阿克拉霉素B毫微粒的稳定性研究

Stability of Aclacinomycin B Nanoparticles (ACMB NP) in Lyophilization Injection

考察了以药物阿克拉霉素 B(ACMB)为主体形成的毫微粒 (NP)的物理、化学稳定性。以电镜扫描方法考察微粒外观 ,对所采集的图像进行粒径分析统计 ;建立 ACMB- NP冻干剂的 HPL C含量测定方法 ,以考察其化学稳定性。经 3个月常规稳定性试验 ,ACMB- NP的外观、粒径、冻干样品的成形率、p H、含量均未发生明显的变化 ;经典恒温加速实验预测的常温下有效期为 40 .74年。光加速降解研究表明 ,光分解发生在毫微粒表面 。

The physical and chemical stabilities of aclacinomycin B nanoparticles (ACMB NP) was investigated. The method to determine the content of ACMB in the ACMB NP lyophilization injection by HPLC was developed. Each of indexes for ACMB NP lyophilization injection, such as appearance, particle size (measured by scanning electron microscope), forming rate, pH and ACMB content had not changed notably at 40 °C 75% RH for three months. The calculated expiration date of the ACMB NP lyophilization injection at 25 °C was 40.74 years with the classical constant temperature accelerated test. ACMB NP lyophilization injection was instable under the light source of 4000 lx and the decomposition caused by light took place on the surface of ACMB NP.