Nasal cavity drop for treating diabetes and preparation method thereof

A technology of diabetes and nasal cavity, which is applied in the field of nasal cavity drops for the treatment of diabetes and its preparation, which can solve the problems of surrounding environmental pollution, patient pain, nerve paralysis, etc., and achieve the effect of avoiding potential safety hazards, avoiding pain and inconvenience

Inactive Publication Date: 2009-12-16
南京凯瑞尔纳米生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, GLP-1 will be rapidly degraded and inactivated by dipeptidyl peptidase IV (dipeptidy I peptidase IV, DPP IV) in vivo, and its half-life is less than 2 minutes
2. Purulent infection at the injection site caused by incomplete disinfection of instruments, pollution of the surrounding environment,

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Accurately weigh 1.0g of calcium chloride and dissolve it in 500ml deionized water to make a calcium chloride solution; accurately weigh 1.0g of dibasic sodium phosphate and dissolve it in 500ml of deionized water to make a dibasic hydrogen phosphate solution; accurately weigh citric acid Sodium 0.4g was dissolved in 80ml deionized water to make sodium citrate solution, calcium chloride solution, dibasic sodium phosphate solution and sodium citrate solution were mixed according to the volume ratio of 2:2:1, stirred at room temperature for 48 hours, and ultrasonically After the treatment, centrifuge and discard the supernatant to form a solution containing calcium phosphate nanoparticles. The concentration of calcium phosphate nanoparticles in the solution is 0.5 mg / ml. The calcium phosphate nanoparticle solution and the 20 mg / mL exenatide aqueous solution were mixed and stirred for 2 hours at a weight ratio of 1:1, centrifuged, and the supernatant was discarded to obtain...

Embodiment 2

[0024] Accurately weigh 1.0g of calcium chloride and dissolve it in 500ml deionized water to make a calcium chloride solution; accurately weigh 1.0g of dibasic sodium hydrogen phosphate and dissolve it in 500ml of deionized water to make a dibasic hydrogen phosphate solution; Dissolve 0.4 g of sodium citrate in 80 ml of deionized water to make a sodium citrate solution, accurately weigh 50 mg of exenatide and dissolve it in 5 mL of deionized water to make an aqueous solution of exenatide, mix and stir the above solution for 48 hours, and ultrasonically After treatment, centrifuge, discard the supernatant, and obtain the complex of calcium phosphate nanoparticles and exenatide; the complex is diluted with water to form a drug solvent, and the exenatide in the diluted drug solvent Content is 0.01~0.5mg / ml; Add the following adjuvant commonly used in aqueous medicine in medicine solvent: pyrosulfite, sodium chloride, wherein: the adding amount of pyrosulfite is 0.05% of medicine s...

Embodiment 3

[0026] Nasal Drug Metabolism Test

[0027] Experimental animals:

[0028] SD rats, 180-200g, male, 8

[0029] Experimental drug:

[0030] Test group: the nasal cavity drops obtained in Example 2, the exenatide concentration in the nasal cavity drops was 16 mg / ml.

[0031] Control group: exenatide was diluted with water for injection, and the concentration of the effective drug exenatide after dilution was 16 mg / ml.

[0032] experimental method:

[0033] The experimental rats were reared for 3 days in advance, and fasted for 12 hours the day before the test.

[0034] Divide the rats into four parallel groups A, B, C, and D, with 2 rats in each group, wherein, groups A, B, and C are the test groups, and group D is the control group, and each group is given nasal drops of 5 μl / rat. The dosage is 100μg / 200g. In each group, 0.3 ml of orbital blood was collected from one mouse at 5, 10, 20, and 30 minutes after administration, and the blood was centrifuged at 4°C and 3,000 rpm f...

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Abstract

The invention discloses a nasal cavity drop for treating diabetes and a preparation method. The nasal cavity drop comprises solvent and accessories, and is characterized in that the solvent contains a compound of calcium phosphate nano particles and exenatide, the weight ratio of the calcium phosphate nano particles to the exenatide in the compound is 1-10:0.1-10, and the content of the exenatide in the solvent is 0.01 to 0.5 milligram per milliliter. The preparation method for the nasal cavity drop comprises the following steps: mixing aqueous solutions of calcium salt, phosphate, citrate and exenatide to form the compound of the calcium phosphate nano particles and the exenatide, adding the accessories which are frequently used for aqueous agent into the mixture, detecting and adjusting the pH of the solution, and finally forming the nasal cavity drop, wherein the weight ratio of the calcium phosphate nano particles to the exenatide in the compound is 1-10:0.1-10, and the content of the diluted exenatide in the solvent is 0.01 to 0.5 milligram per milliliter.

Description

technical field [0001] The invention relates to a nasal cavity drop and a preparation method thereof, in particular to a nasal cavity drop containing exenatide for treating diabetes and a preparation method thereof. Background technique [0002] Diabetes is a common metabolic endocrine disease. Because of its high morbidity, mortality and disability rate, it seriously endangers human health, and it is increasingly concerned by the medical community. From the perspective of clinical incidence, most of them are type II diabetes, and its clinical symptoms are that the glucose content in blood and urine exceeds the normal range. Blood sugar levels are mainly regulated by insulin and glucagon. Glucagon accelerates the breakdown of glycogen through a series of reactions. Increase the concentration of glucose in the body, on the contrary, insulin accelerates the synthesis of glycogen and reduces the concentration of blood sugar. In the body, glucagon is first synthesized as a pr...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K38/17A61K47/02A61P3/10
Inventor 河清冯振卿管晓虹袁伟民冯鲁中张学智
Owner 南京凯瑞尔纳米生物技术有限公司
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