PREPARATIONS OF TAXANES FOR INTRAVENOUS ADMINISTRATION AND THE PREPARATION METHOD THEREOF

摘要

The invention relates to a preparation of taxanes for intravenous administration consisting of a drug solution and an emulsion. The drug solution consists of paclitaxel or docetaxel, a pH regulator and an organic solvent for injection. The emulsion includes 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 used, the drug solution at the clinical dosage can be added and evenly mixed in the emulsion to perform intravenous drip directly; or the drug solution at the clinical dosage can also be firstly added into the emulsion with no less than 5 times volume of the drug solution and then a predetermined amount of normal saline or glucose solution for injection is added to perform intravenous drip. The preparation of the present invention does not contain solubilizer.

主权项

1. A drug solution of taxanes for intravenous administration, wherein the drug solution consists of paclitaxel or docetaxel at 0.01 to 10% (w/v), a pH regulator in an amount sufficient to adjust the pH of the drug solution to a pH of 4.0 to 7.0, with the balance of a solvent for injection,
wherein the solvent for injection is selected from one or more of PEG-200, PEG-300; PEG-400, PEG-600, propylene glycol, glycerol and anhydrous ethanol; wherein the pH regulator is selected from one or more of citric acid, malic acid, hydrochloric acid, acetic acid, sodium carbonate, sodium bicarbonate and sodium hydroxide.