硫酸奈替米星葡萄糖注射液的初步稳定性考察

Study on stabilization of netilmicin sulfate injection

目的:探讨影响硫酸奈替米星葡萄糖注射液稳定性的因素,为医院制剂生产提供指导。方法:采用正交设计试验方法考察影响其稳定性的因素,选择最佳工艺参数;采用高效液相色谱法测定含量。结果:生产中各因素影响硫酸奈替米星葡萄糖注射液稳定性的显著性,分别为灭菌温度>pH值>吸附剂种类,确定生产工艺中灭菌温度为105℃,pH为5.5,加入适当的稳定剂。结论:生产中应注意影响硫酸奈替米星葡萄糖注射液稳定性的因素,提高产品质量。

Objective： In order to provide some directions for hospital preparation, the stability of Netilmicin Sulfate Injection was investigated. Methods： The stabilization factors of Netilmicin Sulfate Injection was optimized by orthogonal experiment, the optimum production parameter was obtained; the content was determined by HPLC. Results： In the Preparation, the right factors influencing sulfate Netilmicin glucose injection stability significantly, sterilization temperature 〉 pH 〉 type of adsorbent. The production technics was as following： sterilizing at 105 ℃ for 30 minutes, pH of 5.5, adding stabilizer as required. Conclusion： In the Production,we should pay attention to the factors affecting sulfate Netilmicin glucose injection stability, improving the quality of products.