Docetaxel injection and preparation method thereof

Abstract

The invention relates to a docetaxel injection. The docetaxel injection is prepared from docetaxel, lipoic acid, medicinal absolute ethyl alcohol and polyethylene glycol stearate. The lipoic acid is added into the docetaxel injection, and stability of double bonds in the docetaxel is facilitated. In addition, the lipoic acid has the anti-oxidation effect and can slow down product degradation. In the injection preparation process, compared with an existing technology, the medicinal absolute ethyl alcohol is not removed. During clinical use, the step of adding ethyl alcohol for dilution is omitted, and use is safer, more convenient and faster. The four components in the injection are compounded for use, the docetaxel injection meets the USP35 docetaxel injection standard within the two-year life time, and the clinical application is safer.

Description

technical field [0001] The invention relates to the technical field of injections, in particular to a docetaxel injection and a preparation method thereof. Background technique [0002] Docetaxel injection is suitable for the treatment of advanced or metastatic breast cancer that failed prior chemotherapy, and docetaxel injection is also suitable for the treatment of advanced or metastatic non-small cell lung cancer that failed cisplatin-based chemotherapy. Docetaxel injection is for intravenous infusion only. [0003] The excipients used in commercially available products of docetaxel injection are citric acid and Tween 80, and use citric acid to adjust the pH value of docetaxel injection to 3-4.5; the solvent of commercially available products is medicinal Absolute ethanol, and in the preparation process of docetaxel injection, the method of first removing absolute ethanol and then sterilizing is adopted. [0004] Tween 80 has a stimulating effect on the human body, whic...

AI Technical Summary

Problems solved by technology

[0004] Tween 80 has a stimulating effect on the human body, which is likely to cause adverse reactions, and is not safe for clinical use; in addition, the commercially available finished product does not contain absolute ethanol, and in clinical use, it is necessary to dilute the drug with absolute ethanol solution before adding The human body can only be infused with glucose solution or normal saline, which is cumbersome to operate and increases the risk of drug contamination

In addition, commercially available products all use filter sterilization method, which is risky

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