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目的:本实验研制土荆芥油自微乳化制剂(MTH-SMEDDS),并对制剂进行质量评价。方法:以伪三元相图为指导考察药物与不同乳化剂、油相形成乳剂的能力和区域,绘制不同处方组成的相图,在此基础上优化处方,制备土荆芥油正、负电荷自微乳化制剂,并进行了自乳化时间、乳剂的形态、粒径分布、Zeta电位、含量、稳定性等质量评价。结果:最终选出MTH-SMEDDS最佳处方为:土荆芥油(40%),辛酸甘油三酯(10%),聚山梨酯-80(50%),苯甲酸(2%)。MTH-SMEDDS的平均粒径为30nm,自微乳化时间<1min。结论:该自微乳化给药制剂粒径较小呈正态分布,稳定性良好。
OBJECTIVE: To study the preparation of MTH-SMEDDS and to evaluate its quality. Methods: The pseudo-ternary phase diagram was used as the guide to investigate the ability and area of drug and emulsifier and oil phase to form emulsion. The phase diagrams of different prescriptions were drawn. On the basis of this, the prescription was optimized and the positive and negative charges Self-microemulsification preparation, and self-emulsifying time, the shape of the emulsion, particle size distribution, Zeta potential, content, stability and other quality evaluation. Results: The best prescriptions of MTH-SMEDDS were as follows: earthworm oil (40%), caprylic triglyceride (10%), polysorbate-80 (50%) and benzoic acid (2%). MTH-SMEDDS average particle size of 30nm, self-microemulsification time <1min. Conclusion: The particle size of the self-microemulsifying drug formulation is normally distributed with good stability.