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目的:优选穿心莲内酯自微乳化制剂的处方工艺,并对其质量进行评价。方法:通过溶解度试验、处方配伍对比试验及绘制三元相图优选处方辅料种类和用量范围,以形成乳液的形态、粒径、自乳化时间、制剂稳定性及zeta电位为指标,采用星点设计-效应面优化法优化自微乳化处方,并评价其质量。结果:穿心莲内酯自微乳化最佳处方为m聚山梨酯-80∶m油酸乙酯∶m甘油=50∶26∶26,乳滴粒径39.5 nm,Zeta电位-15.18 mV,自乳化时间40.53 s。结论:所制备的穿心莲内酯自微乳化制剂澄清透明,物理稳定性良好。
OBJECTIVE: To optimize the formulation of andrographolide self-microemulsifying preparation and to evaluate its quality. Methods: By means of the solubility test, the contrast test of the prescription and compatibility, the types and dosage ranges of the prescription prescriptions and the dosage range of the three phase diagram, the shape, the particle size, the self-emulsifying time, the preparation stability and the zeta potential of the emulsion were taken as the indexes. Optimization of self - microemulsifying prescription by effect surface optimization and evaluation of its quality. RESULTS: The best formulation of andrographolide self-microemulsification was m-polysorbate-80:m ethyl oleate: m glycerol = 50:26:26, the diameter of droplets was 39.5 nm, the zeta potential was -15.18 mV, the self-emulsification time 40.53 s. Conclusion: The prepared andrographolide self-microemulsifying formulation is clear and transparent with good physical stability.