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Lipid microsphere, lyophilized lipid microsphere containing docetaxel and preparation process thereof

A technology of docetaxel and lipid microspheres, which is applied in the directions of non-active ingredient medical preparations, liposome delivery, pharmaceutical formulations, etc., can solve the problems of inconvenient medication, low solubility, and poor patient compliance. Facilitate clinical application and improve solubility

Inactive Publication Date: 2007-05-23
金耀
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The purpose of the invention is to overcome the deficiencies of the prior art, solve the technical problems of docetaxel instability, extremely low solubility, large adverse reactions in medication and poor patient compliance, and also solve the concentration of docetaxel preparations in the prior art. Low, inconvenient drug use in clinical practice and inconvenient storage and transportation

Method used

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  • Lipid microsphere, lyophilized lipid microsphere containing docetaxel and preparation process thereof
  • Lipid microsphere, lyophilized lipid microsphere containing docetaxel and preparation process thereof
  • Lipid microsphere, lyophilized lipid microsphere containing docetaxel and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0084] Prescription composition:

[0085] Docetaxel 10g

[0086] VE 100g

[0087] Phospholipids 25g

[0088] Oleic acid 50g

[0089] PEG400 25g

[0090] Sucrose 50g

[0091] Disodium EDTA 0.05g

[0092]Add water for injection to 1000ml

[0093] Precisely weigh the raw and auxiliary materials; under the condition of nitrogen protection, add docetaxel, PEG400, oleic acid, VE, phospholipids, into the oily ingredient preparation tank, stir until they are all dissolved, and keep the solution temperature at 50°C to obtain Oil phase; add the prescribed amount of sucrose and disodium EDTA, and a certain amount of water for injection into the water phase preparation tank, stir and dissolve to keep the solution temperature at 50°C to obtain the water phase; add the water phase solution to the high-speed shear In the cutting equipment, slowly add the oil phase solution to the stirring water phase, keep the temperature at 45°C, stir and shear for 15 minu...

Embodiment 2

[0147] Prescription composition:

[0148] Docetaxel 10g

[0149] VE 100g

[0150] Phospholipids 25g

[0151] Oleic acid 50g

[0152] PEG400 25g

[0153] Sucrose 50g

[0154] Disodium EDTA 0.05g

[0155] Mannitol 100g

[0156] Glycine 20g

[0157] Add water for injection to 1000ml

[0158] Precisely weigh the raw and auxiliary materials; under the condition of nitrogen protection, add docetaxel, phospholipids, PEG400, oleic acid, and VE into the oily ingredient preparation tank, stir until completely dissolved, and keep the solution temperature at 50°C to obtain oil phase; add the prescribed amount of sucrose and disodium EDTA, and a certain amount of water for injection into the water phase preparation tank, stir, dissolve and keep the solution temperature at 50°C to obtain the water phase; add the water phase solution to the high-speed shear In the equipment, slowly add the oil phase solution to the stirring water phase, keep the...

Embodiment 3

[0161] Prescription composition:

[0162] Docetaxel 2g

[0163] VE 80g

[0164] Phospholipids 20g

[0165] Polyoxyethylene castor oil 30g

[0166] Add water for injection to 1000ml

[0167] The preparation method was the same as in Example 1 to prepare docetaxel lipid microspheres.

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Abstract

The invention relates to a liposome micro-sphere agent with Doxitasa, and dry liposome micro-sphere, wherein the mass density of Doxitasa is 1-40mg / ml; the liposome micro-sphere component comprises Doxitasa, oil component, emulsifier, and injection water, to be prepared into vein injection. The invention also provides a relative Doxitasa dry liposome micro-sphere agent, with high load, high packing rate, better stability, and little side effect, which can be stored and transmitted easily, with target property. The inventive agent supports batch production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations. Specifically, the invention relates to a lipid microsphere containing docetaxel, a freeze-dried lipid microsphere and a preparation method. Background technique [0002] Docetaxel (Docetaxel / Taxotere, docetaxel) was developed by Rhone Poulenc Rorer (now Sanofi-Aventis) in France, and has been used in China, the United States, Japan and other countries. Nearly 100 countries in the world have listed on the market one after another. [0003] Docetaxel is a class of taxanes that inhibit tumor cell differentiation by essentially "freezing" the cell's intrinsic cytoskeleton. The cytoskeleton is composed of microtubules, which assemble and disassemble at appropriate times during the cell cycle. Docetaxel can promote microtubule assembly and prevent microtubule disassembly, thereby inhibiting tumor cell differentiation and ultimately leading to tumor cell death (Fulton B. Spencer CM...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/337A61K9/127A61K9/16A61K47/44A61K47/36A61K47/34A61K47/26A61K47/24A61K47/14A61P35/00A61K47/10
Inventor 金耀谭梓骏王昶
Owner 金耀
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