Docetaxel combination for injection and preparation method thereof

Abstract

The invention relates to a Docetaxel combination for injection, which comprises the following components by mass ratio: 1 part of Docetaxel and 26.75 parts of polysorbate 80, wherein absolute alcohol is used as solvent in the preparation. The preparation method thereof comprises the following steps: 1) preparing mother liquid: adding polysorbate 80 to a liquid preparation tank and slowly adding absolute alcohol while stirring until the density of the mother liquid reaches 0.886g / ml to 0.896g / ml according to a hydrometer; 2) dissolving Docetaxel in the mother liquid; 3) carrying out sterile filtration, split-charging and partially stoppering; and 4) vacuum-drying, removing alcohol, stoppering, decrating and tying by aluminum-plastic composite covers stage by stage, and packaging upon qualification to obtain the Docetaxel combination for injection.

Description

technical field

[0001] The invention relates to a docetaxel composition for injection and a preparation method thereof, and the docetaxel composition prepared by the method can be used for the treatment of non-small cell lung cancer. Background technique

[0002] Docetaxel is a semi-synthetic paclitaxel derivative developed by Rhone-Poulenc Rorer. It is a microtubule depolymerization inhibitor that promotes the polymerization of tubules into stable microtubules. And inhibit its depolymerization so that the number of free tubules is significantly reduced. It was launched in Mexico for the first time in April 1995, and was subsequently launched in major countries such as the United Kingdom, the United States, France, Italy, Germany, and Japan. It is used for advanced and metastatic breast cancer that has failed or recurred after anthracycline antineoplastic drugs and non-small cell lung cancer that has not responded to treatment. The recommended dosing regimen is once every ...

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