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Preparation method of docetaxel injection

A technology for docetaxel and injections, applied in the field of preparation of docetaxel injections, which can solve the problems of medical insurance cost control loss, untimely use of medicines, waste, etc., to achieve improved solubility, improved drug safety, and easy process The effect of mass production

Active Publication Date: 2017-09-15
SICHUAN HUIYU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This brings a lot of inconvenience to clinical use, and it is very likely that the diluted medicine cannot be used in time, resulting in waste and causing great losses to the national medical insurance control fee.

Method used

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  • Preparation method of docetaxel injection
  • Preparation method of docetaxel injection
  • Preparation method of docetaxel injection

Examples

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preparation example Construction

[0023] The invention discloses a preparation method of docetaxel injection, and those skilled in the art can learn from the content of this article and appropriately improve the process parameters to realize it. In particular, it should be pointed out that all similar replacements and modifications are obvious to those skilled in the art, and they are all considered to be included in the present invention. The method and application of the present invention have been described through preferred embodiments, and the relevant personnel can obviously make changes or appropriate changes and combinations to the method and application described herein without departing from the content, spirit and scope of the present invention to realize and Apply the technology of the present invention.

[0024] The docetaxel injection provided by the present invention is prepared from docetaxel as an active ingredient, polysorbate 80 as a solubilizer, absolute ethanol as a solvent, and anhydrous ...

Embodiment 1

[0031] Embodiment 1 (the time that docetaxel is added at a uniform speed is 15min):

[0032] prescription:

[0033]

[0034] Process:

[0035] 1) Add an appropriate amount of citric acid into the polysorbate 80 solution, and stir until completely dissolved;

[0036] 2) Add the prescribed amount of docetaxel to the solution obtained in step (1), and start stirring while adding. Control the adding speed of docetaxel, make the time of its uniform speed adding be 15min, promptly the adding speed of docetaxel is 0.53g / min;

[0037] 3) After the step (2) is completed, add an appropriate amount of absolute ethanol solution, mix well, and then pass through a 0.22 μm filter element for sterilization and filtration, and then fill and cap to obtain the docetaxel injection.

Embodiment 2

[0038] Embodiment 2 (the time that docetaxel is added at a uniform speed is 30min):

[0039]

[0040] Process:

[0041] 1) Add an appropriate amount of citric acid into the polysorbate 80 solution, and stir until completely dissolved;

[0042] 2) Add the prescribed amount of docetaxel to the solution obtained in step (1), and start stirring while adding. Control the adding speed of docetaxel, the time that makes its uniform speed adding is 30min, promptly the adding speed of docetaxel is 0.27g / min;

[0043] 3) After the step (2) is completed, add an appropriate amount of absolute ethanol solution, mix well, and then pass through a 0.22 μm filter element for sterilization and filtration, and then fill and cap to obtain the docetaxel injection.

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Abstract

The invention relates to the field of drug preparations, in particular to a docetaxel injection and a preparation method thereof. The docetaxel injection diluted to the clinical application concentration with a 5% glucose solution or a 0.9% sodium chloride solution can be stored for a long time without separating out precipitations. With the adoption of the preparation method, the defects that docetaxel diluted to the clinical application concentration with the 5% glucose solution or the 0.9% sodium chloride solution is poor in stability and likely to separate out precipitations and cannot be stored for a long time are overcome, and the medicinal safety is improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of docetaxel injection. Background technique [0002] Docetaxel is a paclitaxel antineoplastic drug, which prevents the rapid division of cancer cells by promoting the aggregation of microtubules and preventing the normal physiological depolymerization of microtubules, stopping them in the G2 phase and M phase until death . Whether used alone or in combination with other drugs, it has shown good efficacy in the treatment of various solid tumors (breast cancer, non-small cell lung cancer and prostate cancer, etc.). [0003] Docetaxel Injection It was first listed in Mexico in April 1995, listed in the European Union in November, approved by FDA in 1996, and approved for import in my country in 1997. It is currently approved for sale in nearly 100 countries or regions including China, Europe, the United States, and Japan. A generic drug was launche...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/337A61P35/00
CPCA61K9/0019A61K9/08A61K31/337
Inventor 杨立开丁兆任永春王爱丽胡和平张吉旺
Owner SICHUAN HUIYU PHARMA
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