Metformin hydrochloride/voglibose sugar-lowering oral preparation composition and preparation method thereof

A technology of metformin hydrochloride and voglibose, which is applied in the field of medicine and can solve problems such as no report on metformin hydrochloride/voglibose oral hypoglycemic preparation composition

Inactive Publication Date: 2009-12-02
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] According to the search results of relevant patents and prior art literature, there is no relevant report on the combination of metformin hydrochloride / voglibose hypoglycemic oral preparations

Method used

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  • Metformin hydrochloride/voglibose sugar-lowering oral preparation composition and preparation method thereof
  • Metformin hydrochloride/voglibose sugar-lowering oral preparation composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Example 1 (specification voglibose 0.1mg: metformin hydrochloride 250mg)

[0019] Make enteric-coated capsules, taking 1000 capsules as an example, take 295.85g of metformin hydrochloride (calculated as 250.00g of metformin hydrochloride), 0.10g of voglibose, 180.00g of microcrystalline cellulose, and 25.00g of polyvinylpyrrolidone over 100 g respectively. Mesh sieve, in a mixer, fully mixed, add an appropriate amount of 60% ethanol solution to make a soft material. Soft materials are granulated through a 20-mesh screen on the granulator. The granules prepared above were dried at 50° C. for 30 min. Then pass through a swinging granulator, and use a 18-mesh sieve to granulate. The content of the mixed granules is determined, and the capacity range of the enteric-coated capsule shell is determined. After passing the inspection, pack.

Embodiment 2

[0020] Example 2 (specification voglibose 0.2mg: metformin hydrochloride 150mg)

[0021] Make enteric-coated capsules, take 1000 as an example, get metformin hydrochloride 177.51g (according to metformin hydrochloride 150.00g), voglibose 0.20g, starch 109.30g, polyvinylpyrrolidone 13.00g pass through 100 mesh sieve respectively, In a mixer, mix thoroughly, and add an appropriate amount of 85% ethanol solution to make a soft material. Soft materials are granulated through a 20-mesh screen on the granulator. The granules prepared above were dried at 50° C. for 30 min. Then pass through a swinging granulator, and use a 18-mesh sieve to granulate. The content of the mixed granules is determined, and the filling capacity of the enteric-coated capsule shell is determined. After passing the inspection, pack.

Embodiment 3

[0022] Example 3 (specification voglibose 0.1mg: metformin hydrochloride 250mg)

[0023] Make enteric-coated tablets, take 1000 tablets as an example, get metformin hydrochloride 295.85g (calculated as metformin hydrochloride 250.00g), voglibose 0.10g, pregelatinized starch 157.00g, polyvinylpyrrolidone 25.00g, carboxylate 20.00 g of sodium methyl starch was passed through a 100-mesh sieve, put into a blender, mixed evenly, and then an appropriate amount of 85% ethanol solution was added to make a soft material. The soft material is granulated through a 18-mesh screen on a swinging granulator, and the granules are dried at 50°C for 30 minutes. The dry granules are mixed with 2.05 g of magnesium stearate, and the granules are sized through a 16-mesh sieve with a swinging granulator. Content determination, and determine the range of tablet weight, tableting. Or use 80% ethanol to configure the coating solution, coat with a coating pan, and dry.

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Abstract

The invention provides a metformin hydrochloride / voglibose sugar-lowering oral preparation composition and a preparation method thereof. The weight ratio of two main medicines is 8000:1-375:1, preferably 2500:1-625:1. Except for the main medicines, the composition also can further contain commonly used medicine accessories, such as a binder, a filling agent, a disintegrating agent, a lubricant, a flavoring agent, a wetting agent and a flow agent, and the obtained composition can be prepared into tablets, granules, soft and hard capsules, sustained and controlled release preparations, optimum enteric-coated tablets, enteric-coated granules and enteric-coated soft and hard capsules by conventional methods. The composition provided by the invention has action mechanism complementation of the main medicines, multiple target points, good compliance of patients, and the like. The sugar-lowering oral preparation composition can be used for the first-line therapy of type 2 diabetes, or can be used for second-line therapy under the condition that the metformin hydrochloride or sulfonylurea medicines fail to singly and effectively control blood sugar; and the sugar-lowering oral preparation composition is especially suitable for the therapy of diabetic patients suffering from latent autoimmune diabetes in adults (LADA) and hyperinsulinemia.

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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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/133A61K31/155A61P3/10
Inventor 张慧英安英罗钢张玲玲
Owner 北京瑞伊人科技发展有限公司
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