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目的采用中心复合设计实验优化超临界CO2法制备盐酸小檗碱脂质体的处方工艺。方法考察药脂质量比和磷脂质量浓度对盐酸小檗碱脂质体包封率的影响,采用中心复合设计实验对超临界制备盐酸小檗碱处方工艺进行优化,并利用响应曲面法进行优化分析。结果最优的工艺条件为:药脂质量比为13.2∶60,磷脂质量浓度为30 g.L-1,理论包封率为73.30%,载药量为15.98%。在此条件下的实际包封率为(72.15±1.9)%,载药量为15.74%,接近理论预测值。结论作者研究的超临界CO2法制备盐酸小檗碱脂质体,实现了包封率与载药量的最佳组合,且工艺简单,适合工业生产。
OBJECTIVE To optimize the formulation of berberine hydrochloride liposomes by supercritical CO2 in a central composite design experiment. Methods The effects of the mass ratio of lipid to lipid and the concentration of phospholipids on the encapsulation efficiency of berberine hydrochloride liposomes were investigated. The center composite design experiment was used to optimize the formulation of berberine hydrochloride and the response surface methodology . Results The optimum conditions were as follows: lipid mass ratio of 13.2:60, phospholipid concentration of 30 g.L-1, theoretical entrapment efficiency of 73.30% and drug loading of 15.98%. Under these conditions, the actual entrapment efficiency was (72.15 ± 1.9)% and drug loading was 15.74%, close to the theoretical predictive value. Conclusion The author studied the supercritical CO2 preparation of berberine hydrochloride liposomes, encapsulation efficiency and drug loading to achieve the best combination, and the process is simple, suitable for industrial production.