核黄素磷酸钠粉针处方及制备工艺研究

A Study on the Formulation and Preparation Technology of Riboflavin Sodium Phosphate Injectable Powder

目的通过试验确定核黄素磷酸钠粉针剂的处方和制备工艺。方法通过对冻干品的外观、含量、含水量、复溶性和溶解后澄明度等指标的考察确定最佳的支撑剂种类和用量、药液处理方法和冻干工艺参数。结果冻干前处方组成为核黄素磷酸钠13.69 g、焦亚硫酸钠2.0 g、EDTA-2Na 1.0 g、溶解于2000 ml蒸馏水中,室温下加0.10%(W/V)针用活性炭搅拌30 min除热原,0.22μm微孔滤膜滤过除菌,分装1000瓶,然后经-70℃预冻5 h,冻干机隔板-35℃预冻3 h,-15℃真空干燥12 h,15℃再干燥4 h即得。结论核黄素磷酸钠粉针处方合理,制备工艺可行。

Objective To determine the formulation and preparation technology of Riboflavin Sodium Phosphate injectable powder by experiments.Methods The appearance,drug content,water content,solubility and clarity of the freeze-died substace after dissolution were investigated to determine the kind and amount of support agents used,pre-processing methods of drug solution before freezing and the parameters of the freeze-drying process.Results The pre-freezing formulation consisted of riboflavin sodium phosphate 13.69 g,sodium pyrosulfite 2.0 g,EDTA-2Na 1.0 g,all of which were dissolved with 2000 ml of distilled water.0.10%（W/V）absorbite（injection grade）was added into the solution and agitated for 30 min at room temperature to remove the pyrogen.The solution was filtered with the 0.22 μm micropore film to remove the bacteria,subpackaged to 1000 bottles,and left frozen at-70℃ for 5h in a refrigerator,frozen at-35℃ for 3h in a freeze dryer,vacuum drying at-15℃ for 12h and drying again at 15℃ for 4h,before the freeze drying powder was finally obtained.Conclusion The formulation of Riboflavin Sodium Phosphate injectable powder we got seems acceptable and the preparation technology is feasible.