不锈钢搅拌桶制剂验证研究

Study on validation of steeliness blender for preparation

目的 :证明不锈钢搅拌桶配制呋喃西林溶液的准确度及均匀性 ,并确定呋喃西林溶液的配制工艺条件。 方法 :测定桶内液面和桶底呋喃西林溶液的含量 ,以相对偏差大小验证溶液的均匀性 ;用相同的工艺条件配制 3批呋喃西林溶液 ,以样品含量对标准含量的相对误差大小验证配制方法的准确性。结果 :选取设备的最大容许配制量 ,配制数批呋喃西林溶液 ,搅拌10 min,桶内液面和桶底呋喃西林溶液含量相对偏差为 0 .2 3 47% ,与标准含量的相对误差均小于 1%。结论 :用本套不锈钢搅拌桶配制的呋喃西林溶液含量准确、均匀。因此 ,可将其正式用于配制呋喃西林溶液 ,满足临床所需。

Objective:To validate the homogenization and accuracy of furacilin solution prepared with steeliness blender,and to optimize the preparation technology of the furacilin solution. Methods: The concentrations of the furacilin solution at the bottom and top in the steeliness blender were determined, the relative deviation of concentrations of the furacilin solution was used to validate the homogenization; the relative deviation of concentration of the prepared furacilin solution to the standard concentration was used to validate the accuracy. Results: The relative deviation of concentrations of the furacilin solution at the bottom and top in the steeliness blender was 0.234 7%; the relative deviation of concentration of the prepared furacilin solution to the standard concentration was less than 1%. Conclusion: The furacilin solution prepared with steeliness blender is homogenization and accuracy, thus the steeliness blender is approved to be suited for preparing the furacilin solution in clinic.