注射用冻干雪莲的制备工艺及质量研究

Study on the Preparation Technique and Quality of Xuelian Freeze-dry Sterile Injection powder

目的:制备注射用冻干雪莲并建立其质量控制方法。方法:筛选赋形剂的种类和用量,得出最佳处方和制备工艺;以紫外-可见分光光度法测定其含量,并以含量、指纹图谱为主要指标考察其质量。另通过长期试验考察其稳定性。结果:使用40 %甘露醇作为赋形剂效果较好;含量测定中平均加样回收率为99. 4% (RSD=0. 90 % ) ;注射用冻干雪莲比注射液可更好地反应提取液的指纹图谱特征;且经室温留样12mo质量稳定。结论:处方合理、制备工艺可行、质量可控。

OBJECTIVE:To prepare xuelian freeze-dry sterile injection powder and to establish a quality control for this drug.METHODS:The best formulation and preparation technique of the powder for injection was optimized by screening the variety and quantity of vehicle;the contents,which were determined by UV,together with the finger print were taken as the main index to study the quality.The stability was observed through long test.RESULTS:Take the40%mannitol as excipient;The mean recovery results was99.4%(RSD=0.90%);The freeze-dry sterile injection powder could be reflection the finger print character of extract fluid better than injection.The preparation was stable after12months storage at room tempera-ture.CONCLUSION:The formulation is reasonable,the preparation technique is feasible and the quality is controllable.