盐酸小檗碱脂质体的制备方法及质量研究

Study on preparation of berberine hydrochloride liposome

目的 :制备盐酸小檗碱脂质体 ,并进行质量研究。方法 :通过测定包封率 ,优选盐酸小檗碱脂质体制备工艺 ,观测脂质体粒径和形态特征 ,同时考察其稳定性。结果 :盐酸小檗碱和聚山梨酯 80比例为 1∶0 .4、药脂比为 1∶2 0 ,所得脂质体呈球形或椭圆形 ,粒径范围为 2 .4～ 4 .6 μm ,包封率为39.77% ,RSD为 2 .16 % (n =3)。室温放置 2月 ,脂质体形态特征无明显变化。结论 :本方法制备盐酸小檗碱脂质体稳定可靠。

OBJECTIVE To prepare berberine hydrochloride lip osome (BHL) and evaluate the quality of the liposome. METHODS The preparation technology of BHL was optimized by det ermination of encapsulation efficiency of berberine hydrochloride. The character and stability of BHL were observed. RESULTS The weight proportions of brberine hydrochloride to pol ysorbate 80 and lecithin were 1∶ 0.4 and 1∶20 respectively.The liposome sh ape was spherical or ellipsoidal, and their size range was 2.4～ 4.6 μm .The encapsulation ratio of berberine hydrochloride in liposome was 39.77%( n=3,RSD= 2.16%).The characters had no significant changes compared with that stored for 2 months. CONCLUSION The preparation method is reliable.