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Pharmaceutical composition containing SGLT2 (sodium-glucose type 2 transporter) inhibitors and group B vitamins as well as application thereof

A technology of B vitamins and composition, applied in the field of pharmacy, can solve the problems of renal function damage, neglect of early stage, synchronous intervention, prevention or delay of diabetic complications without evidence-based medicine, etc., to reduce vascular complications and improve hyperglycemia Effect

Active Publication Date: 2014-04-16
SHENZHEN AUSA PHARM CO LTD +1
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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 medical evidence in preventing or delaying diabetic complications, and whether it leads to long-term diabetes that is unfavorable to the kidneys Effects (eg, urinary tract infection, renal impairment, or exacerbation of renal disease), still to be investigated
Most of the antidiabetic drugs currently on the market focus on correcting the abnormal blood sugar state 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 SGLT2 (sodium-glucose type 2 transporter) inhibitors and group B vitamins as well as application thereof
  • Pharmaceutical composition containing SGLT2 (sodium-glucose type 2 transporter) inhibitors and group B vitamins as well as application thereof
  • Pharmaceutical composition containing SGLT2 (sodium-glucose type 2 transporter) inhibitors and group B vitamins as well as application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1. Preparation of Compound Dapagliflozin / 5-Methyltetrahydrofolate Tablets (1000 Tablets)

[0032] formula:

[0033]

[0034]

[0035] Preparation method: take the prescribed amount of 5-methyltetrahydrofolate and dapagliflozin and mix them uniformly according to the method of equal increase, and set aside; weigh the prescribed amount of microcrystalline cellulose and low-substituted hydroxypropyl cellulose (L-HPC) , Sodium carboxymethyl starch, fully mixed with the raw material drug powder, 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, 20 mesh Sieve the granules, control the water content of the granules to 2-3%, mix the dried granules with the prescribed amount of magnesium stearate evenly, test the intermediates, and press them into 1000 tablets. Pay attention to avoiding light during the preparation process, and t...

Embodiment 2

[0036] Example 2. Preparation of Compound Repagliflozin / Folic Acid Tablets (1000 Tablets)

[0037] formula:

[0038]

[0039] Preparation method: the auxiliary material is a direct pressing auxiliary material, which is dried for later use. Take 30 g of folic acid and microcrystalline cellulose in the prescribed amount and mix them uniformly according to the method of equal increments to obtain mixed powder 1; Mix well by incremental method to obtain mixed powder 2; mix mixed powder 1 and mixed powder 2 with the prescribed 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 75 mg of repaggliflozin and 0.6 mg of folic acid.

Embodiment 3

[0040] Example 3. Preparation of Compound Seragliflozin / Leucovorin / Vitamin B 12 Capsules (1000 capsules)

[0041] formula:

[0042]

[0043]

[0044] Preparation method: take the prescribed amount of leucovorin and vitamin B 12 , Shegegliflozin is mixed uniformly according to the method of equal increase, and then set aside; then mixed with microcrystalline cellulose and sodium carboxymethyl starch, passed through an 80-mesh sieve, added an appropriate amount of 5% povidone 95% ethanol solution, and made soft material, dried at 50°C for about 6 hours, passed through a 24-mesh sieve to make granules, and the water content of the granules was controlled to be 2-3%. Content detection, after passing the detection, put into hollow capsules to get final product. Pay attention to avoiding light during the preparation process, and the prepared capsules need to be packed in aluminum-plastic blisters and stored away from light. Each capsule contains 50mg of sergegliflozin, 0.6...

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PUM

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Abstract

The invention relates to a pharmaceutical composition containing SGLT2 (sodium-glucose type 2 transporter) inhibitors and group B vitamins. The pharmaceutical composition consists of SGLT2 inhibitors in therapeutically effective amount and one of medicinal precursors, active metabolites or salts thereof, one or more in group B vitamins in therapeutically effective amount, and pharmaceutically acceptable carriers, wherein the SGLT2 inhibitors mainly comprise dapagliflozin, remogliflozin and sergliflozin and have the content of 2.5-500mg, and the content of the group B vitamins is 0.01-50mg. The invention also relates to application of the composition in preparation of medicines for treating diabetes. The medicine prepared by the pharmaceutical composition provided by the invention has the beneficial effect of obviously preventing or delaying complication of diabetic angiopathies on the basis of effectively reducing blood sugar. In addition, the pharmaceutical composition can be conveniently taken by a patient, and the compliance is improved.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing a sodium-glucose co-transporter2 (SGLT2) inhibitor 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; 362 : 1090-1101]. 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 from dia...

Claims

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Application Information

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IPC IPC(8): A61K45/06A61P3/10A61P9/10A61P17/02A61P13/12
Inventor 徐希平陈光亮张磊王存芳
Owner SHENZHEN AUSA PHARM CO LTD
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