处方因素对亚微乳物理稳定性的影响
Study on the influence of formulation factors on the physical stability of submicron emulsion
作者：张娜;储婷;张青;马伟从;金辉;毛声俊;
Author：
收稿日期： 年卷（期）页码：2012,27(04):-391-394
期刊名称：华西药学杂志
Journal Name：WEST CHINA JOURNAL OF PHARMACEUTICAL SCIENCES
关键字：亚微乳;乳化剂;油相;稳定性
Key words：
基金项目：
中文摘要
目的初步探讨亚微乳处方中乳化剂及油相因素对其物理稳定性的影响。方法采用高速剪切分散和高压均质乳化工艺制备亚微乳,单因素试验法考察处方中乳化剂与油相对亚微乳物理稳定性的影响;以平均粒径、D50值、D99值及ζ电位为指标,考察不同处方中亚微乳灭菌前后的物理稳定性,并留样观察其长期稳定性。结果泊洛沙姆188与中链油相互配伍不能得到性质稳定的亚微乳,且单独以泊洛沙姆188为乳化剂的各处方制剂长期放置后平均粒径明显增大;聚乙二醇硬脂酸酯(HS15)与各油相结合制得的亚微乳均较稳定,长期放置后各项指标基本不变;聚山梨酯80与大豆油-中链油(1∶1)混合油或大豆油配伍制成的亚微乳在灭菌后产生较大粒径的乳滴,而与中链油相配伍可制得粒径较小且均匀分散的体系;蛋磷脂E80单独作为亚微乳乳化剂,乳化效果欠佳。结论大豆油、中链油及混合油与不同性质的乳化剂相互作用可共同影响亚微乳的粒径,但不同制剂的处方对亚微乳ζ电位无显著影响。
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