更昔洛韦阴道栓的制备及质量控制

目的:制备更昔洛韦阴道栓并建立其质量控制方法。方法:以明胶等为基质、更昔洛韦为主药制备栓剂;采用高效液相色谱法测定更昔洛韦的含量。结果:所制栓剂类白色透明鸭嘴形栓剂,软硬度合适;鉴别、检查等符合《中国药典》2005年版相应规定;更昔洛韦检测浓度线性范围为2.0～90.0 μg.mL~(-1)(r=0.999 9),平均回收率为99.28%(RSD=0.58%,n=9)。结论:更昔洛韦阴道栓制备工艺简单,含量测定方法操作简便、结果准确。

Preparation and Quality Control of Ganciclovir Vagina Suppository

OBJECTIVE：To prepare Ganciclovir vagina suppository and to establish the quality control standard of it.METHODS：Suppository was prepared with gelatin as base material and ganciclovir as main ingredients.The content of ganciclovir was determined by HPLC.RESULTS：The preparation was whitish transparent duck-bill suppository with proper hardness.The identification and test of suppository was in line with the standards stated in Chinese Pharmacopeia（2005 edition）.The linear range of ganciclovir was 2.0～90.0μg.mL^-1（r=0.999 9）The average recovery was 99.28%（RSD=0.58%,n=9）CONCUlSION：The preparation of Ganciclovir vagina suppository is easy in technological process.The content determination method is simple and accurate.