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目的制备十一酸睾酮(TU)自微乳化制剂。方法通过伪三元相图绘制和自乳化效率的评价筛选TU自微乳化制剂处方,用HPLC测定药物的含量,考察制剂经高温和光照的影响因素试验后的质量。结果以辛癸酸甘油酯为油相、Cremophor EL/Tween 85(1:4)为混合乳化剂、油相与乳化剂重量比1:1作为TU自乳化制剂介质的处方,在不同介质能迅速形成自微乳液。经高温10d放置,TU自乳化制剂的质量未发生变化,光照10d后药物含量略有下降。结论制备了不含助乳化剂的TU自微乳化制剂,适合于进一步制成软胶囊。
Objective To prepare testosterone undecanoate (TU) self-microemulsifying preparation. Methods The formulation of TU self-microemulsifying preparation was screened by the pseudo-ternary phase diagram and the evaluation of self-emulsifying efficiency. The content of drug was determined by HPLC and the quality of the preparation after high temperature and light exposure was tested. The results showed that Cremophor EL / Tween 85 (1: 4) was a kind of emulsifier and the weight ratio of oil phase and emulsifier was 1: 1 as the formulation of TU self-emulsifying agent. Form a self-microemulsion. After 10d at high temperature, the quality of TU self-emulsifying formulation did not change, and the content of drug decreased slightly after 10 days of light irradiation. Conclusion TU self-microemulsifying formulations without emulsifier are suitable for further preparation of soft capsules.