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Docetaxel nano-particle composition

A docetaxel and nanoparticle technology, applied in the directions of drug combination, drug delivery, organic active ingredients, etc., can solve the problems of health hazards, high price, and low negative phospholipid content in patients with cardiovascular and cerebrovascular diseases, and improve drug safety. , low price, high encapsulation rate

Inactive Publication Date: 2010-06-16
CHIA TAI TIANQING PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, pharmaceutical preparations containing more cholesterol may bring harm to the health of patients, especially those with cardiovascular and cerebrovascular diseases.
In addition, negative phospholipids are used in some liposomes, but the content of negative phospholipids in natural phospholipids is very small, the price is relatively high, and there is no pharmaceutical grade in China, which limits its clinical application

Method used

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  • Docetaxel nano-particle composition
  • Docetaxel nano-particle composition
  • Docetaxel nano-particle composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Prescription: Docetaxel 1g

[0037]Hydrogenated Soy Lecithin 70g

[0038] 0.01NpH6.5 phosphate buffer (sodium dihydrogen phosphate or??, should be specific) 870ml

[0039] Preparation Process:

[0040] 1. Dissolve the prescription amount of docetaxel and hydrogenated soybean lecithin in 80ml of ethanol as the organic phase;

[0041] 2. Take 870ml of 0.01N pH6.5 phosphate buffer, heat it to 65°C and use it as the water phase;

[0042] 3. Slowly inject the organic phase into the water phase under nitrogen protection and stirring, and stir thoroughly for 30 minutes to obtain the nanoparticle suspension;

[0043] 4. Pass the nanoparticle suspension into a high-pressure homogenizer to homogenize for 5 times, then sterilize and filter, and pack aseptically.

Embodiment 2

[0045] Prescription: Docetaxel 1g

[0046] Egg yolk lecithin 30g

[0047] Sucrose 60g

[0048] Preparation Process:

[0049] 1. Dissolve the prescription amount of docetaxel and egg yolk lecithin in 22ml of ethanol as the organic phase;

[0050] 2. Take the prescribed amount of sucrose, add 230ml of water for injection to dissolve it as the water phase;

[0051] 3. Heat the water phase to 40°C at a constant temperature, slowly inject the organic phase into it under nitrogen protection and stirring, and shear for 30 minutes to obtain the nanoparticle suspension;

[0052] 4. Pass the nanoparticle suspension into a high-pressure homogenizer for homogenization 5 times, sterilize and filter, divide into vials for freeze-drying, and pack.

Embodiment 3

[0054] Prescription: Docetaxel 1g

[0055] Hydrogenated Soy Lecithin 25g

[0056] Soy Lecithin 15g

[0057] Maltose 45g

[0058] Preparation Process:

[0059] 1. Dissolve the prescription amount of docetaxel, hydrogenated soybean lecithin and soybean lecithin in 35ml ethanol as the organic phase;

[0060] 2. Take the prescribed amount of maltose, add 450ml of water for injection to dissolve it as the water phase;

[0061] 3. Heat the water phase to 70°C at a constant temperature, slowly inject the organic phase into it under nitrogen protection and stirring, and then shear for 20 minutes to obtain the nanoparticle suspension;

[0062] 4. Pass the nanoparticle suspension into the extruder and extrude it for 6 times, then sterilize and filter, put it into vials for freeze-drying, and pack.

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Abstract

The invention relates to a docetaxel nano-particle composition for injection administration and a preparation method thereof. The docetaxel nano-particle composition contains neutral phospholipid and docetaxel, and does not contain negative phospholipid and cholesterol.

Description

technical field [0001] The invention relates to a composition which can be used for injection administration and a preparation method thereof, in particular to a docetaxel nanoparticle composition which can be used for injection administration and a preparation method thereof. Background technique [0002] Docetaxel (docetaxel, docetaxel) is a taxane compound, which can be obtained by semi-synthesis from the non-cytotoxic precursor compound 10-deacylated baccatin II extracted from Taxus chinensis, 1998 Approved by the US FDA for marketing, it is currently the most effective taxane anticancer agent in clinical use. Since its launch, it has been widely used in the treatment of various cancers, including prostate cancer, breast cancer, lung cancer, gastric cancer, head and neck tumors, etc. At present, docetaxel has become one of the most widely used cytotoxic drugs in the treatment of solid tumors. The main indications for marketed docetaxel are locally advanced or metastati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/19A61K31/337A61P35/00
Inventor 张喜全张来芳程艳菊
Owner CHIA TAI TIANQING PHARMA GRP CO LTD
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