrystalline cellulose, lauryl sodium sulfate, hydroxypropyl methylcellulose, polyvinylpolypyrrolidone, magnesium stearate, repaglinide and metformin hydrochloride, repaglinide and metformin are granulated with a multistep mixing method in combination of a stirring, cutting and granulation technology, the compressibility of granules is guaranteed, meanwhile, the content uniformity of repaglinide is improved, the dissolution rate of metformin in the tablet is increased, the process is simple, and the medicine composition is suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing repaglinide metformin and a preparation method thereof. Background technique [0002] Type Ⅱ diabetes is a common multiple chronic metabolic disease that seriously endangers human health. Prolonged illness can lead to progressive damage to multiple systems and organs. Effective control of blood sugar can delay the development of complications. At present, there is no cure for type 2 diabetes. Most of them are based on diet and exercise therapy. The scientific and reasonable use of hypoglycemic drugs is the key to ensuring long-term compliance of patients, successful treatment and reduction of complications. [0003] Metformin, whose chemical name is 1,1-dimethylbiguanide (structure shown in formula I), is currently the most widely used hypoglycemic agent and plays an important role in the treatment of type 2 diabetes. Metformin p...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/451A61K9/30A61P3/10
Inventor 任东冯卫刘波
Owner SICHUAN HAISCO PHARMA CO LTD
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