硫酸奈替米星葡萄糖注射液的初步稳定性考察.doc

硫酸奈替米星葡萄糖注射液的初步稳定性考察
作者:戈延茹, 曹恒杰, 姜树红, 任宏
【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℃,,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。
【关键词】硫酸奈替米星葡萄糖注射液; 生产工艺; 稳定性; 正交设计
[Abstract] Objective: In order to provide some directions for hospital preparation,the stability ilmicin Sulfate Injection was investigated. Methods: The stabilization factors ilmicin 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 ilmicin glucose injection stability significantly, sterilization temperature > pH >type of adsorbent. The production technics was as following: sterilizing at 105 ℃ for 30 minutes, pH of , adding stabilizer as required. Conclusion: In the Production,we should pay attention
to the factors affecting ilmicin glucose injection stability, improving the quality of products.
[Key words] Netilmicin Sulfate Injection; production technics; stabilization; orthogonal design
硫酸奈替米星为一新的半合成的氨基糖苷类广谱抗生素,具有广泛的抗微生物作用,主要针对革兰阴性杆菌属和少数革兰阳性菌[1]。硫酸奈替米星注射液有较高的生物利用度,毒性小,耐受性好,临床疗效高,在防治细菌感染方面,具有较好的治疗作用。由于硫酸奈替米星易溶于水,对热、光不稳定,注射剂制备和贮存过程中易变色,而且异常毒性检查常常不合格,因此研究一条比较可控的制备工艺路线,确定最佳的工艺参数尤为重要。本试验采用正交实验,寻找影响其稳定性的有关因素。
1 仪器与试剂
1.