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Exenatide Nasal Drops for Type Ⅱ Diabetes

A technology of peptide nasal drops and exenatide, 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 increase the cost of drugs, so as to achieve convenient use and reduce pain. Effect

Active Publication Date: 2021-06-04
SHAANXI HUIKANG BIO TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] 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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  • Exenatide Nasal Drops for Type Ⅱ Diabetes
  • Exenatide Nasal Drops for Type Ⅱ Diabetes
  • Exenatide Nasal Drops for Type Ⅱ Diabetes

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Taking the preparation of exenatide 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:

[0027] Exenatide 5.8g

[0028] Solutol HS15 200g

[0029] Add distilled water to 1000mL

[0030] Its preparation method is as follows:

[0031] Put Solutol HS15 into a container and add 400mL of distilled water, heat to 45°C to dissolve, so that the concentration of SolutolHS15 is 0.3g / mL, store in a refrigerator at 4°C, take it out, add exenatide, add distilled water to 1000mL, and stir to make it Fully dissolve, bottle, 1.5mL per bottle, sterilize with circulating steam at 100°C for 30 minutes, and make exenatide nasal drops, each ml contains exenatide 5.8mg, three times a day, nasal drip after meals, every Nasal drops 0.5mL each time.

Embodiment 2

[0033] Taking the preparation of exenatide 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:

[0034] Exenatide 5.8g

[0035] Solutol HS15 50g

[0036] Add distilled water to 1000mL

[0037] Its preparation method is the same as that of Example 1, and exenatide nasal drops are prepared, containing 5.8 mg of exenatide per milliliter, and the usage and dosage are the same as those of Example 1.

Embodiment 3

[0039] Taking the preparation of exenatide 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:

[0040] Exenatide 5.8g

[0041] Solutol HS15 250g

[0042] Add distilled water to 1000mL

[0043] Its preparation method is the same as that of Example 1, and exenatide nasal drops are prepared, containing 5.8 mg of exenatide per milliliter, and the usage and dosage are the same as those of Example 1.

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Abstract

An exenatide nasal drop for treating type II diabetes is prepared from exenatide and Solutol HS15 according to a conventional preparation method. The present invention has been compared with exenatide in drug efficacy experiments, which proves that the blood sugar reduction rate of mice is 60.1%, and the hypoglycemic effect of nasal administration is significantly better than that of exenatide, and can be used for a long time, safe, effective, It is convenient to use, can reduce pain of patients, can be used for treating type II diabetes, and is suitable for long-term administration.

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] In 1995, U.S. Patent (US5424286) disclosed a kind of polypeptide Exendin-4 (H-His-Gly-Glu-H-His-Gly-Glu- Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn- Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Pro-Ser-NH2), its structure has 48% homology with human glucagon (Glucagon), and human GLP- 1 (glucagon-like peptide-1) has 53% homology. [0003] 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 insulin secretion, inhibit the release of glucagon, slow down the rate of gastric emptying, and inhibit food intake. Its role in promoting insulin secretion is based on blood sugar levels, so it can reduce the incide...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/22A61K9/08A61K47/10A61P3/10
CPCA61K9/0043A61K9/08A61K38/22A61K47/10
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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