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目的:制备醋酸地塞米松(dexamethasone acetate,DA)固体脂质纳米粒(solid lipid nanoparticles,SLN)并优化其处方组成。方法:采用乳化蒸发法制备醋酸地塞米松固体脂质纳米粒(DA-SLN)。以包封率、载药量及粒径为考察指标,运用正交试验设计优化处方。结果:DA-SLN的最优处方组成为A2B2C2D2,即药脂比1∶10,泊洛沙姆质量分数为2.0%,乳化温度为70℃,乳剂与分散相体积比为1∶6。优化处方的各指标值依次为粒径(180.8±3.3)nm,载药量(3.21±0.01)%,包封率(78.7±0.5)%。结论:乳化蒸发法适于制备DA-SLN,经优选后得到的处方合理、可行,可用于DA新型局部给药制剂的研究。
Objective: To prepare solid lipid nanoparticles (SLN) of dexamethasone acetate (DA) and optimize the formulation of dexamethasone acetate (DA). Methods: Dexamethasone acetate solid lipid nanoparticles (DA-SLN) were prepared by emulsion evaporation. Taking the entrapment efficiency, drug loading and particle size as indexes, orthogonal design was used to optimize the prescription. Results: The optimum prescription of DA-SLN was A2B2C2D2, namely, the ratio of lipid to lipid was 1:10, the content of poloxamer was 2.0%, the temperature of emulsification was 70 ℃ and the volume ratio of emulsion to dispersed phase was 1: 6. The indexes of optimized prescription were 180.8 ± 3.3 nm in diameter, 3.21 ± 0.01% in drug load, and the entrapment efficiency was 78.7 ± 0.5%. Conclusion: The emulsification evaporation method is suitable for the preparation of DA-SLN. The prescription obtained after the optimization is reasonable and feasible, and can be used for the study of new topical DA formulations.