中药降脂微丸制备工艺研究及稳定性考察

Study on Preparation Technology and Stability of Traditional Chinese Medicine Jiangzhi Pellets

目的对中药降脂煎剂进行剂型改造,研究中药降脂微丸的制备工艺并考察其稳定性。方法采用HPLC测量指标成分;采用挤出滚圆法制备中药降脂微丸;采用单因素考察微丸的处方因素和工艺因素;利用Box-Benhnken设计筛选最优方案;利用经典恒温法考察稳定性。结果成功得到指标成分的标准曲线;所制得的微丸大小均匀,载药量大,圆整度好;最优的微丸制备工艺简单易操作;微丸的质量稳定。结论利用挤出滚圆法制备中药降脂微丸工艺简单易操作,质量稳定,利于工业化。

Objective To modify the dosage form of Jiangzhi decoction,study the preparation technology and stability of Jiangzhi pellets.Methods HPLC was used to measure index components.Chinese traditional medicine lipid-lowering pellets were prepared by extrusion spherification.Single factor was used to investigate the formulation and technological factors of pellets.Box-benhnken was used to design the optimal scheme.Stability was investigated by classical constant temperature method.Results the standard curve of index component was obtained successfully.The prepared pellets are uniform in size,large in charge and good in roundness.The optimal pellet preparation process is simple and easy to operate.The quality of pellets is stable.Conclusion The process of preparing Chinese traditional medicine Jiangzhi pellets by extrusion rolling method is simple,easy to operate,stable in quality and beneficial to industrialization.