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目的:研究鸦胆子油自乳化制剂,探求其最佳处方配比,进行剂型改进。方法:通过溶解度实验、正交筛选和伪三元相图的绘制,以乳化程度、未乳化油的体积和所得乳滴粒径的大小为指标,对鸦胆子油处方中的药物、油相、表面活性剂的用量比例进行筛选,寻找出最佳的搭配和处方配比。结果:在鸦胆子油的自乳化制剂处方中,当油相选用中链脂肪酸三酰甘油、非离子表面活性剂选用吐温-85时,可以获得较好的乳化效果,粒径为0.1692μm,且乳化制剂的质量、稳定性与重现性良好。结论:鸦胆子油自乳化的最佳处方比例为鸦胆子油:中链脂肪酸三酰甘油:吐温-85=1:1:4。
Objective: To study the self-emulsifying preparation of Brucea javanica oil, explore the best prescription ratio and improve the dosage form. Methods: According to the degree of emulsification, the volume of non-emulsified oil and the size of the obtained emulsion droplets, the solubility, the orthogonal sieve and the pseudo-ternary phase diagram were used as indexes to determine the drug, oil phase, Surfactants were screened to determine the best combination and prescription ratio. Results: In the self-emulsifying preparation of Brucea javanica oil, when the medium-chain fatty acid triglyceride was chosen as the oil phase and Tween-85 as the nonionic surfactant, the better emulsification effect was obtained. The particle size was 0.1692μm, The quality, stability and reproducibility of the emulsified preparation are good. Conclusion: The optimal prescription of Brucea javanica oil self-emulsifying is Brucea javanica oil: medium chain fatty acid triglyceride: Tween-85 = 1: 1: 4.