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目的:制备脱水穿心莲内酯自乳化制剂,并对其质量进行评价。方法:通过溶解度试验初步筛选处方辅料种类,以乳化效果、乳化平衡时间、乳剂粒径大小及分布为指标,采用正交试验确定辅料,并结合三元相图确定最佳处方,考察该制剂稀释后形成乳液的外观、粒径、Zeta电位及制剂稳定性。结果:脱水穿心莲内酯自乳化最佳处方为m聚山梨酯-80∶m中链甘油三酯∶m甘油=50∶20∶30,粒径23.7 nm,Zeta电位-14.47 mV,自乳化速度快,室温放置3个月后稳定性良好。结论:优选的制备工艺简单、乳化时间快、粒径小,制备的自乳化制剂澄清透明、质量稳定。
Objective: To prepare dehydroandrographolide self-emulsifying preparation and to evaluate its quality. Methods: The types of prescription and auxiliary materials were preliminarily selected by the solubility test. The emulsifying effect, the equilibration time, the size and distribution of the emulsion were taken as the indexes. The orthogonal experiment was used to determine the excipients and the best prescription was determined by the ternary phase diagram. The appearance, particle size, zeta potential and formulation stability of the resulting emulsion. Results: The optimal self-emulsification of dehydroandrographolide was m polysorbate-80: m medium chain triglyceride: glycerol = 50:20:30, particle size 23.7 nm, zeta potential -14.47 mV, self-emulsification speed After 3 months at room temperature, the stability is good. Conclusion: The preparation process is simple, the emulsification time is fast, the particle size is small, the prepared self-emulsifying preparation is clear and transparent with stable quality.