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100nm,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 hydrochloric acid 5-aminolevulinic acid(5-ALA) liposomes. Methods The 5-ALA lipsomes were produced by using film-pH gradient method evaluated by the encapsulation efficiency which was determined by HPLC. The prescription of 5-ALA was optimized by the orthogonal design. The physical and chemical properties as the particle size and electronic potential were studied. Results The optimum preparation technics were obtained as follows; the ratio of lecithin to cholesterol was 6:1, lecithin to 5-ALA was 6:1,which were incubated at 60 ℃. The liposomes produced was milk white, with an average particle size of 100 nm, Zela potential as -40 mV.and the average encapsulation efficiency was 65. 0%. Conclusion The formulation of 5-ALA liposomes is reasonable, the technology is practicable and efficient.
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