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Recombinant human endostatin nanoparticle composition for injection and preparation method thereof

A technology of vascular endothelial and composition, applied in the field of recombinant human vascular endostatin nanoparticle composition for injection and its preparation, can solve the problems of complex production process, loss of drug activity, high quality requirements, etc., and achieve low cost, high protein The effect of little effect on activity and simple and feasible process route

Inactive Publication Date: 2011-01-26
JIANGSU SIMCERE PHARMACEUTICAL R & D CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Although microsphere technology has many advantages, the production process of microspheres is very complicated and generally requires specialized and sterile production equipment; organic solvents are used in the production process, and it is usually difficult to produce products with low solvent residues and is easily damaged drugs may degrade (or lose activity) during processing; materials used in microspheres are of high quality and expensive; developing these complex products is challenging, especially due to financial and / or time There are many difficulties in the development process of

Method used

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  • Recombinant human endostatin nanoparticle composition for injection and preparation method thereof
  • Recombinant human endostatin nanoparticle composition for injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0026] Weigh 100 mg of carboxy chitosan with a molecular weight of 100,000 Daltons and dissolve it in 50 ml of Span-80 solution. Prepare 4ml of 5mg / ml sodium sulfate solution with distilled water. Add 30 mg of Endostar acetate buffer solution (pH5.5) into the chitosan solution, slowly add sodium sulfate solution dropwise under magnetic stirring, react for 30 minutes, ultrasonicate for 5 minutes at 100 W power, and centrifuge at 10,000 rpm for 30 minutes. Minutes to separate the nanoparticles. The obtained nanoparticles were redispersed in 50 ml of water, 1 g of fructose was added, and freeze-dried to obtain recombinant human endostatin nanoparticles. The drug loading of the obtained nanoparticles was 17.1%.

Embodiment 2

[0028]Weigh 500 mg of carboxymethyl chitosan with a molecular weight of 200,000 Daltons and dissolve it in 50 ml of 1% acetic acid solution. Prepare 20ml of 5mg / ml sodium alginate solution with distilled water. Add 200 mg Endostar acetate buffer solution (pH5.5) into the chitosan solution, slowly add sodium alginate solution dropwise under magnetic stirring, react for 60 minutes, and centrifuge the above solution at 4 degrees Celsius and 10,000 rpm For 30 minutes, the nanoparticles were isolated. The obtained nanoparticles were redispersed in 50 ml of water, 1 g of sucrose was added, and freeze-dried to obtain recombinant human endostatin nanoparticles. The drug-loaded weight of the obtained nanoparticles is 20.7%.

Embodiment 3

[0030] Weighing 250 mg of chitosan with a molecular weight of 150,000 Daltons was dissolved in 50 ml of 1% acetic acid solution to obtain a 5 mg / ml chitosan solution. Prepare 20ml of 2.5mg / ml sodium tripolyphosphate solution with distilled water. Add 100mg of Endostar phosphate buffer (pH5.5) and 10ml of polyethylene glycol into the chitosan solution, slowly add sodium tripolyphosphate solution dropwise under magnetic stirring, react for 10 minutes, and ultrasonicate the probe for 2 minutes at 100W power, and put The above solution was centrifuged at 4°C and 10,000 rpm for 30 minutes to separate nanoparticles. The obtained nanoparticles were redispersed in 50 ml of water, 1.5 g of trehalose was added, and freeze-dried to obtain recombinant human endostatin nanoparticles. The drug loading of the obtained nanoparticles was 22.1%.

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Abstract

The invention relates to a recombinant human endostatin nanoparticle composition for injection and a preparation method thereof. The recombinant human endostatin nanoparticle composition can be prepared by methods such as a covalent bond linking method and an ionic induction method and by using biologically degradable polymer as a carrier. The recombinant human endostatin nanoparticle composition can be prepared into injection and freeze-dried powder injection, has high medicament carrying capacity and uniform particle size distribution, is suitable for intravenous injection and can delay the release of recombinant human endostatin.

Description

technical field [0001] The invention relates to a recombinant human endostatin nanoparticle composition for injection and a preparation method thereof. The recombinant human endostatin nanoparticle composition of the present invention has high drug loading capacity and uniform particle size distribution, can be made into injection and freeze-dried powder for intravenous injection, and simultaneously delays the release of recombinant human endostatin. Background technique [0002] Professor Folkman of Harvard Medical School in the United States put forward the theory that "tumor growth depends on angiogenesis" in the 1960s, that is, during the growth and metastasis of solid tumors, angiogenesis plays a vital role. At this time, tumor cells will emit some Cytokines (aFGF, bFGF, VEGF, etc.) that promote the proliferation of blood vessels to tumor tissue. In the 1970s, Professor Folkman proposed the theory of "starving tumor therapy" by using endostatin (Endostatin) to inhibit ...

Claims

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Application Information

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IPC IPC(8): A61K38/17A61K9/10A61K9/19A61K47/36A61K47/34A61P35/00A61K47/10
Inventor 李玲王青松刘春辉许向阳
Owner JIANGSU SIMCERE PHARMACEUTICAL R & D CO LTD
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