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New use of dimethyldiguanide/folic acid/vitamin B12 pharmaceutical composition

A technology of metformin and its composition, applied in the field of medicine, can solve problems such as different uses, chemical impossibility, and lack of scientific principles, and achieve the effects of reducing levels, increasing anaerobic glycolysis, and increasing sensitivity

Active Publication Date: 2015-08-19
SHENZHEN AUSA PHARM CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] After searching, it was found that the patent "Pharmaceutical preparation for preventing or treating metabolic syndrome" (patent number: 200510082929.4) involves the composition of biguanides and B vitamins, but the purpose is to treat metabolic syndrome, which is different from the use of this patent; the patent " Metformin folate and its preparation method" (Patent No.: 200610149044.6) involves connecting folic acid and metformin into a compound by chemical reaction, which is completely impossible chemically, lacks the most basic scientific principles, and the compound does not involve Vitamin B 12 , which is different from this patent; the patent "contains metformin hydrochloride and vitamin B 12 Combination Drugs" (Patent No.: 200910310219.0) does not involve folic acid, and is limited to the treatment of megaloblastic anemia and aplastic anemia, which is completely different from the use of this patent

Method used

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  • New use of dimethyldiguanide/folic acid/vitamin B12 pharmaceutical composition
  • New use of dimethyldiguanide/folic acid/vitamin B12 pharmaceutical composition
  • New use of dimethyldiguanide/folic acid/vitamin B12 pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1 Preparation of Compound Metformin / Folic Acid / Vitamin B 12 Tablets (1000 pieces)

[0033]

[0034] Preparation method: pass all auxiliary materials through a 80-mesh sieve, and crush the metformin hydrochloride crude drug through a 100-mesh sieve for later use. Take 0.4g folic acid, 5mg vitamin B 12 , mixed uniformly according to the equal increment method, mixed with sodium carboxymethyl starch and microcrystalline cellulose to pass through an 80-mesh sieve, then mixed with 500g of metformin hydrochloride, added starch, and mixed evenly with low-substituted hydroxypropyl cellulose, and mixed with 5% polyvinyl chloride Ketone K30-95% ethanol solution to make soft material, granulate with 20 mesh sieve, dry at 60°C for about 2 hours, granulate with 20 mesh sieve, control the water content of the granules to 2-3%, mix the dried granules with stearic acid The magnesium is mixed evenly, the semi-finished product is tested, the content is determined, and it i...

Embodiment 2

[0035] Example 2 Preparation of Compound Metformin / Folic Acid / Vitamin B 12 Double-layer sustained-release tablets (quantity of 1000 tablets)

[0036] formula:

[0037] Metformin extended-release layer:

[0038]

[0039] Folic Acid / B Vitamins 12 Floor:

[0040]

[0041] Preparation method: (1) Metformin slow-release layer: Mix metformin hydrochloride, hypromellose and stearyl alcohol crushed and passed through an 80-mesh sieve evenly according to the prescription amount, add 5% ethyl cellulose alcohol solution to make a soft material, Granulate with a 20-mesh sieve, dry at 60°C for 2 hours, granulate with a 20-mesh sieve, and then add magnesium stearate for detection. (2) B vitamins folic acid 12 Layer: Take 0.4g folic acid, 10mg vitamin B 12 , mixed according to the method of equal increase, then added microcrystalline cellulose and mixed, passed through a 80-mesh sieve, added starch, sodium starch glycolate and low-substituted hydroxypropyl cellulose respective...

Embodiment 3

[0042] Example 3 Preparation of Compound Metformin / Folic Acid / Vitamin B 12 Sustained-release tablets (quantity of 1000 tablets)

[0043] Metformin Hydrochloride Extended Release Layer:

[0044]

[0045] Folic Acid / B Vitamins 12 Immediate Release Coating:

[0046]

[0047] Preparation:

[0048] Sustained-release layer: Mix metformin hydrochloride crushed and passed through a 100-mesh sieve with lactose, glyceryl behenate and the prescribed amount, then add hypromellose and mix, add 10% povidone K30 ethanol solution to make soft material , granulate with 18-mesh sieve, dry at 60°C for 2 hours, granulate with 18-mesh sieve, then add magnesium stearate, test, and tablet.

[0049] Immediate release layer: Feed amount of folic acid (folic acid is fed in excess of 30%), vitamin B 12 (Vitamin B 12 According to 35% excess feeding), add 570g of purified water and stir evenly, then add 30g of Opadry film coating premix and stir, and continue stirring for 45min after the O...

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PUM

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Abstract

The invention relates to a pharmaceutical composition containing a pharmaceutical dose of dimethyldiguanide, folic acid, vitamin B12 and a pharmaceutical carrier or an excipient, belonging to the field of pharmacy. According to the pharmaceutical composition, a harmful result caused by adverse reaction of gastrointestinal tracts when dimethyldiguanide is singly used can be overcome; meanwhile, the pharmaceutical composition has the purpose of preventing, delaying or treating hyperhomocysteinemia, the effect is superior to the effects of existing similar pharmaceutical compositions, and the economic and practical pharmaceutical composition is provided for diabetic patients. The pharmaceutical composition further has the advantage that the medication compliance of the patients is improved.

Description

technical field [0001] The invention relates to a medicine containing metformin, folic acid and vitamin B 12 The pharmaceutical composition of the invention is used in the preparation of a medicine suitable for type 2 diabetes patients to prevent or relieve hyperhomocysteinemia. 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 in China [Yang W, et al. Prevalence of diabetes among men and women in China. N Engl J Med. 2010; 362: 1090-1101 】. Diabetes can occur at any age. As the course of the disease prolongs, it is easy to be complicated by systemic nerve, micr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/714A61P3/10A61P3/00A61P7/00A61K31/155A61K31/519
Inventor 徐希平张磊陈光亮王滨燕
Owner SHENZHEN AUSA PHARM CO LTD
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