硫酸奈替米星葡萄糖注射液的生产工艺研究

目的　探讨硫酸奈替米星葡萄糖注射液的制备工艺,确定生产工艺参数和最佳生产工艺路线,为氨基糖苷类抗生素药物生产提供依据。方法　采用正交试验的方法优化生产工艺,并用室温留样试验方法进行初步稳定性考察,选择最佳工艺参数。结果　确定该产品生产工艺为加入适量的稳定剂,10 5℃,30min灭菌。结论　用该方法制备的硫酸奈替米星葡萄糖注射液质量稳定,有效期为2年。该生产工艺设计合理,可作为产品生产工艺规程执行。

Study on the preparation of Netilmicin Sulfate Injection

Objective In order to obtain the optimum production technics and technical parameter,the preparation of Netilmicin Sulfate Injection was investigated.Methods The production technics of Netilmicin Sulfate Injection was optimized by orthogonal experiment and its stabilization was proved by remaining sample at room temperature.Results The optimum technical parameter was as following:adding stabilizer as required,sterilizing at 105℃ for 30 minutes.Conclusion The Netilmicin Sulfate Injection is stable and its validity period is 2 years.This technics is reasonable and can be perfromed as the technics discipline of produce.