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Combined drug for treating diabetes mellitus and complications and pharmaceutical composition of combined drug

A composition and diabetes technology, applied in drug combinations, urinary system diseases, active ingredients of heterocyclic compounds, etc., can solve problems such as effective population and long-term curative effect limitations, complication prevention and control effect differences, etc.

Active Publication Date: 2020-07-24
CHENGDU CHIPSCREEN PHARM LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are at least 8 categories of oral or injectable therapeutic drugs other than insulin according to the therapeutic mechanism, but the effective population and long-term efficacy of existing drug monotherapy have limitations
[0004] In addition, diabetic patients have a higher risk of complications such as cardiovascular and cerebrovascular, kidney and liver compared with other populations, and the existing therapeutic drugs have different effects on the prevention and control of these complications in addition to controlling blood sugar

Method used

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  • Combined drug for treating diabetes mellitus and complications and pharmaceutical composition of combined drug
  • Combined drug for treating diabetes mellitus and complications and pharmaceutical composition of combined drug
  • Combined drug for treating diabetes mellitus and complications and pharmaceutical composition of combined drug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Example 1 Comparing the effect of siglitastat sodium combined with empagliflozin on body weight and blood sugar compared with single treatment

[0061] Experimental design: In diabetic mice, siglitastat sodium, empagliflozin or the combination of the two were orally administered, and the effects of single drug and drug combination on the body weight and blood sugar of the mice were investigated.

[0062] Test process: 6-week-old db / db male mice were orally administered 100 microliters of vehicle (0.1% sodium carboxymethylcellulose), 10 mg / kg siglitastat sodium, 3 mg / kg Engel Liejing or the same dose of siglitastat sodium and empaglitazine orally at the same time. Wild-type C57BLKS / Jnju mice were used as normal control mice (administered with vehicle). The dosing cycle was 14 days, and the animals were dissected on the 15th day. From the beginning of drug administration, mice were weighed every 3 days and fasting blood glucose was measured (fasting for 4-6 hours). Tes...

Embodiment 2

[0064] Example 2 Comparing the effect of siglitastat sodium combined with dapagliflozin on body weight and blood sugar compared with single treatment

[0065] Experimental design: In diabetic mice, siglitastat sodium, dapagliflozin or the combination of the two were orally administered, and the effects of the single drug and drug combination on the body weight and blood sugar of the mice were investigated.

[0066] Test process: 6-week-old db / db male mice were orally administered 100 microliters of vehicle (0.1% sodium carboxymethylcellulose), 10 mg / kg siglitastat sodium, 1.5 mg / kg Dagretal once a day according to their body weight Liejing or siglitastat sodium and dapaglitazine at the same dose orally at the same time. Wild-type C57BLKS / Jnju mice were used as normal control mice (administered with vehicle). The dosing cycle was 14 days, and the animals were dissected on the 15th day. From the beginning of drug administration, mice were weighed every 3 days and fasting blood...

Embodiment 3

[0068] Example 3 Effect of siglitastat sodium combined with empagliflozin on blood lipids

[0069] Experimental design: In diabetic mice, siglitastat sodium, empagliflozin or the combination of the two were administered orally, and the effects of single drug and drug combination on total cholesterol (TC) and triglyceride (TG) in serum of mice were investigated.

[0070] Test process: 6-week-old db / db male mice were orally administered 100 microliters of vehicle (0.1% sodium carboxymethylcellulose), 10 mg / kg siglitastat sodium, 3 mg / kg Engel Liejing or the same dose of siglitastat sodium and empaglitazine orally at the same time. Wild-type C57BLKS / Jnju mice were used as normal control mice (administered with vehicle). The dosing cycle was 14 days, and the animals were dissected on the 15th day. Whole blood was collected, the serum was collected by centrifugation, and the TC and TG of the serum were measured by a biochemical analyzer. Test results such as image 3 shown.

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PUM

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Abstract

The invention belongs to the technical field of biology, and specifically relates to a combined drug for treating diabetes mellitus and complications and a pharmaceutical composition of the combined drug. The invention discloses combined use of components (i): a compound represented by a general formula (I), pharmaceutical salt of the compound and isomers of the compound and the pharmaceutical salt and a component (ii): an SGLT2 inhibitor in preparation of drugs for preventing and / or treating the diabetes mellitus and / or the complications of the diabetes mellitus, and further discloses the pharmaceutical composition containing the components (i) and the component (ii). The combined drug is capable of synergetically reducing blood sugar of db / db diabetic mice, generating an unexpected synergetic effect, improving blood lipid indexes, particularly improving content of triglyceride in serum and further generating a combined effect in aspects of control of body weight and protection of blood lipid, blood pressure, livers and kidneys, so that more benefits are brought to prevention and / or treatment of the diabetes mellitus and the complications including cardiovascular and cerebrovascular diseases, kidney diseases and hepatic diseases.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to combined medicine and its pharmaceutical composition for the treatment of diabetes and its complications. Background technique [0002] Diabetes is a disease caused by a variety of genetic disorders, and it currently plagues a considerable part of the world's population. It is mainly divided into two types: (1) type 1 diabetes or insulin-dependent diabetes mellitus (IDDM), in which patients secrete little or no insulin; (2) type 2 diabetes or non-insulin-dependent diabetes mellitus (NIDDM). The core problem of patients with type 2 diabetes is insulin resistance, that is, peripheral tissues such as muscle, liver and adipose tissue have obstacles to the absorption and metabolism of blood sugar stimulated by insulin, which in turn increases the burden of insulin secretion by the islets, and eventually leads to the progressive decline or even loss of islet function. . 90% of diabetic p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K31/403A61K31/381A61K31/7048A61K31/382A61K31/35A61K31/401A61P3/10A61P9/00A61P13/12A61P1/16
CPCA61K45/06A61K31/403A61K31/381A61K31/7048A61K31/382A61K31/35A61K31/401A61P3/10A61P9/00A61P13/12A61P1/16A61K2300/00A61K31/7042A61K31/70A61P3/06A61K31/7034A61K31/404
Inventor 黄圣健鲁先平潘德思廖国强赵一如
Owner CHENGDU CHIPSCREEN PHARM LTD
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