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Preparation method of albumin-bound paclitaxel nanoparticles

A technology of albumin-bound paclitaxel, which is applied in the field of preparation of albumin-bound paclitaxel nanoparticles, and can solve the problems of complex process steps and the like

Active Publication Date: 2022-07-01
SICHUAN HUIYU PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] It can be seen that the above scheme involves a large number of large-scale equipment in the process of preparing albumin-bound paclitaxel nanoparticles, and most of the process steps are very complicated.

Method used

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  • Preparation method of albumin-bound paclitaxel nanoparticles
  • Preparation method of albumin-bound paclitaxel nanoparticles
  • Preparation method of albumin-bound paclitaxel nanoparticles

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] 1) Prepare a mixed solvent of 200ml, wherein acetonitrile 180ml, absolute ethanol 20ml;

[0037] 2) Measure 100ml of the above mixed solvent, add 12.0g paclitaxel at room temperature under the state of turning on magnetic stirring and stir until the paclitaxel is completely dissolved;

[0038] 3) Measure 1600ml of water for injection in a beaker, and keep the temperature at 70°C; take 400ml of human albumin and keep it at 58°C, add the human albumin into the water for injection, and keep the temperature at 68°C for 3 minutes;

[0039] 4) The flow rate of the peristaltic pump for adding the paclitaxel solution is set to 250ml / min, and the flow rate of the peristaltic pump for adding the human albumin solution is set to 6L / min. The speed of the disperser (IKA model: 2000-04) is set to 6000rpm, and the peristaltic pump for adding the human albumin solution is turned on. After the human albumin solution enters the disperser, the peristaltic pump for adding the paclitaxel so...

Embodiment 2

[0041] The medicinal solution collected in Example 1 was filled with the capsule filter (after the filtration medicinal solution detected acetonitrile content 22.404 mg / ml; ethanol content 2.014 mg / ml), half plugged, and put into a freeze dryer ( Chutian Technology freeze dryer model: LYO TK 0.5).

[0042] The samples were subjected to the following procedures to remove organic solvents:

[0043]

[0044]

[0045] During the freeze-drying process, there was no bottle spraying phenomenon, and the results of the intervention test in the freeze-drying process showed that:

[0046] Sample 1: run at 5°C and 20mbar for about 1h, ethanol is 22.269mg / ml, acetonitrile is 1.858mg / ml, and the particle size is 145nm;

[0047] Sample 2: run at 5°C and 20 mbar for about 2 hours, ethanol is 22.110 mg / ml, acetonitrile is 1.858 mg / ml, and the particle size is 144 nm;

[0048] Sample 3: run at 5°C and 20 mbar for about 3 hours, ethanol is 22.090 mg / ml, acetonitrile is 1.692 mg / ml, and the...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of albumin-bound paclitaxel nanoparticles. The preparation method of the albumin-bound paclitaxel nanoparticles provided by the invention comprises the following steps: mixing human serum albumin with water, and heating at 60-70 DEG C for 3-10 minutes to obtain a water phase; mixing paclitaxel with an organic solvent to prepare an organic phase; and mixing the organic phase with the water phase, dispersing or emulsifying, filtering, and freeze-drying to obtain the albumin-bound paclitaxel nanoparticles. According to the method, the process route is greatly shortened, the production cost is reduced, the production efficiency is improved, and the product quality can still be guaranteed.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of albumin-bound paclitaxel nanoparticles. Background technique [0002] Albumin-bound drug nanoparticle compositions have been developed as drug delivery systems for the delivery of hydrophobic drugs such as paclitaxel. The albumin-bound drug nanoparticle composition drug delivery system greatly improves the solubility of paclitaxel in the form of albumin-bound paclitaxel, avoids the use of toxic solvents, thereby eliminating the related side effects of toxic solvents and improving safety. [0003] Developed by Celgene Corporation It is the first marketed albumin-bound paclitaxel nanoparticle suspension injection, which was approved by the US FDA in 2005. The currently approved indications are: for the treatment of metastatic breast cancer, non-small cell lung cancer, and in a large number of Clinical trials have shown efficacy in the ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/337A61K47/42A61P35/00
CPCA61K9/19A61K31/337A61K47/42A61P35/00Y02A50/30
Inventor 葛祥军胡和平王云雁丁兆
Owner SICHUAN HUIYU PHARMA