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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。
In this paper, we investigated the important physicochemical properties, rheology, charge, conductivity and phase transition temperature of multi-phase liposome 139 injection and found that the conductivity of the multiphase liposome 139 is sensitive to the dispersion of the multiphase dispersion. Therefore, the law of dispersion of the system was designed by the conductivity method, and its aggregation velocity equation and cohesion activation energy were obtained. The variation of the dispersion degree of the heterogeneous dispersion system, that is, the aggregation of dispersed particles, was described and the aggregation rate constants were obtained. The physical stability of such heterogeneous dispersions can be quantitatively evaluated. In this paper, the physical stability, particle size distribution and particle size changes of multiphase liposome 139 injection were measured by the Coulter Counter and Coulter Counter. The composition of multiphase liposomes was confirmed by microscopy . Determination of data that 139 injection meets the requirements of intravenous injection. Conductance method is reliable, simple and easy. In this paper, a new method for determining the phase separation temperature of multiphase disperse system by conductivity-temperature curve is also proposed.