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目的制备盐酸小檗碱微丸,尝试通过制备新剂型提高药物的生物利用度。方法采用挤出滚圆法制备盐酸小檗碱微丸,通过对挤出速率、润湿剂用量、滚圆转速等主要影响因素进行考察,优化微丸的制备工艺。结果采用润湿剂1%CMC-Na90ml,挤出速率40r/min,滚圆转速800r/min,滚圆时间2.5min制备微丸。制得的微丸球粒圆整度高,粒度均匀,表面光滑,结构紧密,具有一定的硬度,粒径范围0.47～0.78mm,平均粒径(0.64±0.08)mm。结论挤出滚圆法制备盐酸小檗碱微丸简便可行、重复性良好、质量可控。
Objective To prepare berberine hydrochloride pellets and try to improve the bioavailability of the drug by preparing new dosage forms. Methods The berberine hydrochloride pellets were prepared by extrusion spheronization. The main influencing factors such as extrusion rate, dosage of wetting agent and spheronization speed were investigated to optimize the preparation process of pellets. Results The wetting agent CMC-Na 1% 90ml, extrusion rate 40r / min, rolling speed 800r / min, spheronization time 2.5min pellets. The prepared pellet pellets have high roundness, uniform particle size, smooth surface, compact structure and certain hardness, with the particle size ranging from 0.47 to 0.78 mm and the average particle size (0.64 ± 0.08) mm. Conclusion The preparation of berberine hydrochloride pellets by extrusion spheronization is simple, feasible and reproducible, and the quality is controllable.