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Rectal suppository of protein medicines and its preparing method and use in systemic disease therapy

A protein, therapeutic effect technology, applied in the fields of peptide/protein composition, suppository delivery, drug combination, etc., can solve the problems of loss of activity and poor permeability of biological membranes

Inactive Publication Date: 2007-01-24
CHANGCHUN GENESCIENCE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] When protein and polypeptide drugs are administered rectally, the main problems they face are poor biofilm permeability and loss of activity

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Melt 500mg of semi-synthetic fatty acid glycerides at 70±5°C, add 50mg of trehalose, 150mg of cyclodextrin, and 0.01mg of ascorbic acid to the melted matrix, mix well, lower the temperature to 40±2°C, add the reconstituted Human growth hormone 17.0mg, mold filling, cooling, molding, demoulding, packaging.

Embodiment 2

[0074] Melt 750mg of semi-synthetic fatty acid glycerides at 70±5°C, add 50mg of trehalose, 150mg of cyclodextrin, and 0.01mg of ethyl paraben to the molten matrix, and after mixing evenly, the temperature drops to 40±2 ℃, add 17.0 mg of recombinant human growth hormone, fill the mold, cool, form, demould, and pack.

Embodiment 3

[0076] Melt 1000mg of semi-synthetic fatty acid glycerides at 70±5°C, add 50mg of histidine, 150mg of cyclodextrin, and 0.01mg of methyl paraben to the melted matrix, and after mixing evenly, the temperature drops to 40±5°C. At 2°C, add 17.0 mg of recombinant human growth hormone, fill the mold, cool, form, demould, and pack.

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PUM

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Abstract

The present invention relates to a kind of protein medicine suppository administrated locally through anus and rectum to reach systemic treatment and its preparation process. The preparation process of the suppository includes mixing matrix component and other supplementary material in certain ratio, high pressure sterilizing at 121deg.c for 30 min and adding protein medicine at the temperature of 40+ / -5deg.c, cooling, molding, de-molding and packing. The present invention features that by means of the improved suppository preparation, it is possible to administrate protein medicine through anus and rectum for treating systemic disease.

Description

technical field [0001] The invention relates to a protein drug suppository and a preparation method thereof, specifically, the protein drug is made into an anorectal administration suppository through appropriate preparation formula and preparation process, and the drug is fully absorbed through the rectum to achieve systemic administration. The purpose of therapeutic effect. Background technique [0002] With the rapid development of bioengineering technology and the continuous emergence of biotechnology active drugs, many biological products have been widely used in the prevention, treatment and prognosis of clinical diseases. According to reports, so far, more than 40 kinds of biological products drugs have been approved for marketing at home and abroad, and biological products drugs in the research and development stage have also become hot spots in the pharmaceutical field. [0003] Among the biologically active drugs, the vast majority are protein drugs. Since the ph...

Claims

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Application Information

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IPC IPC(8): A61K38/22A61K38/21A61K9/02A61P1/16A61P31/14A61P35/00
CPCA61K9/0031A61K38/00A61P1/16A61P5/06A61P31/12A61P31/14A61P35/00A61P35/02
Inventor 金磊裴瑾段明华郑宇惠
Owner CHANGCHUN GENESCIENCE PHARM CO LTD
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