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本文研究了高三尖杉酯碱多相脂质体(代号139—5号)注射液的物理稳定性。提出了研究此类分散物系粒度分布的简便方法即微孔滤膜—光密度法。以此方法研究了139—5号注射液室温及100℃的粒度变化动力学,结果表明,在9个月常温贮存后,体系中大于5μm 粒子小于0.6%;9个月贮存后以及加热100℃12小时后最大粒径不超过16μm。
In this paper, we investigated the physical stability of homoharringtonine multiphasic liposomes (codenamed 139-5). A simple method for studying the particle size distribution of such dispersions is proposed, namely microporous membrane - optical densitometry. The kinetics of particle size variation at room temperature and 100 ℃ of 139-5 injection was studied in this way. The results showed that after 9 months of storage at room temperature, particles larger than 5μm in the system were less than 0.6%. After 9 months of storage and heating at 100 ℃ 12 hours after the largest particle size does not exceed 16μm.