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Recombined human blood vessel endothelial inhibin sustained-release injection composition

A technology of vascular endothelium and inhibin, which is applied in the field of medicine, can solve the problems of loss of protein activity, complex and difficult industrialization of microsphere preparations, etc., and achieve the effects of maintaining protein activity, mild preparation conditions, and low cost

Active Publication Date: 2012-09-05
SHANDONG SIMCERE BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the industrialization of microsphere preparations is complex and difficult
For protein drugs, complex processes and severe conditions may lead to loss of protein activity
There is no sustained-release microsphere preparation of protein drugs in the market

Method used

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  • Recombined human blood vessel endothelial inhibin sustained-release injection composition
  • Recombined human blood vessel endothelial inhibin sustained-release injection composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Dissolve 650mg of PLGA (Mw=15000, polylactic acid:glycolic acid=50:50, provided by Shandong Institute of Medical Devices) in 1.16ml of N-methyl-2-pyrrolidone, shake and dissolve in a water bath at 37°C for 24 hours. Accurately weigh 0.6g of the polymer solution in a 5ml PE tube, add Endostar 0.032g freeze-dried powder (wherein the excipient is sucrose, and the mass ratio of the excipient to recombinant human endostatin is 0.5:1), use once Mix by syringe aspiration approximately 100 times. A composition was obtained, wherein the polymer accounted for 33.9% by weight of the composition, the solvent accounted for 62.7% of the composition, and Endostar was 10% by weight of the polymer. Take an appropriate amount of the mixed composition, add it to the bottom of a 5ml PE tube, then add 1ml of phosphate buffer (0.05mol / L, pH7.4), PLGA is solidified to form a sustained release system, and the sealed PE tube is placed at a constant temperature of 37°C in a water bath shaker. ...

Embodiment 2

[0031] Add 0.419ml N-methyl-2-pyrrolidone and 0.376ml glyceryl triacetate to 650mg PLGA (Mw=13000, polylactic acid:glycolic acid=65:35, provided by Durect, USA), and dissolve in a water bath at 37°C for 48 hours . Accurately weigh 0.7g of the polymer solution in a 5ml PE tube, add Endostar 0.060g freeze-dried powder (wherein the excipient is mannitol, and the mass ratio of the excipient to recombinant human endostatin is 3: 1), use Mix approximately 100 times with a single-use syringe. A composition was obtained, wherein the polymer accounted for 42.0 wt% of the composition, the solvent accounted for 55.9% of the composition, and Endostar was 5 wt% of the polymer. Take an appropriate amount of the mixed composition, add it to the bottom of a 5ml PE tube, then add 1ml of phosphate buffer (0.05mol / L, pH7.4), PLGA is solidified to form a sustained release system, and the sealed PE tube is placed at a constant temperature of 37°C in a water bath shaker. Take 0.1ml of the releas...

Embodiment 3

[0033] Add 1.195ml of methyl benzoate to 650mg of PLGA (Mw=15000, polylactic acid:glycolic acid=50:50), and dissolve in a water bath at 37°C for 48 hours. Accurately weigh 0.6g of the polymer solution into a 5ml PE tube, add 0.195g of Endostar spray-dried powder, and use a disposable syringe to pump and mix about 100 times. A composition was obtained, wherein the polymer accounted for 30.3% by weight of the composition, the solvent accounted for 60.6% of the composition, and Endostar was 30% by weight of the polymer. Take an appropriate amount of the mixed composition, add it to the bottom of a 5ml PE tube, then add 1ml of phosphate buffer (0.05mol / L, pH7.4), PLGA is solidified to form a sustained release system, and the sealed PE tube is placed at a constant temperature of 37°C in a water bath shaker. Take 0.1ml of the release solution in the PE tube of each sampling point, and add the same volume of fresh phosphate buffer at the same time. The content of Endostar in the sa...

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Abstract

The invention relates to the pharmaceutical technology field and discloses a sustained-release injection composition of rhEndostatin and the application thereof. The composition comprises one or more than one biodegradable thermoplastic polymers, one or more than one biocompatible non-proton polar solvents and the rhEndostatin. The injectable composition can change the release behavior of the rhEndostatin and be applicable to preparing injectable drugs which release the rhEndostatin sustainedly.

Description

technical field [0001] The invention relates to the technical field of medicine, and is a slow-release injection composition of recombinant human endostatin (rhEndostatin). Background technique [0002] In the 1960s, Dr. Folkman of Harvard Medical School put forward the hypothesis that "tumor growth depends on blood vessel growth", that is, angiogenesis plays an important role in the growth and metastasis of solid tumors, and in 1971 he proposed "starving tumors to death". therapy" theory. In order to stimulate angiogenesis, tumor cells will upregulate a series of angiogenesis factors, such as acidic and basic fibroblast growth factors (aFGF, bFGF) and vascular endothelial growth factor (VEGF). At the same time, some angiogenesis inhibitors will also be produced. The opening and closing of the angiogenic phenotype in the tissue will depend on the dynamic balance between angiogenesis stimulators and inhibitors in the local area of ​​the tissue (Folkman, J. Nat. MED. 1: 27-3...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/17A61K47/34A61P35/00
Inventor 王青松沈洁刘春晖李海瑞林巧平许向阳
Owner SHANDONG SIMCERE BIO PHARMA CO LTD
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