Preparation method of paclitaxel injection resistant to terminal sterilization

A technology for preparing injection and paclitaxel, which is applied in the field of preparing paclitaxel injection and the preparation of paclitaxel injection resistant to terminal sterilization, can solve the problems of inability to terminal sterilization and poor thermal stability of paclitaxel, and achieves prolonged storage time, The effect of prolonging the storage time and avoiding the degradation of substances
CN110123745AActive Publication Date: 2019-08-16SICHUAN HUIYU PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
SICHUAN HUIYU PHARMA
Publication Date
2019-08-16

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Abstract

The invention relates to a preparation method of paclitaxel injection resistant to terminal sterilization, belonging to the technical field of pharmaceutical preparations. The preparation method of the paclitaxel injection comprises the following steps: (1) adding a prescribed amount of paclitaxel into a prescribed amount of polyoxyethylene (35) castor oil, and stirring and shearing at a high speed; (2) adding a prescribed amount of absolute ethanol into the solution, stirring until the solution is mixed evenly, and deoxidizing; (3) sterilizing and filtering the solution obtained in the step (2), filling and deoxidizing, sealing, and carrying out high temperature sterilization. The preparation method of the paclitaxel injection enables the paclitaxel to be wrapped by the polyoxyethylene (35) castor oil by changing a feeding sequence, so that the material degradation and decomposition of the paclitaxel can be reduced in a terminal sterilization process, and the finally obtained paclitaxel injection is good in quality and high in stability.
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Description

technical field

[0001] The invention relates to a method for preparing paclitaxel injection, in particular to a method for preparing paclitaxel injection resistant to terminal sterilization, and belongs to the technical field of pharmaceutical preparations. Background technique

[0002] Paclitaxel is an antineoplastic drug extracted from Taxus chinensis. It has a unique mechanism of action, by inducing and promoting tubulin polymerization, assembly and stabilizing microtubules, preventing the growth of tumor cells, and has curative effects on ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer and prostate cancer Significantly, it is a broad-spectrum anticancer drug. Paclitaxel and its injection were first developed by Bristol-Myers Squibb Company. In 1992, it was approved by FDA to enter the US market for the first time, and it has been widely used in the world.

[0003] Due to the complex structure of paclitaxel, it is unstable to heat, alkali...

Claims

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