Pharmaceutical composition containing GLP-1 analogue and DPP-4 inhibitor and preparation method thereof

A GLP-1, DPP-4 technology, applied in the direction of drug combination, medical preparations containing active ingredients, drug delivery, etc., can solve the problems of elevated HbA1c, hypoglycemia, complicated patients, etc. Tolerability, the effect of reducing side effects

Inactive Publication Date: 2015-04-29
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For many patients, these regimens do not adequately control glycemia during long-term treatment, resulting in the requirement for combination therapy within a few years of diagnosis
However, co-prescription of two or more oral antidiabetic drugs can create complex and difficult-to-follow regimens for many patients
[0023] The current diabetes treatment drugs mainly have the following problems: poor curative effect, HbA1c rises with the progress of the disease; hypoglycemia; patients with high cardiovascular risk

Method used

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  • Pharmaceutical composition containing GLP-1 analogue and DPP-4 inhibitor and preparation method thereof
  • Pharmaceutical composition containing GLP-1 analogue and DPP-4 inhibitor and preparation method thereof
  • Pharmaceutical composition containing GLP-1 analogue and DPP-4 inhibitor and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Example 1: Preparation of liraglutide and sitagliptin injection

[0046] 1. Injection formula

[0047]

[0048] 2. Preparation process

[0049] Weigh 300mg of chlorobutanol and 1500mg of mannitol in a 10,000-class clean room and a 100-class ultra-clean workbench in a clean room, add 150mL of water for injection and stir to dissolve, then add to the batching tank; weigh 30mg of Liralu Peptide, 3000mg sitagliptin phosphate (calculated as sitagliptin), add 50mL water for injection to dissolve, add to the solution in the above liquid mixing tank, stir and dissolve until the solution is clear, add 0.1N sodium hydroxide, adjust the pH of the solution to 8.0, add the remaining amount of injection water to make up the volume, filter and sterilize with a 0.22 μm filter membrane; dispense into injection pens, each 3ml, 100 in total.

Embodiment 2

[0050] Example 2: Preparation of liraglutide and sitagliptin injection

[0051] 1. Injection formula

[0052]

[0053] 2. Preparation process

[0054] Weigh 3000mg of chlorobutanol and 2500mg of propylene glycol in a 10,000-class clean room and a 100-class ultra-clean workbench in a clean room, add 150mL of water for injection and stir to dissolve, then add to the batching tank; weigh 1080mg of liraglutide , 3000mg of sitagliptin phosphate (calculated as sitagliptin), dissolved in 50mL of water for injection, added to the solution in the above liquid mixing tank, stirred and dissolved until the solution was clear, added 0.1N sodium hydroxide, adjusted the pH of the solution to 8.4 , add the remaining amount of injection water to make up the volume, and use a 0.22μm filter membrane to filter and sterilize; dispense it into injection pens, each 3ml, 100 in total.

Embodiment 3

[0055] Example 3: Preparation of liraglutide and sitagliptin injection

[0056] 1. Injection formula

[0057]

[0058] 2. Preparation process

[0059] Weigh 3000mg of chlorobutanol and 2500mg of propylene glycol in a 10,000-class clean room and a 100-class ultra-clean workbench in a clean room, add 150mL of water for injection and stir to dissolve, then add to the batching tank; weigh 600mg of liraglutide , 600mg of sitagliptin phosphate (calculated as sitagliptin), dissolved in 50mL of water for injection, added to the solution in the above liquid mixing tank, stirred and dissolved until the solution was clear, added 0.1N sodium hydroxide, adjusted the pH of the solution to 8.4 , add the remaining amount of injection water to make up the volume, and use a 0.22μm filter membrane to filter and sterilize; dispense it into injection pens, each 3ml, 100 in total.

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PUM

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Abstract

The invention belongs to the technical field of medicine preparation, and discloses a pharmaceutical composition containing a therapeutically effective amount of a glucagon-like peptide-1 (GLP-1) analogue and a dipeptidyl peptidase-4 (DPP-4) inhibitor and a preparation method thereof. The composition can effectively prevent, retard and treat type II diabetes, especially can effectively control the blood glucose concentration, and also can be used for treating diseases related to rising of the blood glucose concentration. In addition, the composition can reduce the use dosage of the GLP-1 analogue and the DPP-4 inhibitor, so as to effectively reduce side effects of the GLP-1 analogue and the DPP-4 inhibitor and improve the patient tolerance level.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a pharmaceutical composition containing a GLP-1 analogue and a DPP-4 inhibitor and a preparation method thereof. Background technique [0002] Glucagon-like peptide-1 (GLP-1) is a hormone secreted by intestinal cells that can promote insulin secretion. After a person eats food, the intestinal tract is stimulated to secrete this hormone, thereby lowering blood sugar. In order to make GLP-1 into a drug for clinical use, scientists precisely modified the peptide chain of human GLP-1, so that its half-life was extended from 2 minutes to 13 hours, and the resulting long-acting human GLP-1 1 analog, named "liraglutide". [0003] Liraglutide, a drug for treating type II diabetes developed by Novo Nordisk in Denmark, is a GLP-1 receptor agonist. As a subcutaneous injection, it needs to be injected once a day and can play a role Good blood sugar and body weight lowering ef...

Claims

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Application Information

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IPC IPC(8): A61K45/00A61K38/26A61K9/08A61P3/10A61K31/40A61K31/513
Inventor 马亚平袁建成
Owner HYBIO PHARMA
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