注射用丝裂霉素纳米粒质量标准研究

目的:建立注射用丝裂霉素纳米粒(MMC-PBCA-NP)的质量标准。方法:采用透射电镜观察纳米粒形态,马尔文激光粒度分析仪测定粒径及分布,高效液相色谱法测定纳米粒中MMC含量,依据2005年版《中国药典》附录注射剂的规定对3批样品进行相关质量检查,并考察制剂初步稳定性。结果:本品为浅紫色疏松饼状物,载药纳米粒外观为圆球形,平均粒径、包封率和载药量分别为100.0nm、85.8%、7.0%,各检查项目均符合《中国药典》的有关规定,初步稳定性良好。结论:所建质量标准可为该制剂工业化生产提供质量检验依据。

Quality Standard of Mitomycin Nanoparticles for Injection

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 nanopartitles 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.