摘要
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.
出处
《江苏大学学报(医学版)》
CAS
2009年第2期132-134,138,共4页
Journal of Jiangsu University:Medicine Edition