A kind of preparation method of docetaxel injection
A technology for docetaxel and injection, which is applied in the field of preparation of docetaxel injection, can solve the problems of loss of medical insurance cost control, untimely use of drugs, waste and the like, and achieves improved solubility, improved medication safety, and is easy to process. The effect of mass production
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[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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