PACLITAXEL COMPOSITION FOR INJECTION WITH IMPROVED STABILITY

摘要

PURPOSE: A paclitaxel composition for injection with improved stability is provided, which shows lower toxicity and better stability than existing paclitaxel composition for injection(that uses polyethoxylated castor oil 35 as the solubilizer). CONSTITUTION: A process for the preparation of paclitaxel composition for injection with improved stability comprises of: preparing (oxyethylene)60 sorbitol tetraoriet 10ml by heating(A); mixing (ethyleneglycol)15 monooriet 10ml and polyethyleneglycol 300(average molecular weight is 300)(B); mixing and dissolving A and B, and dissolving while shaking after adding anhydrous ethanol 20ml; dissolving the paclitaxel 300mg and povidone 800mg in small quantity of anhydrous ethanol, adding to the mixed solubilizer, and dissolving while shaking with the Homogenizer mixer; sterilization-filtering with 0.2micro filter; and packaging by nitrogen-packing to get the objective paclitaxel composition for injection.