人纤维蛋白原装量差异试验的摸索

The Exploration of the Packing Amount Divergence Test of the Fibrin

目的由于人纤维蛋白原黏度较大,对于装量差异检查方法的精准度与实验时程有一定的影响。本实验旨在《中国药典》2015年版中装量差异检查方法的基础上进行试验摸索,提高日常检验工作的效率。方法利用氢氧化钠溶液作为该药品的清洗剂,对模制瓶进行清洗,实验设置0.1 mol/L、0.5 mol/L、1 mol/L、5 mol/L、10 mol/L、25 mol/L共6个浓度的氢氧化钠溶液作为清洗液对人纤维蛋白原进行清洗,后对比常规试验方法的试验时程、装量差异结果,得出结论。结果在氢氧化钠溶液浓度超过5 mol/L时,模制瓶瓶壁上无药品残留。后与常规方法相比较,对同一批药品来说,装量差异准确度提高。常规方法最大装量差异在0.03%,利用氢氧化钠清洗后的最大装量差异为0.3%,装量差异准确度提高了10倍。由于用于冲洗的时间由平均17 min减少至1.3 min,试验时程得到缩短。结论发现利用氢氧化钠作为清洗剂对人纤维蛋白原进行清洗时更加精确、省时。

Objective The original viscosity of fibrin is large.It affects the experimental accuracy and experimental time of the packing amount divergence.This research studies on the packing amount divergence to the"Chinese pharmacopoeia"2015 version.It has improved work efficiency in terms of inspection.Methods Sodium hydroxide solution as a cleaning agent belongs to fibrinogen.The molded bottle was cleaned using cleaning fluid.NaOH solutions with 6 concentration gradients of 0.1 mol/L,0.5 mol/L,1 mol/L,5 mol/L,10 mol/L and 25 mol/L were set.Then it was compared with the conventional test methods and the conclusion was drawn.Results When the concentration of NaOH solution exceeds 5 mol/L,the residue is not found on the molded bottle.It is compared with conventional methods.The accuracy of the experimental results was improved.The packing amount divergence of conventional method is 0.03%,and its packing amount divergence is 0.3%.The accuracy was increased 10 times.The average time was reduced from 17 min to 1.3 min in terms of flushing.The test time is shortened.Conclusion Fibrinogen is washed using NaOH as a cleaning agent.The results are more accurate and time-saving.