Quality Standard of Mitomycin Nanoparticles for Injection / 中国药房

ABSTRACT

OBJECTIVE: To establish a quality control method for mitomycin nanoparticles(MMC-PBCA-NP) for injection.METHODS: The appearance of nanoparticles was observed by transmission electron microscope(TEM),and its particle size and particle size distribution were measured using Marvin Laser granulometer.The content of MMC in the nanoparticles was determined by HPLC.The related quality test of 3 batches of samples were performed in accordance with the quality standard of injections stated in the appendix of Chinese Pharmacopeia(2005 Edition),and investigate the preliminary stability of the preparation.RESULTS: The preparation was purplish pultaceous cake substance,and the drug-loading nanoparticles were globular in appearance,with the average particle size,the average encapsulation efficiency and the drug loading amount at 100.0 nm,85.8% and 7.0 %,respectively,all in conformity with the standard stated in Chinese Pharmacopoeia.The preliminary stability of the preparation was good.CONCLUSION: The quality standard study on which serves as quality references for its industrialized production.