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A kind of preparation method of paclitaxel injection resistant to terminal sterilization

A technology for the preparation of injections and paclitaxel, which is applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, anti-tumor drugs, etc., can solve the problems of poor thermal stability of paclitaxel and the inability to terminally sterilize, etc., to prolong the storage time, Prolong storage time and reduce the effect of hydrolysis

Active Publication Date: 2020-08-28
SICHUAN HUIYU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to overcome the disadvantages of poor thermal stability of paclitaxel and incapable of terminal sterilization, provide a preparation method of paclitaxel injection resistant to terminal sterilization, and improve the sterility assurance level of paclitaxel injection

Method used

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  • A kind of preparation method of paclitaxel injection resistant to terminal sterilization
  • A kind of preparation method of paclitaxel injection resistant to terminal sterilization
  • A kind of preparation method of paclitaxel injection resistant to terminal sterilization

Examples

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Embodiment 1

[0032] The preparation method of paclitaxel injection resistant to terminal sterilization of embodiment 1 comprises the following steps:

[0033] (1) Add the prescribed amount of paclitaxel to the prescribed amount of polyoxyethylene (35) castor oil, and stir and shear at a high speed for more than 120 minutes under the condition of a rotation speed ≥ 4000 rpm to obtain solution A; the details are as follows:

[0034] Wash the liquid preparation tank and pipeline with absolute ethanol for 3 times; take the prescribed amount of polyoxyethylene (35) castor oil and add it to the liquid preparation tank; Cut for 120 minutes, dissolve paclitaxel and wrap it into polyoxyethylene (35) castor oil to obtain solution A.

[0035] (2) Add the prescribed amount of absolute ethanol to solution A, and stir until the solution is evenly mixed to obtain solution B;

[0036] (3) Deoxygenate solution B; details are as follows:

[0037] Feed clean nitrogen into solution B until the dissolved oxy...

Embodiment 2

[0041] The preparation method of the paclitaxel injection resistant to terminal sterilization of embodiment 2 comprises the following steps:

[0042] (1) Add the prescribed amount of paclitaxel to the prescribed amount of polyoxyethylene (35) castor oil, and stir and shear at a high speed for more than 120 minutes under the condition of a rotation speed ≥ 4000 rpm to obtain solution A; the details are as follows:

[0043] Wash the liquid preparation tank and pipeline with absolute ethanol for 3 times; take the prescribed amount of polyoxyethylene (35) castor oil and add it to the liquid preparation tank; Cut for 120 minutes, dissolve paclitaxel and wrap it into polyoxyethylene (35) castor oil to obtain solution A.

[0044] (2) Add the prescribed amount of absolute ethanol to solution A, and stir until the solution is evenly mixed to obtain solution B;

[0045] (3) Deoxygenate solution B; details are as follows:

[0046]Pass clean nitrogen into solution B until the dissolved ...

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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.

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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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/44A61K31/337A61P35/00
CPCA61K9/0019A61K9/08A61K31/337A61K47/44A61P35/00
Inventor 刘云龙丁兆胡和平李彬
Owner SICHUAN HUIYU PHARMA
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