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Pharmaceutical composition containing glinides and B vitamins and use thereof

A composition, the technology of nateglinide, applied in the field of pharmacy, can solve the problems of immune system imbalance, prevention or delay of diabetes complications, lack of mechanism advantages, weight gain, etc., to improve hyperglycemia, suitable anti-diabetic drugs, reduce blood vessels The effect of the occurrence of complications

Active Publication Date: 2016-09-14
SHENZHEN AUSA PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, glinides also have some shortcomings: compared with traditional hypoglycemic drugs, glinides have a shorter history of clinical application, lack of mechanistic advantages in preventing or delaying diabetic complications, and lack of evidence-based medicine Research evidence; Glinides also have some adverse reactions, common ones are hypoglycemia and weight gain, and less common ones include immune system disorders, hyperglycemia, etc.
At present, most of the antidiabetic drugs on the market focus on correcting the abnormal state of blood sugar and metabolic disorders of diabetes, while ignoring the early and simultaneous intervention of the composite risk factors that cause diabetic complications (such as diabetic vascular disease)

Method used

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  • Pharmaceutical composition containing glinides and B vitamins and use thereof
  • Pharmaceutical composition containing glinides and B vitamins and use thereof
  • Pharmaceutical composition containing glinides and B vitamins and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1. Preparation of Compound Repaglinide / Folic Acid Tablets (1000 Tablets)

[0031]

[0032] Preparation method: Take the prescribed amount of folic acid and repaglinide and mix them uniformly according to the method of equal increase, and set aside; take the prescribed amount of microcrystalline cellulose, low-substituted hydroxypropyl cellulose (L-HPC), sodium carboxymethyl starch , fully mixed with the mixed powder of the raw material medicine, passed through a 80-mesh sieve, added an appropriate amount of 5% povidone 95% ethanol solution to make a soft material, granulated with a 20-mesh sieve, dried at 50°C for about 6 hours, granulated with a 20-mesh sieve, and controlled The water content of the granules is 2-3%, the dried granules are uniformly mixed with the prescribed amount of magnesium stearate, the intermediate is tested, and pressed into 1000 tablets. Pay attention to avoiding light during the preparation process, and the prepared tablets need to ...

Embodiment 2

[0033] Example 2. Preparation of Compound Nateglinide / Folic Acid Tablets (1000 Tablets)

[0034]

[0035] Preparation method: Take the prescribed amount of folic acid and nateglinide and mix them uniformly according to the method of equal increase, and set aside; weigh the prescribed amount of microcrystalline cellulose, lactose, crospovidone, and sodium carboxymethyl starch, and mix them with the raw materials Mix the powder well, pass through a 80 mesh sieve, add an appropriate amount of 10% polyvinylpyrrolidone solution to make a soft material, granulate with a 20 mesh sieve, dry at 50°C for about 6 hours, granulate with a 20 mesh sieve, and control the water content of the granules to 2-3 %, the dried granules are evenly mixed with the prescribed amount of glyceryl behenate and magnesium stearate, and the intermediates are tested, and pressed into 1000 tablets. Pay attention to avoiding light during the preparation process, and the prepared tablets need to be packed in ...

Embodiment 3

[0036] Example 3. Preparation of compound mitiglinide / 5-methyltetrahydrofolic acid tablets (1000 pieces)

[0037]

[0038] Preparation method: the auxiliary material is a direct pressing auxiliary material, which is dried for later use. The 5-methyltetrahydrofolate and microcrystalline cellulose of prescription quantity are mixed uniformly according to the method of equal increase to obtain mixed powder intermediate 1; microcrystalline cellulose, lactose and sodium carboxymethyl starch of remaining prescription quantity are weighed, Mix thoroughly with mitiglinide by the method of equal increments to obtain the mixed powder intermediate 2; mix the powder mixed intermediate 1 and the powder mixed intermediate 2 with the prescription amount of magnesium stearate according to the equal increment method to obtain The final mixed powder intermediate is tested and pressed into 1000 tablets. Pay attention to avoiding light during the preparation process, and the prepared tablets ...

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PUM

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Abstract

The present invention relates to a pharmaceutical composition containing glinides hypoglycemic drugs (referred to as glinides) and B vitamins. One of the class, one or several B vitamins in a therapeutically effective amount, and a pharmaceutically acceptable carrier; wherein, the meglitinide mainly includes repaglinide, nateglinide, miglinide Chennai, the content is 0.5-120 mg, and the content of B vitamins is 0.01-50 mg. The invention also relates to the use of the composition in the preparation of medicines for treating diabetes. The medicine made from the pharmaceutical composition provided by the invention has a more significant beneficial effect of preventing or delaying complications of diabetic vascular disease on the basis of effectively lowering blood sugar. In addition, the present invention can also make it convenient for patients to take medicine and increase compliance.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing a glinide insulin secretion-stimulating agent (glinide for short) and B vitamins, belonging to the field of pharmacy. 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 epidemiological surveys, the prevalence of diabetes in my country is as high as 9.7%, and it is estimated that the total number of adult diabetic patients in the country is 92.4 million [Yang W, et al. Prevalence of diabetes among men and women in China. N Engl J Med.2010; -1101]. In addition, according to the statistics of the International Diabetes Federation (IDF), there were 285 million people with diabetes worldwide in 2010, and it is estimated that nearly 500 million people worldwide will suffer fro...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K45/06A61K31/519A61K31/451A61K31/714A61P3/10A61P9/10A61P17/02A61P9/00A61P13/12A61K31/198A61K31/4035
Inventor 徐希平张磊王存芳王滨燕
Owner SHENZHEN AUSA PHARM CO LTD
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