The invention discloses a
paclitaxel alhumin submicron for injection. The
paclitaxel alhumin submicron comprises 1-10% (W / W) of
paclitaxel, 10-80%(W / W) of alhumin and 10-85% (W / W) of freeze-
drying protective agent. The invention also discloses a preparation method of the paclitaxel alhumin submicron. The method comprises the following steps of 1) adding paclitaxel into tert-butyl
alcohol, stirring and dissolving to be used as an organic phase; 2) adding the alhumin and the freeze-
drying protective agent to water or a buffer with a pH within 6.0-8.5, stirring and dissolving to be used as a water phase; 3) adding the organic phase into water with stirring, stirring and dissolving, filtering and degerming through a millipore
filtration method, and placing in a clean container; 4) freezing at-30- -50 DEG C, removing tert-butyl
alcohol and water through freeze-
drying by a lyophilizer to obtain freeze-drying
powder with good profile and loosening quality. During usage, the freeze-drying
powder is added to a
solvent for injection and redissolved, so that paclitaxel alhumin submicrons with an average particle size of 100-600nm are formed. The paclitaxel alhumin submicron for injection ofthe invention has advantages of a simple preparation technology, no high toxic
organic solvent and long-term storage, etc.