抗癌药物新剂型—多相脂质体的研究——多相脂质体139注射液物理稳定性的研究

本文研究了多相脂质体139注射液重要的物化性质,流变性、荷电、导电性和相变温度,发现其电导率随多相分散体系分散度的变化比较敏感。因此设计了电导法测定体系分散度变化规律,得出其凝聚速度方程,凝聚活化能,描述了此类多相分散系分散度变化即分散微粒凝聚的规律,并求得凝聚速度常数,这些数据可定量地评价此类多相分散系的物理稳定性。本文利用电导法和库尔特计数器(Coulter Counter)测定了多相脂质体139注射液的物理稳定性、粒度分布和粒径变化规律,并由显微镜照像证实了多相脂质体的组成。测定数据说明139注射液符合静脉注射剂的要求。电导法可靠,简便易行。本文还提出了利用电导—温度曲线测定多相分散系相分离温度的新方法。

AN INVESTIGATION OF POLYPHASE LIPOSOME-A NEW DOSAGE FORM ANTITUMOR AGENTS Ⅴ.THE STUDIES ON THE PHYSICAL STABILITY OF THE INTRAVENOUS INJECTION OF POLYPHASE LIPOSOME(139)IN THE FORM OF SUSPENSION

In this report,a study is presented on physical stability of the injection(139),it was observed in those tests that the condu- ctivity of the injection(139)was rather sensitive to coalescence of polyphase liposome.Therefore,by measuring the regularity of the conductivity change in the injection(139),the physical st- ability in the polyphase dispersive system might be obtained.us- ing the method,the kinetic equation of coalescence of polyphase liposome in the injection(139)might be derived,which stated the change of dispersion degree,i.e.change of coalescence in the type of polyphase disporsion system;and the activity energy for coal- escence and the kinetic constants of coalescence of the dispersive particles in the injection(139)might be derived. Meanwhile,in our study of the physical stability of the injec- tion(139),The distribution of particle size and the change rule of particle size were determined with“Coulter Counter”,and by the microscopic photographs the constitution of polyphase liposome was verified。