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目的研究盐酸5-氨基酮戊酸(5-ALA)脂质体处方组成及制备工艺。方法采用薄膜分散-pH梯度法制备5-ALA脂质体,以包封率为评价指标进行正交实验筛选出最佳处方,采用高效液相色谱(HPLC)法测定其包封率。并对其粒径、电位等理化性质进行研究。结果最佳处方工艺为:卵磷脂与胆固醇的质量比为6∶1,卵磷脂与5-ALA质量比为6∶1,孵育温度为60℃。所制脂质体为乳白色,平均粒径为100 nm,Zeta电位为-40 mV,平均包封率为65.0%。结论该制备方法得到的5-ALA脂质体处方合理,工艺可行,包封率较高。
Objective To study the formulation and preparation of 5-aminolevulinic acid (5-ALA) liposomes. Methods 5-ALA liposomes were prepared by thin-film dispersion-pH gradient method. The optimum formulation was screened by orthogonal test with the entrapment efficiency as evaluation index. The entrapment efficiency was determined by high performance liquid chromatography (HPLC). And its particle size, potential and other physical and chemical properties of the study. Results The optimal prescription was: the mass ratio of lecithin to cholesterol was 6:1, the mass ratio of lecithin to 5-ALA was 6:1, and the incubation temperature was 60 ℃. The prepared liposomes are milky white, the average particle size is 100 nm, the zeta potential is -40 mV, and the average entrapment efficiency is 65.0%. Conclusion The 5-ALA liposome obtained by the preparation method has reasonable prescription, feasible technology and high entrapment efficiency.