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目的研究以β-谷甾醇为膜稳定剂的囊泡的制备工艺,寻找制备囊泡的新材料。方法以盐酸小檗碱为模型药物,以β-谷甾醇为膜稳定剂,采用薄膜分散法制备囊泡。采用正交实验设计考察影响囊泡包封率的因素。建立HPLC法测定盐酸小檗碱含量,研究囊泡的包封率及稳定性。结果盐酸小檗碱囊泡的最优制备处方为:盐酸小檗碱的浓度为0.5mg·ml-1,司盘20与β-谷甾醇质量比为250∶15,缓冲液p H值为10。所得囊泡粒径在300~800 nm,包封率为36.9%。放置7d后,包封率达到最大值38.14%。结论以β-谷甾醇为膜稳定剂的盐酸小檗碱囊泡圆整度好,形态均一,包封率较高,但常温下放置稳定性不佳。
OBJECTIVE To study the preparation of vesicles with β-sitosterol as membrane stabilizer and to search for new materials for preparing vesicles. Methods Berberine hydrochloride was used as model drug and β-sitosterol was used as membrane stabilizer to prepare vesicles by membrane dispersion method. Orthogonal experimental design was used to investigate the factors affecting vesicle encapsulation efficiency. To establish a HPLC method for the determination of berberine hydrochloride and to study the entrapment efficiency and stability of the vesicles. Results The optimal formulation of berberine hydrochloride vesicles was as follows: the concentration of berberine hydrochloride was 0.5mg · ml-1, the mass ratio of Span 20 to β-sitosterol was 250:15, and the pH value of buffer was 10 . The size of the obtained vesicles was 300-800 nm, and the entrapment efficiency was 36.9%. After 7 days, the entrapment efficiency reached a maximum of 38.14%. Conclusion The roundness of berberine hydrochloride capsules with β-sitosterol as a film stabilizer is good, with uniform morphology and high entrapment efficiency, but the stability of vesicles is poor at room temperature.