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Recombinant human endostatin temperature-sensitive gel composition for injection

A technology of vascular endothelial and composition, which is applied in the field of temperature-sensitive gel composition of recombinant human endostatin for injection, which can solve the problems of poor clinical compliance, achieve little effect on protein activity, simple and feasible process route, and low cost Effect

Active Publication Date: 2011-01-05
SHANDONG SIMCERE BIO PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Poor clinical compliance due to frequent injections

Method used

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  • Recombinant human endostatin temperature-sensitive gel composition for injection
  • Recombinant human endostatin temperature-sensitive gel composition for injection

Examples

Experimental program
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Embodiment 1

[0023] Prepare isotonic citrate buffer solution with pH 6.0, keep it refrigerated for 30min, then slowly add 10% (w / v) Poloxamer 188 and 15% (w / v) Poloxamer 407, and continue stirring to disperse Uniformly until the polymer is completely dissolved to obtain a clear solution. Take 2 mL of the above solution and place it in an ice-water bath for magnetic stirring, add 500 mg of Endostar buffer solution, stir to mix evenly, and obtain the composition. In the composition, poloxamer accounts for 16.7% of the composition, Endostar accounts for 16.7% of the composition, and the rest are biocompatibility auxiliary agents. The mixed composition was placed in a 37° C. water bath to solidify to form a sustained-release release system. The formed gel was placed in a constant temperature water bath shaker at 37°C, and 10 mL of phosphate buffer saline PBS 7.4 was added. Take 1mL of the release solution at each sampling point, and add the same volume of fresh phosphate buffer at the same t...

Embodiment 2

[0024] Dissolve methylcellulose in hot water above 90°C, stir to make the polymer completely wet and disperse evenly, add an appropriate amount of cold water to make the concentration 30mg / mL, stir well to dissolve, and place in a refrigerator at 4°C overnight , to obtain a clear solution. Take 1mL of the above solution and place it in an ice-water bath for magnetic stirring, add 30mg of Endostar buffer solution, 0.1mL polyethylene glycol aqueous solution (40mg / mL), 0.1mL sodium citrate aqueous solution (20mg / mL), stir to mix evenly, get the composition. In the composition, methyl cellulose accounts for 2.8% of the composition, Endostar accounts for 2.8% of the composition, and the rest are biocompatibility auxiliary agents. The mixed composition was placed in a 37° C. water bath to solidify to form a sustained-release release system. The formed gel was placed in a constant temperature water bath shaker at 37°C, and 10 mL of phosphate buffer saline PBS 7.4 was added. Take 1...

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Abstract

The invention relates to a recombinant human endostatin temperature-sensitive gel composition for injection can release medicaments slowly and stably through one time of medicament administration, so the medicament administration times are reduced, physiological pain in patients is relieved and the clinical compliance of the patients is improved.

Description

technical field [0001] The invention relates to a temperature-sensitive gel composition of recombinant human endostatin for injection. The recombinant human endostatin temperature-sensitive gel composition for injection of the present invention can slowly and steadily release the drug after one administration, thereby reducing the number of administrations, reducing the physiological pain of the patient, and improving the clinical compliance of the patient. Background technique [0002] Temperature-sensitive gels are the most widely studied class of in situ gels. It dissolves drugs and polymers in a suitable solvent and injects them locally subcutaneously. At the site of administration, the polymer solidifies under physiological conditions to form a semi-solid or solid drug reservoir. It is a semi-solid or liquid preparation formed by polymer materials administered in a solution or semi-solid state, responding to external stimuli (temperature) at the site of administration,...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K38/17A61K47/32A61K47/34A61K47/38A61K47/36A61P35/00A61K47/10
Inventor 李玲王青松刘春晖许向阳
Owner SHANDONG SIMCERE BIO PHARMA CO LTD
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