Melbine/acarbose hypoglycemic oral preparation composition and preparation thereof

An oral preparation, metformin technology, applied in the field of medicine, can solve the problems of poor patient compliance, obvious toxic and side effects, missed doses, etc.

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

[0018] However, the combination of the two single preparations has the following disadvantages in the clinical application: the dosage of the single 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 singl

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1 (specification Acarbose 50mg: Metformin 250mg)

[0030] Enteric-coated capsules

[0031] prescription:

[0032] Metformin hydrochloride 295.85g (calculated as metformin 250.00g)

[0033] Acarbose 50.00g

[0034] Polyvinylpyrrolidone 25.00g

[0035] Fructose 29.00g

[0036] 50% ethanol appropriate amount

[0037]

[0038] Makes 1000 capsules

[0039] Preparation Process:

[0040] Pass metformin hydrochloride, acarbose, polyvinylpyrrolidone and fructose through a 100-mesh sieve respectively, weigh metformin hydrochloride, acarbose, polyvinylpyrrolidone and fructose according to the prescription amount and mix them uniformly in a mixer, then add an appropriate amount of 50 % ethanol solution to make soft material. Soft materials are granulated through a 20-mesh screen on the granulator. The granules prepared above were dried at 50° C., then passed through a swing granulator, and sized with a 18-mesh sieve. The content o...

Embodiment 2

[0041] Embodiment 2 (specification Acarbose 50mg: Metformin 150mg)

[0042] Enteric-coated capsules

[0043] prescription:

[0044] Metformin hydrochloride 177.51g (according to metformin 150.00g)

[0045] Acarbose 50.00g

[0046] Polyvinylpyrrolidone 18.00g

[0047] Starch 55.00g

[0048] 60% ethanol appropriate amount

[0049]

[0050] Makes 1000 capsules

[0051] Preparation Process:

[0052] Pass metformin hydrochloride, acarbose, polyvinylpyrrolidone and starch through a 100-mesh sieve respectively, weigh metformin hydrochloride, acarbose, polyvinylpyrrolidone and starch according to the prescription amount, put them in a mixer and mix them evenly, then add an appropriate amount of 60 % ethanol solution to make soft material. Soft materials are granulated through a 20-mesh screen on the granulator. The granules prepared above were dried at 50° C., then passed through a swing granulator, and sized with a 18-mesh sieve. The cont...

Embodiment 3

[0053] Embodiment 3 (specification acarbose 100mg: metformin 250mg)

[0054] tablet or enteric-coated tablet

[0055] prescription:

[0056] Metformin hydrochloride 295.85g (calculated as metformin 250.00g)

[0057] Acarbose 50.00g

[0058] Polyvinylpyrrolidone 25.00g

[0059] Pregelatinized starch 157.00g

[0060] Sodium carboxymethyl starch 20.00g

[0061] Magnesium Stearate 2.20g

[0062] 70% ethanol appropriate amount

[0063]

[0064] Makes 1000 pieces

[0065] Preparation Process:

[0066] Pass metformin hydrochloride, acarbose, polyvinylpyrrolidone, pregelatinized starch, sodium carboxymethyl starch, and magnesium stearate through a 100-mesh sieve, and weigh metformin hydrochloride, acarbose, and polyvinylpyrrolidone according to the prescription amount , pregelatinized starch, and sodium carboxymethyl starch are placed in a mixer and mixed evenly, and then an appropriate amount of 70% ethanol solution is added to make a soft...

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Abstract

The invention provides a melbine/acarbose hypoglycemic oral preparation composition and a preparation thereof. The weight ratio of the melbine to the acarbose comprised in the composition is 5:4 to 20:1, preferably, 5:2 to 10:1. Except the main medicaments, the composition also can further comprise 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, soft and hard capsules and sustained-release preparations by the common method, preferably enteric-coated tablets, enteric-coated granules and enteric-coated soft and hard 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 the condition that a melbine or sulfonylurea medicament cannot singly and effectively control the blood sugar, and also can be used for the interferential treatment of impaired glucose tolerance.

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): A61K31/7036A61K31/155A61P3/10
Inventor 张慧英安英张玲玲
Owner 北京瑞伊人科技发展有限公司
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