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目的研制多烯紫杉醇纳米乳并对其质量进行评价。方法先测定多烯紫杉醇在不同油相中的溶解度,再采用伪三元相图法研究不同乳化剂、助乳化剂和Km值形成纳米乳的能力和区域,绘制不同处方组成的相图,在此基础上制备多烯紫杉醇纳米乳;并对纳米乳的物理性质、稳定性进行研究。结果以辛癸酸甘油三酯/聚氧乙烯氢化蓖麻油/聚乙二醇400/水形成了均匀稳定,粒径呈正态分布的纳米乳系统;用不同的介质稀释后,多烯紫杉醇纳米乳的粒径变化差异不明显;初步稳定性实验表明,多烯紫杉醇纳米乳在强光和高温条件下放置10d,室温储存3个月,药物含量和粒径均没有显著变化,稳定性良好。结论多烯紫杉醇纳米乳制备简单,质量稳定,为开发多烯紫杉醇新型口服制剂提供了依据。
Objective To develop docetaxel nanoemulsion and evaluate its quality. Methods To determine the solubility of docetaxel in different oil phases, the ability and area of different emulsifiers, co-emulsifiers and Km values to form nanoemulsion were studied by pseudo-ternary phase diagram method. The phase diagrams of different prescriptions were drawn. On this basis, docetaxel nanoemulsion was prepared. The physical properties and stability of nanoemulsion were studied. Results The caproic acid triglyceride / polyoxyethylene hydrogenated castor oil / polyethylene glycol 400 / water formed a uniform and stable nanoemulsion system with normal distribution of particle size. After dilution with different media, docetaxel nano The results showed that there was no obvious change in the particle size of the emulsion. The preliminary stability experiments showed that the docetaxel nanoemulsion placed in the light and high temperature for 10 days, stored at room temperature for 3 months, the drug content and particle size did not change significantly, good stability. Conclusions Docetaxel nanoemulsion is simple and stable in quality, which provides the basis for the development of a new oral formulation of docetaxel.