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Insulin oral spray and preparation process method thereof

A technology for oral sprays and insulin, which is applied in aerosol delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of large particle size and long time of soybean lecithin, and achieve easy absorption and good preparation The effect of high particle size and light transmittance

Pending Publication Date: 2020-02-18
王晶
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Through further research, it is found that there are deficiencies in this preparation process: get soybean lecithin, add the ethanol solution of propylene glycol and borneol, slowly stir until the soybean lecithin is completely dissolved, add the ethanol solution of propylene glycol and borneol in the slowly stirred soybean lecithin, Not only does it take a long time, but the particle size of the obtained soybean lecithin is relatively large. We researched and passed quality inspection indicators and found that the size of the emulsion particle size indirectly reflects the quality. The smaller the particle size, the higher the light transmittance, and the emulsion particle size The smaller the diameter, the more fully the inclusion, the better the absorption, the better the bioavailability of the drug, and the better the curative effect

Method used

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  • Insulin oral spray and preparation process method thereof
  • Insulin oral spray and preparation process method thereof
  • Insulin oral spray and preparation process method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] The process prescription is as follows:

[0036]

[0037] 25g of soybean lecithin and 50g of propylene glycol were sheared for 135 minutes, and the rotational speed of the shearing operation was maintained at 2000rpm to 3000rpm. After the shearing treatment, the light transmittance was above 40%; then the ethanol solution of borneol was added and stirred;

[0038]Then the above solution is added to the phosphate buffer solution, fully sheared, and the time is 610min. The rotating speed of the shearing operation is maintained at 2000rpm~3000rpm, and the light transmittance is 54.8% dilute solution, which is much better than that of the prior art polypeptide The light transmittance obtained by the drug oral spray is about 40% with a dilute solution.

Embodiment 2

[0040] The process prescription is as follows:

[0041]

[0042] 25g of soybean lecithin and 75g of propylene glycol were sheared for 113 minutes. The rotational speed of the shearing operation was maintained at 2000rpm-3000rpm. After the shearing treatment, the light transmittance was above 40%. Add the ethanol solution of borneol and stir;

[0043] Then the above solution is added to the phosphate buffer solution, fully sheared, and the time is 560min, and the rotating speed of the shearing operation is maintained at 2000rpm~3000rpm, and the light transmittance is 60.8% dilute solution, which is also much better than that of the prior art polypeptide The light transmittance obtained by the drug-like oral spray is about 40% with a dilute solution.

Embodiment 3

[0045] The process prescription is as follows:

[0046]

[0047] 25g of soybean lecithin and 120g of propylene glycol were sheared for 128 minutes. The rotational speed of the shearing operation was maintained at 2000rpm to 3000rpm. After the shearing treatment, the light transmittance was above 40%. Add the ethanol solution of borneol and stir until the soybean lecithin was completely dissolved. ;

[0048] Then add the above solution into the phosphate buffer solution, fully shear, it takes 650min, and the rotating speed of the shearing operation is maintained at 2000rpm~3000rpm, and the light transmittance is 52.2% dilute solution, which is also much better than that of polypeptides in the prior art The light transmittance obtained by the drug-like oral spray is about 40% with a dilute solution.

[0049] The above-mentioned examples only take recombinant human insulin as an example. The formulation of the insulin oral spray composition and its production process in the p...

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Abstract

The present invention discloses a preparation process method of an insulin oral spray. The insulin oral spray comprises insulin, an accelerant, cosolvents, a flavoring agent, a microorganism-inhibiting agent and a buffer solution, and is characterized in that every 1,000 ml of the oral spray specifically comprises 10,000 U-80,000 U of insulin, 15-45 g of soybean lecithin as the accelerator, 50-120g of propylene glycol and 5-15 ml of ethanol as the cosolvents, 1-5 g of borneol as the flavoring agent, 1-4 g of phenol as the microorganism-inhibiting agent, and a phosphate buffer solution with apH of 6.8-7.8 as the buffer solution. By improving a component formula and the preparation process of the insulin oral spray, preparation quality of the medicine is improved, production period is shortened, and a safer, simpler and more convenient administration mode and medicine can be provided for patients with diabetes mellitus.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and more specifically relates to a manufacturing process of insulin oral spray, especially corresponding to the formulation and preparation method of insulin such as insulin oral spray. Background technique [0002] Insulin generally includes recombinant human insulin, animal insulin, and insulin analogues known in the prior art; taking recombinant human insulin as an example, recombinant human insulin is easily degraded by gastric acid and various digestive enzymes in the gastrointestinal tract, and cannot be directly Oral administration has been limited to injection administration only. For example, insulin is the best drug for diabetic patients, but it can only be administered by injection. If a person injects 3 times a day for a total of 30 years, it means that he needs to inject more than 30,000 times. Pain is difficult for normal people or diabetic patients not treated with insul...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/28A61K9/12A61K9/107A61K47/10A61K47/24A61P3/10
CPCA61K38/28A61K9/006A61K47/10A61K47/24A61K9/1075A61P3/10
Inventor 王晶徐辉碧杨继林陈新
Owner 王晶
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