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Liraglutide nasal drops for the treatment of type 2 diabetes

A technology of liraglutide and nasal drops, which is applied in the field of nasal drops for the treatment of type II diabetes, can solve the problems of poor patient compliance, low absorption and utilization, and increased drug costs, and achieve the effect of convenient use and reduced pain

Active Publication Date: 2020-07-21
SHAANXI HUIKANG BIO TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] For diabetic patients, long-term drug treatment is required. If injection is used, the drug administration is inconvenient and the patient's compliance is poor. The general nasal drop preparation has too low absorption and utilization, which greatly increases the drug cost.

Method used

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  • Liraglutide nasal drops for the treatment of type 2 diabetes
  • Liraglutide nasal drops for the treatment of type 2 diabetes

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Taking the preparation of liraglutide nasal drops 1000mL for the treatment of type II diabetes as an example, the following mass ratio raw materials are used to make nasal drops according to the conventional preparation method:

[0025] Liraglutide 14.4g

[0026] Solutol HS15 200g

[0027] Add distilled water to 1000mL

[0028] Its preparation method is as follows:

[0029] Put Solutol HS15 into a container and add 400mL of distilled water, heat to 45°C to dissolve, so that the concentration of Solutol HS15 is 0.3g / mL, store in a refrigerator at 4°C, take it out, add liraglutide, add distilled water to 1000mL, stir, and make It is fully dissolved, bottled, 1.5mL per bottle, sterilized by circulating steam at 100°C for 30 minutes, and made into liraglutide nasal drops, each ml contains 14.4mg of liraglutide, three times a day, nasal drip after meals, Each nasal drop 0.5mL, long-term use.

Embodiment 2

[0031] Taking the preparation of liraglutide nasal drops 1000mL for the treatment of type II diabetes as an example, the following mass ratio raw materials are used to make nasal drops according to the conventional preparation method:

[0032] Liraglutide 14.4g

[0033] Solutol HS15 50g

[0034] Add distilled water to 1000mL

[0035] The preparation method is the same as that of Example 1, and Liraglutide nasal drops are prepared, containing 14.4 mg of liraglutide per milliliter, and the dosage is the same as that of Example 1.

Embodiment 3

[0037] Taking the preparation of liraglutide nasal drops 1000mL for the treatment of type II diabetes as an example, the following mass ratio raw materials are used to make nasal drops according to the conventional preparation method:

[0038] Liraglutide 14.4g

[0039] Solutol HS15 250g

[0040] Add distilled water to 1000mL

[0041] The preparation method is the same as that of Example 1, and Liraglutide nasal drops are prepared, containing 14.4 mg of liraglutide per milliliter, and the dosage is the same as that of Example 1.

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Abstract

The invention discloses a liraglutide nose drops for treating type II diabetes, which is prepared from liraglutide, Solutol HS15 according to a conventional preparation method. The contrast pharmacological experiment with liraglutide provides that the blood sugar decrease rate of a mice is 76.7%; the sugar reducing effect of nasal delivery is obviously better than liraglutide, and the nose drops can be used for a long time, and is safe, effective, and convenient to use, and able to reduce the patient's pain; moreover, the liraglutide nose drops can be applied to treat type II diabetes and suitable for long-term supply.

Description

technical field [0001] The invention belongs to the technical field of medical preparations for parenteral administration, and in particular relates to nasal drops for treating type II diabetes. Background technique [0002] Liraglutide is a synthetic acylated glucagon-like peptide-1 analogue, which has more than 97% sequence similarity and only 3% non-homology with human natural GLP-1. The structural changes mainly include the following two points. One is that the 34th lysine of the natural GLP-1 molecule is replaced by arginine, and the other is that a fatty acid side chain is added to the 26th lysine. On the one hand, this molecular change not only retains and prolongs the binding time between the acylated product and the protein, but on the other hand, it obviously overcomes the shortcoming of GLP that is easily degraded. Studies have shown that, as an analog of GLP-1, Exendin-4 can interact with GLP-1 receptors, stimulate the regeneration of pancreatic β cells, promote...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/14A61K38/26A61P3/10
CPCA61K9/0043A61K9/08A61K38/26A61K47/14
Inventor 苏晨灿郭添韩广张忠旗王慧李乾王惠嘉高长波赵金礼杨晓琳
Owner SHAANXI HUIKANG BIO TECH CO LTD
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