Taxanes medicine preparation for intravenous injection and preparation method thereof

Abstract

The invention relates to the technical field of medicine, which is a preparation of a taxane drug for intravenous drug delivery, consisting of two parts of drug solution and an emulsion. The drug solution is composed of paclitaxel or docetaxel, a pH regulator and a solvent for injection, wherein, the solvent for injection is an organic solvent; the emulsion comprises a fat emulsion and is composed of oil for injection, an emulsifier, an antioxidant, an isotonic regulator, a stabilizer, a pH regulator and water for injection. When in use, the drug solution can be added and evenly mixed in the emulsion for direct intravenous drip according to the clinical drug dosage and can also be firstly added in the emulsion with the volume that is not less than 5 times of the volume of the drug solution according to the clinical drug dosage and then added with a certain amount of physiological saline or glucose injection for intravenous drip. The preparation of the invention does not contain solubilizer and has the advantages of little toxicity, safety, effectivity, stability and economy. The fat emulsion can also be taken as a nutrition replenisher for a patient, thus achieving better treatment effects. The physiological saline or the glucose injection can also replace a certain amount of the emulsion, so the storage and the transportation are convenient, and the preparation is more economical.

Description

technical field

[0001] The invention relates to the technical field of medicine, in particular to an intravenous administration preparation of taxane drugs and a preparation method thereof. Background technique

[0002] Paclitaxel (trade name: Taxo1) and docetaxel (docetaxel, trade name: Taxotem) are two taxane anticancer drugs approved by the FDA. Among them, the natural product paclitaxel is an effective anticancer compound extracted from the bark of the plant Yew brevifolia; docetaxel is a semi-synthesized product from the precursor extracted from the needle leaves of the berry yew.

[0003] Taxanes are a class of typical cytotoxic agents with broad-spectrum antitumor effects. It has a strong inhibitory effect on malignant and metastatic cancer. Its anti-tumor mechanism is to stimulate the polymerization of cathelicidin, promote the assembly of microtubule dimers into microtubules, and make microtubules ultra-stabilized to inhibit the dynamic reorganization of microtubu...

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