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Pharmaceutical composition for treating and/or preventing insulin dependent diabetes mellitus and application thereof

A composition and technology for diabetes, applied in the field of compositions for the treatment and/or prevention of type I diabetes, capable of solving the problems of inhibiting organ failure, unreasonable curative effect, toxic and side effects, etc., and achieving the effect of inhibiting the occurrence of type I diabetes

Active Publication Date: 2013-10-30
ADVACCINE SUZHOU BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because these drugs are non-specific immunosuppressants, the curative effect is unreasonable, and the use of large doses of immunosuppressants has its toxic and side effects. lead to suppressed organ failure risk

Method used

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  • Pharmaceutical composition for treating and/or preventing insulin dependent diabetes mellitus and application thereof
  • Pharmaceutical composition for treating and/or preventing insulin dependent diabetes mellitus and application thereof
  • Pharmaceutical composition for treating and/or preventing insulin dependent diabetes mellitus and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] Example 1. Drug dose-effect experiment in NOD mice

[0083] 1. NOD mouse immunization

[0084] 1. Immune a pharmaceutical composition composed of human insulin (Novolin R) and dexamethasone

[0085] The NOD mice were equally divided into 4 groups, 3 in each group. On days 1, 4, and 7, the pharmaceutical composition was injected subcutaneously in the abdomen: each mouse in group 1 (group 10+10) was injected with PBS containing 10 micrograms of human insulin (Novolin R) mixed with 10 micrograms of dexamethasone 100 μl, the second group (100+100 group) each injected 100 μg insulin mixed with 100 μg dexamethasone PBS 100 μl, the third group (500+100 group) each injected 500 μg insulin mixed separately 100 micrograms of dexamethasone in 100 microliters of PBS.

[0086] 2. Immune a pharmaceutical composition composed of human insulin epitope polypeptide B9-23 and dexamethasone

[0087] The NOD mice were equally divided into 4 groups, 3 in each group. On days 1, 4, and 7, the pharma...

Embodiment 2

[0102] Example 2: Therapeutic effect test of immediate type I diabetes in NOD mice

[0103] 1. Pathogenesis and immunity of NOD mice

[0104] After the drug dose-effect relationship was determined in Example 1, NOD mice were used to induce type I diabetes, and after it was judged to be hyperglycemia (>12mmol), intraperitoneal injection of the drug composition (comprised of human insulin (Novoline R) and dexamethasone) was performed. Composition of the pharmaceutical composition). The specific operations are as follows:

[0105] 18 NOD mice were intraperitoneally injected with streptozotocin (STZ) (Sigma Aldrige, S0130) 40 mg / kg for 5 consecutive days to induce type I diabetes. Determined as hyperglycemia (>12m mol), (the first injection of STZ is recorded as the first day, about 10 days later, the immediate type I diabetes model of NOD mice is obtained) and then divided into 3 groups, each with 6 mice, the first No treatment was given to the group (group 10+10), the second group (...

Embodiment 3

[0120] Example 3 The treatment effect test of long-term type I diabetes in NOD mice

[0121] After Example 2 proved that the pharmaceutical composition (a pharmaceutical composition composed of human insulin (Novolin R) and dexamethasone) has a therapeutic effect on immediate type I diabetes, the treatment evaluation of the long-term type I diabetes was performed ,details as follows:

[0122] 1. Pathogenesis and immunity of NOD mice

[0123] 16 NOD mice were injected with STZ 40mg / kg intraperitoneally for 5 consecutive days to induce type I diabetes. Two months after the onset of the disease, they were injected. Divide into 2 groups, 8 animals in each group, the first group (the onset group) will not be treated, and the second group (treatment group) will be injected with 10 micrograms of human insulin mixed with 10 micrograms of dexamethasone in 100 microliters of PBS as treatment group. A subcutaneous injection in the abdomen was given on the 1, 4, and 7 days each, which was a ...

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PUM

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Abstract

The present invention provides a composition for treating and / or preventing type I diabetes and an application thereof. The active ingredient of the composition is 1.) or 2.) or 3.), as follows: 1.) a mixture of a type I diabetes protein antigen and an immunosuppressor, 2.) a mixture of a type I diabetes protein antigenic epitope polypeptide and an immunosuppressor, 3.) a mixture of a type I diabetes protein antigen, a type I diabetes protein antigenic epitope polypeptide, and an immunosuppressor; the type I diabetes protein antigen is at least one of insulin, glutamic acid decarboxylase, and islet amyloid polypeptide, and the immunosuppressor is at least one of dexamethasone, cyclosporine A, tacrolimus, mycophenolate mofetil, azathioprine, prednisone, early prednisolone, anti-CD4 monoclonal antibody, and anti-CD3 monoclonal antibody.

Description

Technical field [0001] The present invention relates to a composition for treating and / or preventing type I diabetes and its application. Background technique [0002] Experts from the World Health Organization (WHO) predict that diabetes will be a major health crisis in the 21st century, especially in Asia, where its threat is more serious than bird flu and AIDS. WHO estimates that the number of diabetic patients worldwide will increase to 200 million by 2010, and it will exceed 330 million by 2025. From the current situation analysis, in the next 10 years, 60% of all cases in the world will appear in Asia. According to reports, the Western Pacific (including China) and Southeast Asia (including India) are the regions with the most diabetes patients in the world. Of the five countries with the most diabetes patients in the world, four are in Asia. [0003] In the process of my country’s development towards a well-off society, people’s intake of fat and carbohydrates has not bee...

Claims

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Application Information

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IPC IPC(8): A61K45/06A61P3/10A61P37/02
CPCA61K39/395A61K31/52A61K38/16A61K38/28A61K38/13A61K39/39541A61K31/573A61K31/436A61K38/51A61K39/0008A61K39/3955C12Y401/01015A61K2300/00A61K38/22C07K16/2815C07K2317/76A61P37/02A61P37/06A61P3/10A61K2039/505
Inventor 王宾郑国兴耿爽王意忠俞庆龄
Owner ADVACCINE SUZHOU BIOPHARMACEUTICALS CO LTD
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