RESUMEN
OBJECTIVE: To prepare Mitomycin C for injection-Polybutylcyanoacrylate Nanoparticles (MMC-PBCA-NPs) freeze drying preparation by microfluidization and to investigate its hemolytic feature. METHODS: The crude emulsion of MMC-PBCA-NPs was prepared by emulsion polymerization method, from which MMC-PBCA-NPs solution was prepared by microfluidization method; the encapsulation efficiency (EE) and the drug loading (DD) of the preparation were detected by ultraviolet spectrophotometry. The particle size and appearances of which were observed. A hemolytic test was performed on rabbits to observe the blood reaction of the preparation. RESULTS: The prepared MMC-PBCA-NPs freeze drying preparation was uniformly distributed and in round shape, with EE, DD and mean diameter at (85.1?3.8)%, (7.0?0.2)% and (113.5?3.86)nm, respectively. The hemolytic test was negative. CONCLUSION: It is feasible to prepare MMC-PBCA-NPs by microfluidization method.
RESUMEN
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.