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目的:应用挤出滚圆法制备黄连效应组分微丸,研究中药微丸制备的新工艺。方法:在考察黄连效应组分物理性质的基础上,用新型的挤出滚圆造粒机制备黄连效应组分微丸,采用单因素试验优化制剂处方及工艺条件,评价了微丸的粉体学性质、收率和体外溶出度。结果:用挤出滚圆法制备的黄连效应组分微丸在15 min内体外溶出均达85%以上,且圆整度好,收率高。结论:用挤出滚圆法可制备中药微丸,该工艺简便易行,制得的微丸圆整度好,收率高,体外释药迅速。
OBJECTIVE: To prepare Pellets of Coptis Chinensis (Rhizoma Coptidis) by extrusion-spheronization and to study the new technology of preparation of Pellets of Traditional Chinese Medicine. Methods: Based on the investigation of the physical properties of Coptis chinensis, the new type of Pelleting effect pellets were prepared by a new extrusion spheronization granulator. The formulation and process conditions were optimized by single factor test, Nature, yield and in vitro dissolution. RESULTS: Pellets of Rhizoma Coptidis prepared by the extrusion-spheronization method all reached 85% or more in vitro dissolution within 15 min, with good roundness and high yield. Conclusion: The Chinese medicine pellets can be prepared by extrusion spheronization. The process is simple and easy. The prepared pellets have good roundness, high yield and rapid in vitro release.