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Medicine composition for treatment of diabetes, and preparation method and application thereof

A composition and diabetes technology, applied in the direction of drug combination, pharmaceutical formula, medical preparations containing active ingredients, etc., can solve the problems of prevention or delay of diabetes complications without evidence-based medicine, renal function damage, renal disease aggravation, etc., to achieve Control blood sugar production rate, increase compliance, good synergistic effect

Inactive Publication Date: 2019-03-29
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, SGLT2 inhibitors also have some "inherent" deficiencies: compared with traditional hypoglycemic drugs, SGLT2 inhibitors have no evidence-based medicine in preventing or delaying diabetic complications, and whether it leads to long-term diabetes is unfavorable to the kidneys Effects (eg, urinary tract infection, renal impairment, or exacerbation of renal disease), still to be investigated
[0008] Since 2012, a total of 6 SGLT2 inhibitors have been launched in the European Union, the United States and Japan, and these drugs are still in the approval stage in China

Method used

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  • Medicine composition for treatment of diabetes, and preparation method and application thereof
  • Medicine composition for treatment of diabetes, and preparation method and application thereof
  • Medicine composition for treatment of diabetes, and preparation method and application thereof

Examples

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Comparison scheme
Effect test

Embodiment 1

[0077] This example is used to illustrate the pharmaceutical composition of tepagliflozin and metformin hydrochloride of the present invention and its preparation method, and the specific details are as follows: specification 2.5mg / 250mg

[0078]

[0079] Preparation Process:

[0080] Pass the prescribed amount of metformin hydrochloride and polyvinylpyrrolidone through an 80-mesh sieve, and then put them into the silo of the wet granulator, and dry-mix at a speed (stirring 450rpm, shearing 470rpm) for 5-10 minutes. Add an appropriate amount of 50% ethanol water, and wet the granules at a speed (stirring 450 rpm, shearing 470 rpm) for 3 to 5 minutes. The wet granules are granulated through a 20-mesh sieve with a swing granulator. After the granulation, the wet granules are poured into the Glatt fluidized bed machine, the air inlet temperature is 50-60°C, the material temperature is about 50°C, and the drying time is about 8-14 minutes. Control moisture ≤ 3.5% is the dryin...

Embodiment 2

[0086] This example is used to illustrate the pharmaceutical composition of tepagliflozin and metformin hydrochloride of the present invention and its preparation method, and the specific details are as follows: specification 5mg / 250mg

[0087]

[0088] Preparation Process:

[0089] Pass the prescribed amount of metformin hydrochloride and hypromellose through an 80-mesh sieve, then put them into the silo of the wet granulator, and dry mix at a speed (stirring 450rpm, shearing 470rpm) for 5-10 minutes. Add an appropriate amount of 30% ethanol water, and wet the granules at a speed (stirring 450 rpm, shearing 470 rpm) for 3 to 5 minutes. The wet granules are granulated through a 20-mesh sieve with a swing granulator. After the granulation, the wet granules are poured into the Glatt fluidized bed machine, the air inlet temperature is 50-60°C, the material temperature is about 50°C, and the drying time is about 8-14 minutes. Control moisture ≤ 3.5% is the drying end point. Th...

Embodiment 3

[0095] This example is used to illustrate the pharmaceutical composition of tepagliflozin and metformin hydrochloride of the present invention and its preparation method, specifically detailed as follows: specification 5mg / 500mg

[0096]

[0097] Preparation Process:

[0098] Pass the prescribed amount of metformin hydrochloride and polyvinylpyrrolidone through an 80-mesh sieve, and then put them into the silo of the wet granulator, and dry-mix at a speed (stirring 480rpm, shearing 500rpm) for 5-10 minutes. Add an appropriate amount of 50% ethanol water, and wet the granules at a speed (stirring 480 rpm, shearing 500 rpm) for 3 to 5 minutes. The wet granules are granulated through a 20-mesh sieve with a swing granulator. After the granulation, the wet granules are poured into the Glatt fluidized bed machine, the air inlet temperature is 50-60°C, the material temperature is about 50°C, and the drying time is about 8-14 minutes. Control moisture ≤ 3.5% is the drying end poi...

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Abstract

The invention relates to a medicine composition for treatment of diabetes, which includes dapagliflozin and metformin hydrochloride according to mass ratio of 1:50 to 1:200. The invention also provides a preparation method and an application of the medicine composition of dapagliflozin and metformin hydrochloride. The medicine composition is composed of, in specific ratio, the SGLT2 inhibitor dapagliflozin and the metformin hydrochloride, so that the medicine composition can control the generation rate of blood glucose more effectively in order to synergistically treat the diabetes. The medicine composition brings convenience to patients and improves compliance. In the method, by control the particle sizes of both the metformin hydrochloride particles and the dapagliflozin, mixing uniformity of the two active components is guaranteed, and flowability and tabletability of the particles are ensured. The method is suitable for industrial large-scale production. The medicine composition can be used for treatment on the diabetes type II.

Description

technical field [0001] The invention relates to the pharmaceutical field related to hypoglycemic preparations, in particular to a pharmaceutical composition for treating diabetes and its preparation method and application. Background technique [0002] The incidence of diabetes continues to rise and has become one of the five diseases with the highest morbidity and mortality in the world, especially in developing countries such as China, the Indochina subcontinent and Africa. Diabetes can be divided into Type I, insulin-dependent diabetes mellitus (IDDM), and Type II, non-insulin-dependent diabetes mellitus (NIDDM). Vascular complications often occur with the progression of diabetes, including macrovascular disease and microvascular disease, leading to chronic progressive damage to the heart, brain, kidney, eyes and other organs. The harm of diabetes mainly comes from these complications. According to the report of the Diabetes Branch of the Chinese Medical Association, th...

Claims

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Application Information

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IPC IPC(8): A61K31/351A61K31/155A61P3/10
CPCA61K31/155A61K31/351A61K2300/00
Inventor 任晓文徐为人赵桂龙王玉丽曹光汤立达邹美香孟策
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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