Taxol nanoparticle freeze-drying preparation containing recombinant human serum albumin

A human serum albumin and nanoparticle technology, which is applied in the field of nanoparticle preparations of albumin-binding antitumor drugs and its preparation, can solve the problems of large particle size of nanoparticles, reduced industrialization value, and inability to achieve intravenous drip. , to achieve the effect of improving stability and increasing the value of industrialization

Inactive Publication Date: 2011-06-01
YUANRONG BIOLOGICAL PHARMA WUXI CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] Chinese patent (Application No.: 200810147343.5) discloses a preparation formed by encapsulating drug molecules with vesicles formed by embedding cholesterol in the phospholipid bilayer. The particle size of nanoparticles prepared from cysts is rel

Method used

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  • Taxol nanoparticle freeze-drying preparation containing recombinant human serum albumin
  • Taxol nanoparticle freeze-drying preparation containing recombinant human serum albumin
  • Taxol nanoparticle freeze-drying preparation containing recombinant human serum albumin

Examples

Experimental program
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Effect test

Embodiment 1

[0035] Add 0.3g of paclitaxel, 0.05g of vitamin E into 5-15ml of absolute ethanol (or 0.1-1ml of chloroform) to dissolve, 6.5g of soybean lecithin, 5g of recombinant human serum albumin, 10g of trehalose, add 100ml of water for injection to fully dissolve, and use phosphoric acid Sodium dihydrogen buffer salt to adjust the pH value to 5.5, fully dispersed with a high-speed disperser, emulsified by a high-pressure homogenizer to 50% with a particle size range of 100nm, sterilized and filtered, and quickly frozen to -30 degrees under sterile conditions. Freeze-dry until the water content is less than 5% to obtain the paclitaxel recombinant human albumin conjugate dry powder.

Embodiment 2

[0037] Add 1.2g of paclitaxel, 10g of soybean lecithin to 50ml of absolute ethanol (or 2-10ml of chloroform) to dissolve, add 20g of recombinant human serum albumin, 15g of soybean lecithin, 0.05g of sodium metabisulfite, 60g of trehalose, add 500ml of water for injection to fully dissolve, The buffer solution of sodium dihydrogen phosphate and disodium hydrogen phosphate is adjusted to a pH value of 5.8, fully dispersed with a high-speed disperser, homogenized and emulsified to 50% by a high-pressure homogenizer, and the particle size range is 80nm, sterilized and filtered, under sterile conditions Quickly freeze to -40°C and freeze-dry until the water content is less than 5% to obtain dry powder of paclitaxel recombinant human albumin conjugate.

Embodiment 3

[0039] Paclitaxel 0.5g, add 5-15ml absolute ethanol (or 0.5-2ml chloroform) to dissolve, soybean lecithin 15g, recombinant human serum albumin 20g, maltose 30g, add 150ml water for injection to fully dissolve, use citric acid buffer saline or hydrochloric acid Adjust the PH value to 6.0 with salt, fully disperse with a high-speed disperser, emulsify to 50% with a high-pressure homogenizer, the particle size range is 80nm, sterilize and filter, quickly freeze to -45 degrees under sterile conditions, and freeze-dry to moisture The dry powder of paclitaxel recombinant human albumin conjugate is obtained when the content is less than 5%.

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Abstract

The invention discloses a nanoparticle freeze-drying powder preparation containing recombinant human serum albumin. The preparation is prepared from the following components in mass percent: 0.05-5% of taxol, 0.1-50% of phospholipid, 1-60% of recombinant human serum albumin, 1-60% of freeze-drying supporting agent and 0.05-10% of PH regulating agent. In the invention, the average particle size of the obtained nanoparticles is less than 0.4mu m, and the obtained powder preparation is reproduced with water for injection, glucose and normal saline to form an injectable water solution the PH of which is 5.0-7.0, thereby greatly improving the industrialized value of the preparation.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a nanoparticle preparation of an albumin-binding antitumor drug and a preparation method thereof. Background technique [0002] Human albumin is a plasma protein preparation extracted from human blood by the low-alcohol method or chromatography, but the production of blood-derived products is limited by the supply of blood, and there will inevitably be periodic shortages. The source of the disease cannot be completely controlled, and the potential threat of pathogenic microorganisms cannot be completely avoided. Japan is the first to successfully develop recombinant human serum albumin and use it as a pharmaceutical excipient in the production of vaccine products. Domestically, such as North China Pharmaceutical and Zhejiang Hisun Pharmaceutical have adopted recombinant human serum albumin. The project adopts modern biotechnology and uses fermentation to produce recombinant The human ser...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K9/08A61K47/42A61K31/337A61P35/00
Inventor 张文芳
Owner YUANRONG BIOLOGICAL PHARMA WUXI CO LTD
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