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Melbine/migltol hypoglycemic oral preparation composition and preparation thereof

An oral preparation, the technology of metformin, applied in the field of medicine, can solve the problems of large dosage, poor patient compliance, and no reports of metformin/miglitol hypoglycemic oral preparations.

Inactive Publication Date: 2010-06-30
北京瑞伊人科技发展有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] However, the combined application of the two unilateral preparations has the following defects: the dosage of the unilateral preparation is large, so the toxic and side effects are obvious; the patient's compliance is poor, and it is troublesome to take the two unilateral preparations at the same time, and there are phenomena of missed doses and overdoses
[0012] According to the search results of relevant patents and prior art literature, there are no relevant reports on the metformin / miglitol hypoglycemic oral preparation composition and its preparation

Method used

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  • Melbine/migltol hypoglycemic oral preparation composition and preparation thereof
  • Melbine/migltol hypoglycemic oral preparation composition and preparation thereof
  • Melbine/migltol hypoglycemic oral preparation composition and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Enteric-coated capsules (Specification Miglitol 100mg: Metformin 250mg)

[0023] prescription:

[0024] Metformin hydrochloride 295.85g (calculated as metformin 250.00g)

[0025] Miglitol 100.00g

[0026] Microcrystalline Cellulose 84.15g

[0027] Polyvinylpyrrolidone 20.00g

[0028] 60% ethanol appropriate amount

[0029]

[0030] Made into 1000 capsules

[0031] Preparation Process:

[0032] Pass metformin hydrochloride, miglitol, microcrystalline cellulose, and polyvinylpyrrolidone through a 100-mesh sieve respectively; weigh metformin hydrochloride, miglitol, microcrystalline cellulose, and polyvinylpyrrolidone in a mixer according to the prescription amount, and mix uniform; adding an appropriate amount of 60% ethanol solution to make soft material; the soft material is granulated through a 20-mesh screen on the granulator. Granules; measure the content of the mixed granules, and determine the volume range of the enteric-co...

Embodiment 2

[0034] Granules (Specification: Miglitol 100mg: Metformin 250mg; 0.75g / bag)

[0035] prescription:

[0036]Metformin hydrochloride 295.85g (calculated as metformin 250.00g)

[0037] Miglitol 100.00g

[0038] Fructose 105.00g

[0039] Starch 229.15g

[0040] Citric acid 17.00g

[0041] 65% ethanol appropriate amount

[0042]

[0043] Made into 1000 bags

[0044] Preparation Process:

[0045] Pass metformin hydrochloride, miglitol, fructose, starch, and citric acid through a 100-mesh sieve respectively; weigh metformin hydrochloride, miglitol, fructose, starch, and citric acid according to the prescription amount and place them in a mixer to fully mix; add an appropriate amount of The 65% ethanol solution is made into soft materials, and the soft materials are granulated through a 18-mesh sieve on a oscillating granulator; after drying the prepared granules at 50°C, they are granulated through a 16-mesh sieve through a oscillating g...

Embodiment 3

[0047] Granules (Specification Miglitol 25mg: Metformin 500mg; 1g / bag)

[0048] prescription:

[0049] Metformin hydrochloride 591.70g (according to metformin 500.00g)

[0050] Miglitol 25.00g

[0051] Polyvinylpyrrolidone 30.00g

[0052] Fructose 128.00g

[0053] Microcrystalline Cellulose 210.30g

[0054] Citric acid 15.00g

[0055] 75% ethanol appropriate amount

[0056]

[0057] Made into 1000 bags

[0058] Preparation Process:

[0059] Pass metformin hydrochloride, miglitol, polyvinylpyrrolidone, fructose, microcrystalline cellulose, and citric acid through a 100-mesh sieve respectively; weigh metformin hydrochloride, miglitol, polyvinylpyrrolidone, fructose, and microcrystalline cellulose Put the vegetable and citric acid in a mixer and mix them evenly; add an appropriate amount of 75% ethanol solution to make a soft material; the soft material is granulated through an 18-mesh screen on a swinging granulator; The swinging g...

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Abstract

The invention provides a melbine / migltol hypoglycemic oral preparation composition and a preparation thereof. The weight ratio of the two main medicaments comprised in the composition is 2:3 to 200:1, preferably, 1:1 to 150:1. Except the main medicaments, the composition also can further comprises normal medicament auxiliary materials, such as an adhesive, a filling agent, a disintegrating agent, a lubricating agent, a flavoring agent, a wetting agent and a glidant. The prepared composition can be prepared into tablets, granules, capsules and sustained-release preparations by the common method, preferably, enteric-coated tablets, enteric-coated granules and enteric-coated capsules. The composition of the invention has the advantages of complementarity of action mechanisms of the main medicaments, multiple target points, good patient compliance and the like. The hypoglycemic oral preparation composition can be used for first-line treatment of type 2 diabetes, or can be used for second-line therapy under the condition that a melbine or sulfonylurea medicament cannot singly and effectively control the blood sugar.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a hypoglycemic oral preparation composition and its preparation. Background technique [0002] Diabetes is a common and frequently-occurring disease. The latest statistics from the International Diabetes Federation show that in the past 20 years, the number of people with diabetes worldwide has increased from 30 million to 230 million. Experts estimate that within 20 years, the total number of people with diabetes worldwide will increase to 350 million. At present, about 3 million people die from diabetes every year worldwide, and the mortality rate will increase to 25% in the next ten years. If diabetes is not treated in time or poorly controlled, it can lead to various complications, such as ①Diabetic nephropathy: kidney function damage, so that the kidney cannot retain useful protein for the human body, and cannot excrete waste, causing edema, (lower limbs, face, etc.) Obviou...

Claims

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Application Information

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IPC IPC(8): A61K31/445A61K31/155A61P3/10
Inventor 安英张慧英张玲玲
Owner 北京瑞伊人科技发展有限公司
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