A kind of larotaxel water-soluble powder injection and application thereof

A technology of water-soluble powder and larotaxel, which is applied in powder delivery, organic active ingredients, medical preparations of non-active ingredients, etc., and can solve the research on preparations related to nano-polymer micelles of larotaxel that have not been reported. question

Active Publication Date: 2018-07-03
SHANDONG HUBBLE KISEN BIOLOGICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] After patent and literature search, there is no report related to the preparation of larotaxel nano-polymer micelles

Method used

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  • A kind of larotaxel water-soluble powder injection and application thereof
  • A kind of larotaxel water-soluble powder injection and application thereof
  • A kind of larotaxel water-soluble powder injection and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment example 1

[0031] Weigh 180mg carrier material (mPEG 2000 -PDLLA 1700 ) and 20 mg of larotaxel were placed in a round bottom flask, 10 mL of absolute ethanol was added, and the carrier material and the drug were fully dissolved by ultrasonication. The solution was placed in a rotary evaporator at 40° C. for 60 minutes to evaporate the organic solvent completely to obtain a dry and transparent mixed film matrix. Then add 10mL of water for injection preheated at 60°C, hydrate to form micelles under stirring conditions, add mannitol, first pass through a 0.45μm filter membrane for coarse filtration, and then pass through a 0.22μm sterile filter membrane for fine filtration to sterilize, the filtrate freeze-dried to obtain a sample.

Embodiment example 2

[0033] Weigh 150mg carrier material (mPEG 2000 -PCL 2000 ) and 50 mg of larotaxel were placed in a lyophilized bottle, 5 ml of tert-butanol was added, and the carrier material and the drug were fully dissolved by ultrasonication. The solution is lyophilized and the organic solvent is completely removed to obtain a mixed matrix of drug and carrier material. Then add 10mL of water for injection preheated at 60°C, hydrate to form micelles under stirring conditions, add sucrose, first pass through a 0.45μm filter membrane for coarse filtration, and then pass through a 0.22μm sterile filter membrane for fine filtration to sterilize, and the filtrate is frozen Dry to get a sample.

Embodiment example 3

[0035] Weigh 180mg carrier material (mPEG 5000 -PGA 6000 ) and 20 mg of larrotaxel were placed in a round bottom flask, 5 ml of tetrahydrofuran was added, and the carrier material and the drug were fully dissolved by ultrasonication. The solvent was distilled under reduced pressure to completely remove the organic solvent to obtain a dry and transparent mixed film matrix. Then add 10mL of water for injection preheated at 50°C, vortex for 3 minutes, add trehalose, pass the hydration solution through a 0.45 μm filter membrane for coarse filtration, and then pass through a 0.22 μm filter membrane for fine filtration to sterilize, and the filtrate is freeze-dried to obtain sample.

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Abstract

The invention relates to a new generation of taxane drug larotaxel, which is loaded in a carrier auxiliary material to form nano-sized particles, and then freeze-dried to form a powder injection. The carrier auxiliary material is an amphiphilic block copolymer, including a hydrophilic segment and a hydrophobic segment, the hydrophilic segment is polyethylene glycol monomethyl ether, and the hydrophobic segment includes polylactic acid, Polycaprolactone, polyglutamic acid, polytrimethylene carbonate, polymethyl methacrylate, etc. The prepared drug-loaded micelles have high drug-loading capacity, encapsulation efficiency, and stability, and greatly improve the water solubility of the drug; the particle size of the obtained micelles is between 10-100nm, and PEGylation can avoid The recognition and clearance of endothelial phagocytosis system prolongs the circulation in the body and passively targets tumor tissues, thereby improving the curative effect and reducing side effects.

Description

field of invention [0001] The invention relates to the preparation and application of larotaxel water-soluble powder injection, which belongs to the technical field of medicines, and in particular to a preparation method and application of a water-soluble preparation formed by encapsulating larotaxel in a biodegradable carrier material. Background technique [0002] Cancer is a serious threat to human health and the second killer after cardiovascular and cerebrovascular diseases. According to estimates from the American Cancer Society, cancer will become the number one cause of death in the next few years. According to the report of the World Health Organization (WHO), as a country with a large population, with the deterioration of environmental pollution and food safety, the incidence of cancer is extremely serious. [0003] At present, the most commonly used anti-tumor drugs in clinic are taxane compounds, which are widely used in the treatment of breast cancer, cervical c...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/337A61K47/34A61P35/00
CPCA61K9/0019A61K9/19A61K31/337A61K47/34
Inventor 张震谢纪珍王成郭太明董晓玲王秀红董鹏伟
Owner SHANDONG HUBBLE KISEN BIOLOGICAL TECH CO LTD
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