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Self-assembling protein for forming pharmaceutical compound

A drug compound and self-assembly technology, which is applied in drug combination, drug delivery, peptide/protein components, etc., can solve the problems of imperfect drug delivery system, low bioavailability, short half-life, etc., to ensure oral stability, Effect of Prolonged Concentration Duration

Inactive Publication Date: 2017-06-13
天津世传生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, nucleic acid molecules, proteins, and peptides also have outstanding problems, such as imperfect drug delivery systems, poor stability, short half-life in vivo, and low bioavailability, etc.

Method used

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  • Self-assembling protein for forming pharmaceutical compound
  • Self-assembling protein for forming pharmaceutical compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The complex of embodiment 1GLP-1 polypeptide and self-assembly protein

[0022] Weigh 90mg of self-assembled protein lyophilized powder and dissolve it in 1ml of pH 3.0 phosphate buffer, then weigh 0.3mg of GLP-1 lyophilized powder, add it to the self-assembled protein solution, mix thoroughly, and Stir at 4°C for 3 hours, freeze-dry to obtain solid powder of the complex.

Embodiment 2

[0023] Compound of embodiment 2GLP-1 polypeptide and self-assembly protein

[0024] Weigh 90mg of self-assembled protein lyophilized powder and dissolve it in 1ml of pH 7.0 phosphate buffer, then weigh 6mg of GLP-1 lyophilized powder, add it to the above self-assembled protein solution, mix thoroughly, and °C, stirred for 3 hours, and freeze-dried to obtain a solid powder of the complex.

Embodiment 3

[0025] The preparation of embodiment 3 pharmaceutical compositions

[0026] Put 0.05g of poloxamer, 0.2g of mannitol, 0.1g of lactose, and 3ml of water for injection into a 10ml container, stir to dissolve, add 1mol / L citric acid or sodium hydroxide to adjust the pH to 3.0, and cool to 5°C, add 5ml of the complex solution prepared by the method in Example 3 into it, continue to adjust the pH to 3.0, and add water to 10ml. Add 10mg of activated carbon, stir at 5°C for 20 minutes, remove the activated carbon by filtration, filter and sterilize with a microporous membrane (Millipore, Inc), and divide the filtrate into 0.2ml per tube, pre-freeze for 2 hours, then freeze Press and dry for 12 hours until the sample temperature reaches 5°C, and then dry for 2 hours to obtain a white loose block, which is then sealed to obtain the pharmaceutical composition of the complex, which is placed in a prefilled syringe with a specification of 100ug / bottle , Store below 4°C.

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PUM

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Abstract

The invention relates to a self-assembling protein for forming a pharmaceutical compound, belonging to the technical field of biology. The self-assembling protein has an amino acid residue sequence shown in SEQ ID NO 1 as well as a general formula as follows: QQCTTGQLQCCESTSTANDPATSELLGLIGVVISDVDA LVGLTCSPISVIGVGSGSACTANPVCCDSSPIGGLVSIGCVPVNV SEQ ID NO 1. A supporting agent based on the self-assembling protein and a pharmaceutical composition prepared from the supporting agent can be used as oral feeding medication carriers of GLP-1 for treating type 2 diabetes mellitus.

Description

technical field [0001] The present invention relates to the field of pharmaceutical excipients, in particular, the present invention relates to a self-assembling protein and its preparation method and application, the self-assembling protein has the ability to form a complex with glucagon-like peptide-1 (GLP-1) , can increase the stability of the drug against biodegradable factors, so that GLP-1 can be orally absorbed. Background technique [0002] Research on biotechnology drugs (especially nucleic acid molecules, proteins, and peptides) as drugs has achieved rapid development. In a survey report in 2009, 324 biotechnology drugs (including clinical trials or drugs under regulatory review) Almost 150 diseases are covered, including cancer, autoimmune diseases, and infectious diseases such as AIDS. However, nucleic acid molecules, proteins, and peptides also have outstanding problems, such as imperfect drug delivery systems, poor stability, short half-life in vivo, and low b...

Claims

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Application Information

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IPC IPC(8): C07K14/00A61K9/19A61K38/26A61K47/42A61P3/10
CPCC07K14/00A61K9/0019A61K9/19A61K38/26A61K47/42
Inventor 黄秀举龚珉
Owner 天津世传生物科技有限公司
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