New application of pharmaceutical composition of metformin and 5-methyltetrahydrofolate

A technology of methyltetrahydrofolate and metformin, applied in the field of medicine, can solve the problems of folic acid absorption disorder, neglect of early prevention and treatment of diabetic vascular disease, and reduction of folic acid level

Inactive Publication Date: 2013-08-28
SHENZHEN AUSA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although metformin seldom causes lactic acidosis, its gastrointestinal reactions are very obvious, often leading to gastrointestinal dysfunction and diarrhea. 12 and folic acid malabsorption, resulting in elevated plasma homocysteine ​​levels and decreased folic acid levels
From an

Method used

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  • New application of pharmaceutical composition of metformin and 5-methyltetrahydrofolate
  • New application of pharmaceutical composition of metformin and 5-methyltetrahydrofolate
  • New application of pharmaceutical composition of metformin and 5-methyltetrahydrofolate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～3

[0022] Table 1 Example 1~3 Tablet Prescription Composition

[0023]

[0024] Preparation Process:

[0025] (1) The raw and auxiliary materials are respectively passed through a 100-mesh sieve for subsequent use;

[0026] (2) According to Table 1, the raw and auxiliary materials of the prescription amount are weighed and mixed for subsequent use;

[0027] (3) Add an appropriate amount of binder to make soft materials, granulate with a 24-mesh sieve, and dry at 40-45°C;

[0028] (4) 20 mesh sieve granulation;

[0029] (5) Add an appropriate amount of magnesium stearate to the dry granules, mix them evenly, and compress them into tablets after content determination.

Embodiment 4

[0030] Example 4 Preparation of Compound Metformin 5-MTF Capsules (1000 Capsules)

[0031] formula:

[0032]

[0033]

[0034] Preparation Process:

[0035](1) Pass the raw and auxiliary materials through a 100-mesh sieve for later use; (2) Mix the raw and auxiliary materials according to the above prescription amount and mix them for later use; (3) Add an appropriate amount of binder to make soft materials, granulate with a 24-mesh sieve, Dry at 45°C; (4) sieve through a 20-mesh sieve; (5) add an appropriate amount of magnesium stearate to the dry granules and mix well, and fill the capsules after content determination. Each capsule contains 250mg metformin and 0.2mg 5-MTF.

Embodiment 5

[0036] Example 5 Preparation of compound metformin 5-MTF enteric-coated tablets (quantity of 1000 tablets)

[0037] formula:

[0038]

[0039] Preparation Process:

[0040] (1) Pass the raw and auxiliary materials through a 100-mesh sieve for later use; (2) Weigh metformin, povidone K30, Tween-80 and sodium hydroxide in absolute ethanol as the adhesive solution according to the above; ( 3) Weigh microcrystalline cellulose (model pH101) and croscarmellose sodium according to the above, mix them evenly, add binder, and dry at 40-45°C; (4) granulate with 24-mesh sieve; (5) Dry granules Add an appropriate amount of magnesium stearate and talcum powder and mix evenly. After the content is determined, the tablet is pressed, and then the isolation layer coating and the enteric coating are performed sequentially. Each tablet contains 250mg of metformin and 0.2mg of 5-MTF.

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PUM

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Abstract

The invention relates to new application of a pharmaceutical composition containing officinal dose of metformin and 5-methyltetrahydrofolate for preventing and treating complications of diabetic microangiopathy. The pharmaceutical composition is characterized in that the dose of the metformin is 250-1000 mg, and the dose of the 5-methyltetrahydrofolate is 0.4-1.6 mg. The application has the advantages that the pharmaceutical composition has obvious beneficial effects of preventing and treating the diabetic microangiopathy on the basis that the blood sugar is effectively lowered, so that the pharmaceutical composition is beneficial for preventing or delaying diabetic complications and lowering the disability rate and the fatality rate.

Description

technical field [0001] The invention relates to the use of a pharmaceutical composition composed of metformin and 5-methyltetrahydrofolate in medicinal doses for preparing and preventing complications of diabetic microangiopathy. The invention belongs to the field of medicine. Background technique [0002] Diabetes mellitus is a common endocrine and metabolic disease characterized by chronic hyperglycemia accompanied by disturbances in sugar, fat and protein metabolism caused by insufficient insulin secretion and / or action defects. According to the survey, the prevalence of diabetes in my country is as high as 9.7%, and it is estimated that there are about 92.4 million people with diabetes [Yang W, et al. Prevalence of diabetes among men and women in China. N Engl JMed. 2010; 362: 1090-1101]. Visible, diabetes is a serious public health problem. [0003] Diabetes can occur at any age. As the course of the disease prolongs, it is easy to be complicated by systemic nerve, mi...

Claims

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Application Information

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IPC IPC(8): A61K31/519A61P3/10A61P13/12A61P9/10A61K31/155
Inventor 张磊陈光亮徐希平徐欣田敏卿秦献辉
Owner SHENZHEN AUSA PHARMA
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