丝裂霉素眼用冻干粉的研制及质量控制  

Preparation and Quality Control of Mitomycin Freeze-Dried Powder for Ocular Use

作　　者：马珂[1] 俞佳[2] 郑水莲[2] 俞振伟[1] 黄绳武[3] 

机构地区：[1]浙江大学医学院附属邵逸夫医院,杭州310016 [2]浙江省人民医院,杭州310014 [3]浙江中医药大学药学院,杭州310053

出　　处：《中国药学杂志》2011年第20期1587-1590,共4页Chinese Pharmaceutical Journal

摘　　要：目的制备丝裂霉素眼用冻干粉,并建立质量控制方法,为临床使用提供安全的药物。方法以氯化钠为辅料制备丝裂霉素眼用冻干粉,考察活性炭使用量、pH值、冻干时间等因素对制剂质量的影响;建立酸碱度、渗透压等检查的方法,使用HPLC测定含量和有关物质;进行稳定性研究。结果活性炭使用量为0.005%,pH值为6.5～8.0,冻干总时间为35 h时制剂的质量最佳;本品的渗透压为(307.3±2.1)mOsm.kg-1,pH值为6.94±0.03,干燥失重为(0.74±0.03)%,其余检查项均符合质量标准。丝裂霉素眼用冻干粉对光照和高温敏感,本品采用避光包装在加速实验下6个月和长期稳定性实验下12个月是稳定的。结论丝裂霉素眼用冻干粉制备简单,质量稳定;所建立的质量控制方法可靠,可用于本品的质量控制。OBJECTIVE To prepare mitomycin freeze-dried powder for ocular use and to establish its quality control method,thus to provide a safe drug for clinical use.METHODS The mitomycin powder was prepared using sodium chloride as the excipient.The influence of activated carbon amount,pH value and freeze-drying time on the powder quality was investigated.The contents of mitomycin and related substances were investigated by HPLC.The stability test was also performed.RESULTS The optimal preparation was obtained with 0.005% activated carbon,pH value of 6.5-8.0 and freeze-drying time of 35 h.The osmotic pressure of the final product was（307.3±2.1）mOsm·kg-1,pH value was 6.94±0.03,loss on drying was（0.74±0.03）%,and the other parameters were all in accordance with the quality standard.Mitomycin freeze-dried powder was sensitive to light and high temperature.It was stable for 6 months under accelerate condition and 12 months under long-term test condition in light resistant packages.CONCLUSION The preparation technique of mitomycin freeze-dried powder is simple.The formulation is stable,and the quality control method is accurate and reliable.

关 键 词：丝裂霉素 冻干 质量控制 翼状胬肉 说明书之外 

分 类 号：R944[医药卫生—药剂学]