Non-predissolved Docetaxel injection

Abstract

The invention relates to a non-predissolved Docetaxel injection. The non-predissolved Docetaxel injection is prepared by the following method comprising the steps of dissolving citric acid and sodiumcitrate in anhydrous ethanol, sequentially adding Docetaxel, polysorbate 80 for injection and activated carbon for injection with stirring, carrying out stirring and mixing to achieve thorough dissolving after charging is completed, carrying out decarbonization filtration with a titanium bar filter, sterilization filtration with a polytetrafluoroethylene microporous filtration film and filtrationwith a common microporous filtration film sequentially, then, loading filtrate into penicillin bottles, and carrying out cap pressing, capping, labeling and packaging. According to the non-predissolved Docetaxel injection, a proton supplying buffer agent anhydrous ethanol solution prepared from citric acid and sodium citrate is adopted, thus, the solution can basically keep a constant pH(power ofhydrogen) value, and the change of related substances is not obvious along with variance in temperature and time; the problem that Docetaxel injections are poor in solubility and poor in stability issolved, and the non-predissolved Docetaxel injection can be preserved and transported at normal temperature, has no need of predissolving during use and can be prepared instantly; and the number of procedures is few, and the process flow is short.

Description

technical field [0001] The invention relates to a non-predissolved docetaxel injection. Background technique [0002] Many poorly soluble and insoluble drugs cannot be dissolved immediately after being added to the solvent for injection. It is necessary to add a specific solvent in advance, or pre-dissolve by heating, shaking, ultrasound, etc., and then dilute it for clinical use. [0003] The existing docetaxel injection is packaged in two bottles, one bottle is composed of docetaxel and polysorbate 80, and the other bottle is composed of 95% ethanol and water for injection. The preparation process of docetaxel injection is as follows: adding docetaxel to polysorbate 80, adding a certain amount of organic solvent to dilute, filtering and sterilizing, freezing or decompression to remove the organic solvent, and filling. A concentrated solution is obtained; a special solvent (13% ethanol) is prepared by preparing, sterilizing, and filling with 95% ethanol for injection and w...

AI Technical Summary

Problems solved by technology

[0005] CN1850056A discloses a docetaxel freeze-dried powder injection and its preparation method, which provides a more convenient clinical use and more stable docetaxel freeze-dried powder injection, but its disadvantage is that a large amount of Solvents and preparation auxiliary materials, industrial freeze-drying production consumes a lot of energy and takes a long time, and needs to be reconstituted and diluted before use, which increases the possibility of bacterial contamination

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