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目的对十一酸睾酮微乳的处方和相图进行研究。方法选用肉豆蔻酸异丙酯(IPM)为油相,通过滴定法绘制伪三元相图,筛选并优化处方。结果确定了最终空白微乳处方为IPM:Cremophor EL:Labrasol:水=5:13:7:75(O/W型),十一酸睾酮最大载药量8·2mg/ml。结论所选择的微乳处方均可以满足十一酸睾酮用药的要求,为开发十一酸睾酮新的给药剂型拓展了思路。
Objective To study the prescription and phase diagram of testosterone undecanoate microemulsion. Methods IPM was selected as the oil phase. The pseudo-ternary phase diagram was drawn by titration and the prescription was optimized. The results showed that the final blank microemulsion formulation was IPM: Cremophor EL: Labrasol: water = 5:13:7:75 (O / W type), and the maximum drug loading of testosterone undecanoate was 8.2 mg / ml. Conclusion The selected microemulsion prescriptions can meet the requirement of testosterone undecanoate, which expands the train of thought for developing new dosage forms of testosterone undecanoate.