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Paclitaxel injection and preparation method thereof

A kind of injection preparation, technology of paclitaxel

Active Publication Date: 2011-08-17
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The invention provides a preparation method of paclitaxel injection, and the paclitaxel injection produced by the method solves the current toxicity problem of paclitaxel injection in clinical application

Method used

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  • Paclitaxel injection and preparation method thereof
  • Paclitaxel injection and preparation method thereof
  • Paclitaxel injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] ①Take an appropriate amount of absolute ethanol to dissolve the prescribed amount of paclitaxel to obtain solution A;

[0017] ② Take the prescribed amount of polyethylene glycol 15 hydroxystearate and add it to the above solution to obtain solution B;

[0018] ③ Prepare 1% citric acid absolute ethanol solution, adjust the pH of the above solution to between 3.0-5.0 to obtain solution C;

[0019] ④Add absolute ethanol solution to the above solution to the full amount of the preparation solution, stir well to obtain solution D;

[0020] 5. Take solution D, filter by conventional method, fill, sterilize, pack, obtain paclitaxel injection of the present invention.

[0021] In the above steps of the preparation method, in step ⑤, the pH value of the citric acid solution is preferably adjusted to 3.5-4.5.

[0022] Implementation two:

[0023] ①Take an appropriate amount of absolute ethanol to dissolve the prescribed amount of paclitaxel to obtain solution A;

[0024] ② T...

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PUM

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Abstract

The invention belongs to the technical field of medicine, and particularly relates to a paclitaxel injection and a preparation method thereof. The invention provides a paclitaxel injection having stable quality and low toxicity. The paclitaxel injection provided by the invention contains paclitaxel, polyglycol 15-hydroxystearate, anhydrous alcohol and one or more of citric acid, hydrochloric acid, tartaric acid and malic acid. The preferable formula of the paclitaxel injection comprises 5.4-6.6mg / ml paclitaxel, 5-80(V / V) polyglycol 15-hydroxystearate, 20-95%(V / V) anhydrous alcohol and 0.005-0.02%(mg / ml) citric acid.

Description

technical field [0001] The invention belongs to the technical field of medicine, specifically, the invention mainly relates to a paclitaxel injection, and the invention also provides a preparation method thereof. Background technique [0002] Taxol (Paolitaxel, trade name Taxol)) is a diterpenoid component with a unique structure isolated from Taxus brevifolia, and its skeleton is named taxane. Because of its unique pharmacological action and curative effect, it has been paid much attention clinically. On December 29, 1992, the US FDA officially approved paclitaxel as a new anti-tumor drug for the treatment of advanced ovarian cancer. Brode, the director of the American Cancer Society, praised paclitaxel as the most important new anti-tumor drug discovered in the past 15 years. . Since then, people have made great progress in the research on its pharmacological application and drug sources. At present, this product is clinically used for first-line and second-line treatme...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/337A61K47/34A61P35/00A61K47/12
Inventor 杜振新卢秀莲王绍同李大涛张萌
Owner CISEN PHARMA
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