更昔洛韦眼用凝胶剂稳定性研究及有效期确定

Stability studies and validity period comfirmation of Ganciclovir Ophthalmic gel

目的对更昔洛韦眼用凝胶剂进行稳定性研究试验,确定有效期。方法参阅2010年版中国药典《原料药与药物制剂稳定性试验指导原则》对其进行影响因素试验、加速试验和长期试验,考察各项检测指标。结果更昔洛韦眼用凝胶剂在稳定性试验条件下外观性状、p H、含量等检测指标变化均不大,有关物质略有增高。结论本品在不同温度、湿度等贮存条件下质量稳定,符合药品质量标准的规定,有效期可定为1.5年。

OBJECTIVE To study the stability test of Ganciclovir Ophthalmic gel and confirm its validity peri-od.METHODS Referring to 《Raw material medicine and drug test guide preparation stability principle》 of Chi-nese Pharmacopoeia 2010 Edition,Experimentize the accelerated test,influencing factor test and long term test,inves-tigate all detection index.RESULTS The quality of Ganciclovir Ophthalmic gel is steady in the storage conditions of different temperature and humidity,in accordance with provisions of drag quality standard,to determine the effec-tive period for one and a half years.