Compound repaglinide-metformin hydrochloride solid quick-release preparation and preparation method and application thereof

A technology of metformin hydrochloride and immediate-release preparations, which is applied in the field of medicine and can solve problems such as the increase of repaglinide substances

Inactive Publication Date: 2013-10-30
TIANJIN INSTITUTE OF PHARMA RESEARCH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The present invention provides a solid compound preparation with repaglinide and metformin hydrochloride as active ingredients and a preparation method thereof, mainly to solve the problem of rapid release of repaglinide, an insoluble water-soluble drug, and related substances of repaglinide during placement additional questions

Method used

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  • Compound repaglinide-metformin hydrochloride solid quick-release preparation and preparation method and application thereof
  • Compound repaglinide-metformin hydrochloride solid quick-release preparation and preparation method and application thereof
  • Compound repaglinide-metformin hydrochloride solid quick-release preparation and preparation method and application thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Investigation on the stability of influencing factors for immediate-release tablets obtained by two preparation processes

[0030] Compound repaglinide-metformin hydrochloride immediate-release tablets are prepared by two preparation processes, one is to mix repaglinide and metformin hydrochloride together with excipients for tablet compression, and the other is to mix repaglinide and metformin hydrochloride Metformin is separately mixed with auxiliary materials to make granules, and then the granules are mixed for tabletting.

[0031] Prescription of Compound Immediate Release Tablets Containing Repaglinide 1mg Metformin Hydrochloride 500mg (500 Tablets)

[0032]

[0033]Preparation method 1: Grind metformin hydrochloride and various auxiliary materials separately, and pass through an 80-mesh sieve. The repaglinide was pulverized and passed through a 250-mesh sieve. Take the pulverized main drug and lactose according to the prescription amount, weigh 5g of crospov...

Embodiment 2

[0049] Prescription of Compound Immediate Release Tablets Containing Repaglinide 2mg Metformin Hydrochloride 500mg (500 Tablets)

[0050] (1) Repaglinide Granules

[0051]

[0052] (2) Metformin Hydrochloride Granules

[0053]

[0054]

[0055] (3) Accessories

[0056] Magnesium Stearate 3g

[0057] Crospovidone 4g

[0058] Preparation method: Grind metformin hydrochloride and various auxiliary materials separately, and pass through 80-mesh sieve. The repaglinide was pulverized and passed through a 250-mesh sieve. Weigh repaglinide, poloxamer 188, microcrystalline cellulose and crospovidone according to the prescription amount, and mix well; weigh 0.8g PVP K30 and add water to prepare a 25% solution, add the mixed Repaglinide and fine powder of auxiliary materials are used to make a suitable soft material; the prepared soft material is made into wet granules through a 40-mesh sieve, and the wet granules are dried at 40°C to obtain dry granules; the dry granules a...

Embodiment 3

[0060] Prescription of Compound Immediate Release Tablets Containing Repaglinide 2mg Metformin Hydrochloride 1000mg (500 Tablets)

[0061] (1) Repaglinide Granules

[0062]

[0063] (2) Metformin Hydrochloride Granules

[0064]

[0065]

[0066] (3) Accessories

[0067] Glyceryl Behenate 2.9g

[0068] Croscarmellose Sodium 6g

[0069] Preparation method: Grind metformin hydrochloride and various auxiliary materials separately, and pass through 80-mesh sieve. The repaglinide is pulverized by airflow, and the particle size of more than 90% of the pulverized powder is controlled to be below 20 μm. Weigh repaglinide, mannitol and croscarmellose sodium according to the prescription amount, and mix well; weigh 0.7g PVP K30 and add water to make a 25% solution, add the mixed repaglinide, auxiliary materials Fine powder, make suitable soft material; pass the prepared soft material through a 40-mesh sieve to make wet granules, dry the wet granules at 40°C to obtain dry gr...

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Abstract

The invention relates to a compound repaglinide-metformin hydrochloride solid quick-release preparation and a preparation method and an application thereof, and belongs to the technical field of medicines. A quick-release tablet is prepared from repaglinide and metformin hydrochloride which are taken as medicinal active components, and suitable medicinal auxiliary materials, and the problems of quick dissolution-out of the indissolvable medicine, namely, repaglinide and the stability of the repaglinide in a tablet placement process are solved. The preparation method comprises the following steps of: respectively granulating the repaglinide and the metformin hydrochloride by selecting the suitable medicinal auxiliary materials; mixing, and then pressing into tablets, or filling into capsules. The prepared compound preparation has a synergetic effect on controlling blood sugar and improving the curative effect and is convenient for patients to take.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a solid compound immediate-release preparation of repaglinide and metformin hydrochloride, a preparation method and application thereof. Background technique [0002] Diabetes is a combination of sugar, protein, fat, water, and A series of metabolic disorder syndromes such as electrolytes are clinically characterized by high blood sugar. Once the blood sugar is not well controlled, it will cause complications and lead to failure of the kidneys, eyes, feet and other parts. According to the pathological features displayed by diabetic patients, it is mainly divided into type 1 diabetes and type 2 diabetes. Type 1 diabetes is insulin-dependent, due to the lack of insulin secretion, it relies on exogenous insulin supplementation to maintain life. Type 2 diabetes is non-insulin-dependent, characterized by the body's own ability to produce insulin, but the cells cannot respond to it,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/48A61K31/451A61P3/10A61K31/155
Inventor 王杏林尹东东张俊伟杨志强
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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