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Nasal administration preparation containing recombinant human growth hormone and preparation method thereof

A technology of nasal administration preparation and human growth hormone, which is applied in the field of medicine to achieve the effects of increasing nasal retention time, improving bioavailability, and increasing nasal absorption

Active Publication Date: 2016-08-10
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In summary, although many attempts have been made to improve the absorption of human growth hormone through nasal administration, the effect equivalent to subcutaneous injection has not yet been achieved, and further improvement of the biological properties of human growth hormone through nasal administration is still needed. Utilization

Method used

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  • Nasal administration preparation containing recombinant human growth hormone and preparation method thereof
  • Nasal administration preparation containing recombinant human growth hormone and preparation method thereof
  • Nasal administration preparation containing recombinant human growth hormone and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Recipe: (weight percent)

[0044]

[0045]

[0046] The bioadhesive material chitosan (deacetylation degree greater than 85%) was dissolved in acetic acid-sodium acetate solution to obtain solution A.

[0047] Add recombinant human growth hormone to A solution;

[0048] Add mannitol, lauryl maltoside, and poloxamer F68, mix evenly, freeze-dry, sieve through 100 meshes to obtain 30-150 μm powder, and pack it into a nasal powder mist device to obtain the product.

[0049]Recombinant human growth hormone is a protein with 191 amino acid residues, which is completely consistent with the structure and amino acid sequence of natural human growth hormone.

Embodiment 2

[0051] Recipe: (weight percent)

[0052]

[0053] Recombinant human growth hormone is a protein composed of 192 amino acid residues with a methionine added to the N-terminal.

[0054] The preparation method is the same as in Example 1.

Embodiment 3

[0056] Recipe: (weight percent)

[0057]

[0058] Recombinant human growth hormone is a recombinant human growth hormone with a molecular weight of 20KD, 176 amino acid residues, and 15 amino acid residues at positions 32-46 of natural human growth hormone.

[0059] The preparation method is the same as in Example 1.

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Abstract

The invention discloses a nasal administration preparation containing recombinant human growth hormone and a preparation method thereof. The nasal administration preparation containing recombinant human growth hormone contains, in weight percent: 0.1-30% of a mucosal absorption promoter, Bioadhesive material 0.1-50%, recombinant human growth hormone 1-30%. The invention has the advantages of being simple and easy to implement and suitable for industrialized production. No organic solvent is used in the preparation process, and the activity of the recombinant human growth hormone is less damaged. The drug-loaded microparticles of the invention can significantly increase the residence time of the nasal cavity, increase the nasal absorption of the human growth hormone, and improve the bioavailability.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a nasal cavity drug containing recombinant human growth hormone for treating diseases such as slow growth and severe burns in children caused by endogenous growth hormone deficiency, chronic renal failure, and Turner syndrome. Formulations and methods for their preparation. Background technique [0002] Since the advent of recombinant human growth hormone (rhGH) in 1985, it has completely solved the problem of Creutzfeldt-Jakob disease caused by the scarcity of cadaver-derived human GH sources and potential epigastric virus infection, and provided a therapeutic approach for patients with growth hormone deficiency (GHD) . It has the same effect as human endogenous growth hormone, can increase the weight of pituitary removed rats, and promote the growth of tibia and cartilage. At the same time, it can also promote protein synthesis in the whole body, correct negative ammonia balance after...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/27A61K47/26A61K47/36A61K9/12A61P17/02A61P5/06
Inventor 吴闻哲侯惠民姚孝林
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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