Objective To establish a sterility test method of docetaxel micelles for injection.Methods The method was established according to the general principles 1105 of Chinese Pharmacopoeia (2015 edition). 15 bottles of docetaxel micelles for injection were dissolved in 500 mL 0.9% sodium chloride solution. The prepared solution was filtrated to three filter cartridges at equal volume. Other three filter cartridges were prepared by the same method. Each filter cartridge was rinsed with pH 7.0 sterile sodium chloride-peptone buffer solution for three times (100 mL each time). Staphylococcus aureus, escherichia coli, bacillus subtilis, candida albicans, clostridium sporogenes and aspergillusniger with a content less than 100 CFU/mL was respectively added in the last rinse. Then the corresponding culture medium was added and the cartridges were cultured at a suitable temperature. The same follow-up procedure was performed for the control group, in which the same amount of sterile sodium chloride solution was substituted for the test solution of docetaxel for injection. The growth of each strain was detected.Results All the six strains grew well within 48 h under suitable temperature. The antibacterial activities of the samples were completely eliminated.Conclusion The sterility test of docetaxel micelles for injection could be assayed by the established method.