注射用盐酸吉西他滨处方工艺研究

Technical study on the prescription of Gemcitabine Hydrochloride for Injection

目的设计一种稳定的注射用盐酸吉西他滨处方工艺。方法研究吉西他滨的物理性质,包括其配制溶液温度、pH值,并以冻干制品稳定性作为指标,通过正交设计筛选出了合适的甘露醇、醋酸钠用量。结果最佳处方工艺:主药1,醋酸钠0.06,甘露醇1,溶液pH值3.0,冻干时间约30 h左右。结论此注射用盐酸吉西他滨冻干工艺适用于工业化生产。

Objective To design a stable prescription of Gemcitabine Hydrochloride for Injection. Methods To investigate the physical properties of gemcitabine,including the temperature of solution, pH value and the proper dosage of mannitol and sodium acetate was selected according to experimental design using orthogonal table with the stability of product as index. Results The best extracting technology conditions were as follows ： the main drug 1, sodium acetate 0.06, mannitol 1, pH 3.0, freeze - dried for about 30 hours. Conclusion The prescription of Gemcitabine Hydrochloride for Injection was reasonable.