The invention discloses a novel taxol lipid
microsphere injection containing amphiphilic
polyamino acid and a preparation method thereof. The injection contains taxol, amphiphilic
polyamino acid, oil for injection, an emulsifying agent, an auxiliary emulsifying agent, a potential
regulator, an
antioxidant, a
metal chelating agent, an iso-osmotic adjusting agent and water for injection, wherein the amphiphilic
polyamino acid is a segmented
copolymer consisting of a hydrophilic
chain segment and racemic hydrophobic polyamino acid. The novel taxol lipid
microsphere injection represents a microscopic structure different from that of a traditional lipid
microsphere preparation, therefore the injection has excellent stability superior to that of the traditional lipid microsphere preparation. Inthe preparation,
polyoxyethylene castor oil is not contained, VE (
vitamin E) is not used massively, and no
organic solvent is introduced; in addition, the injection can tolerate thermal pressure sterilization, has the advantages of no
irritation,
low toxicity, good stability and low cost, and is suitable for industrial production in large scale.