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Docetaxel injection and preparation method thereof

A technology for docetaxel and injection, which is applied in the field of novel preparation of docetaxel injection, can solve the problems of limited clinical application and the exertion of good efficacy, complicated preparation method, poor stability and the like, and is suitable for mass preparation and industrialization. The production and preparation methods are simple and easy to implement, and the clinical use is convenient.

Inactive Publication Date: 2008-06-04
JIANGSU TASLY DIYI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Taxotere has complex preparation methods for clinical use, poor stability, inconvenient production, storage, transportation, carrying and use, and expensive preparation products, which limit its clinical application and good drug efficacy

Method used

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  • Docetaxel injection and preparation method thereof
  • Docetaxel injection and preparation method thereof
  • Docetaxel injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 Preparation of Novel Docetaxel Injection

[0031] Weigh 12 grams of soybean lecithin for injection, heat and stir with 30 milliliters of absolute ethanol to dissolve, add 50 grams of Tween-80, mix well, add docetaxel (Shanghai Junjie Biotechnology Co., Ltd., specification: 99.6%, batch No: JJ0512#2) 1000mg, heat and stir to dissolve, add absolute ethanol to 100ml, filter, subpackage, and sterilize.

Embodiment 2

[0032] Example 2 Preparation of Novel Docetaxel Injection

[0033] Weigh 12 grams of soybean lecithin for injection, heat and stir with 30 ml of absolute ethanol to dissolve, add 50 g of Tween-80, mix well, add 600 mg of docetaxel, heat and stir to dissolve, add absolute ethanol to 100 ml, filter , subpackage, and sterilize.

Embodiment 3

[0034] Example 3 Preparation of Novel Docetaxel Injection

[0035] Measure 30 ml of absolute ethanol, add 15 g of soybean lecithin for injection, 1.66 g of cholesterol, 50 g of Tween-80 and stir to dissolve, add 800 mg of docetaxel, stir until dissolved, add absolute ethanol to 100 ml, filter , subpackage, and sterilize.

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PUM

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Abstract

The invention relates to the technical field of medicine, in particular to a novel preparation method of docetaxel injection. The prescription of the docetaxel injection of the invention consists of docetaxel, stabilizing agent and menstruum used for injection. The preparation method includes the following steps: (1) the stabilizing agent of a prescription amount is dissolved in the menstruum of the prescription amount used for injection; (2) the docetaxel of the prescription amount is dissolved in the solution obtained in the step (1); and then filtering, sub-package and sterilization are carried out to finish the preparation. The docetaxel injection of the invention has better stability and convenient use.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a novel preparation method of docetaxel injection. Background technique [0002] Docetaxel (docetaxel, trade name Taxotere) is a semi-synthetic paclitaxel derivative with molecular formula C 13 h 53 NO.3H 2 o, molecular weight 861.9. The product was first launched in Mexico in April 1995, and is now available in Britain, the United States, France, Italy, Germany, Japan and other countries. Docetaxel can accelerate the polymerization of tubulin into microtubules and delay the depolymerization of microtubules, resulting in the formation of stable non-functional microtubule bundles, thereby disrupting mitosis and cell proliferation. Its cytotoxic effect is 1.3-12 times that of paclitaxel; the intracellular drug concentration is 3 times that of paclitaxel; the intracellular retention time is 3 times that of paclitaxel. [0003] Docetaxel has anticancer activity against a variet...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/337A61K9/08A61K47/24A61K47/14A61K47/34A61P35/00A61K47/10A61K47/26
Inventor 陈建明张广明叶正良
Owner JIANGSU TASLY DIYI PHARMA CO LTD
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