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Pharmaceutical composition containing GKAs (glucokinase activators) and B vitamins and application of pharmaceutical composition

A technology of glucokinase and composition, applied in the field of pharmacy, can solve the problems of neglecting early intervention, and achieve the effects of reducing vascular complications, improving hyperglycemia, and suitable for anti-diabetic drugs

Inactive Publication Date: 2017-03-08
深圳泰乐德医疗有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, antidiabetic drugs on the market focus on correcting the abnormal blood sugar state and metabolic disorders of diabetes, but ignore the early intervention on the composite risk factors that cause diabetic complications (such as diabetic vascular disease)

Method used

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  • Pharmaceutical composition containing GKAs (glucokinase activators) and B vitamins and application of pharmaceutical composition
  • Pharmaceutical composition containing GKAs (glucokinase activators) and B vitamins and application of pharmaceutical composition
  • Pharmaceutical composition containing GKAs (glucokinase activators) and B vitamins and application of pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1. prepare compound recipe TTP399 / 5-methyltetrahydrofolate sheet (1000 pieces amount)

[0030]

[0031]

[0032] Preparation method: Take the prescription quantity 5-MTHF, TTP399 and mix according to the method of equal increase, and set aside; take the prescription quantity of microcrystalline cellulose, low-substituted hydroxypropyl cellulose (L-HPC), sodium starch glycolate, and The mixed powder of the raw material drug is fully mixed, passed through a 80-mesh sieve, and an appropriate amount of 5% povidone 95% ethanol solution is added to make a soft material, granulated with a 20-mesh sieve, dried at 50°C for about 6 hours, and granulated with a 20-mesh sieve to control the particle size. The water content is 2-3%, the dried granules are evenly 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 nee...

Embodiment 2

[0033] Embodiment 2. prepare compound recipe TTP399 / folic acid sheet (1000 pieces amount)

[0034]

[0035] Preparation method: the auxiliary material is a direct pressing auxiliary material, which is dried for later use. Take the prescribed amount of folic acid and microcrystalline cellulose 30g and mix them uniformly according to the method of equal increments to obtain mixed powder 1; Mix evenly to obtain mixed powder 2; mix mixed powder 1 and mixed powder 2 with the prescription amount of glyceryl behenate evenly to obtain the final mixed powder intermediate, test the mixed powder intermediate, and press into 1000 tablets. Pay attention to avoiding light during the preparation process, and the prepared tablets need to be packed in aluminum-plastic blisters and stored away from light. Each of the prepared compound tablets contains 800 mg of TTP399 and 0.4 mg of folic acid.

Embodiment 3

[0036] Example 3. Preparation of Compound TTP399 / Leucovorin / Vitamin B 12 Capsules (1000 capsules)

[0037]

[0038]

[0039] Preparation method: take the prescribed amount of leucovorin and vitamin B 12 , TTP399 are mixed evenly according to the method of equal increase, and then set aside; after mixing evenly with microcrystalline cellulose and sodium carboxymethyl starch, pass through an 80-mesh sieve, add an appropriate amount of 5% povidone 95% ethanol solution, and make a soft material, 50 Dry at ℃ for about 6 hours and pass through a 24-mesh sieve to make granules, control the water content of the granules to 2-3%, mix the dried granules with the prescribed amount of micropowder silica gel, and glyceryl behenate evenly, and test the content of the obtained granule intermediates. After passing the test, put it into a hollow capsule. Pay attention to avoiding light during the preparation process, and the prepared capsules need to be packed in aluminum-plastic blist...

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PUM

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Abstract

The invention relates to pharmaceutical composition containing GKAs (glucokinase activators) and B vitamins. The pharmaceutical composition is prepared from a therapeutic effective dose of one of GKAs as well as medicinal precursors, active metabolites or GKA salts, one or more of a therapeutic effective dose of the B vitamins and pharmaceutically acceptable carriers, wherein the GKAs mainly comprise TTP399, HMS5552, PF-04937319, LY2608204, PF-04991532 and GKM-001; the content of the B vitamins is 0.01-50 mg and adopt folic acid compounds as the first choice. The invention further relates to an application of the composition in preparation of drugs for treating diabetes mellitus and preventing or delaying complications of diabetic angiopathy.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing glucokinase agonist 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. Diabetes is one of the most important non-communicable diseases currently threatening global human health. According to the statistics of the International Diabetes Federation, the number of diabetic patients in the world has reached 370 million in 2011, 80% of which are in developing countries. It is estimated that by 2030 there will be Nearly 550 million people with diabetes. In 2011, a total of 4.6 million people died of diabetes worldwide, and the global medical cost of diabetes reached 465 billion US dollars in that year. Among them, the rapid growth of di...

Claims

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Application Information

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IPC IPC(8): A61K45/06A61P3/10A61P9/10A61P13/12A61P9/14A61P17/02A61P3/00A61P7/00
CPCA61K45/06
Inventor 徐希平刘平张磊于多
Owner 深圳泰乐德医疗有限公司
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