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目的:以红景天药材为原料,采用现代科学技术手段,制成冻干粉针剂。方法:以外观、成型性和复溶性为指标,优化冻干制剂处方和工艺,制备红景天冻干粉针剂。结果:以110mg/支甘露醇为赋形剂,-50℃预冻10h,抽真空,在-50℃时保温10h,最后升温至室温干燥,保持5h。制得的产品外形饱满、疏松,成型性好。结论:红景天冻干粉针剂的制备工艺稳定可行。
Objective: Rhodiola herbs as raw materials, the use of modern science and technology, made of lyophilized powder. Methods: The appearance, formability and rehydration as an indicator to optimize the preparation of lyophilized formulations and processes, preparation of Rhodiola freeze-dried powder. Results: 110mg / branch mannitol was used as excipient and pre-frozen at -50 ℃ for 10h, then evacuated and incubated at -50 ℃ for 10h. Finally, the solution was warmed to room temperature for 5h. The product shape is full, loose, good formability. Conclusion: Rhodiola freeze-dried preparation process is stable and feasible.