盐酸伐昔洛韦栓的制备及质量控制  

Preparation and Quality Control of Valaciclovir Hydrochloride Suppository

作　　者：孟宪丽[1] 李金伟[1] 杜习智[1] 何西奎[1] 

机构地区：[1]河南省人民医院药剂科,郑州市450003

出　　处：《中国药房》2007年第7期533-535,共3页China Pharmacy

摘　　要：目的:制备盐酸伐昔洛韦栓并建立其质量控制方法。方法:以明胶等为基质制备栓剂;采用高效液相色谱法测定盐酸伐昔洛韦的含量,并考察其稳定性。结果:所制栓剂软硬度合适;盐酸伐昔洛韦检测浓度线性范围为10.1～50.5μg·mL-1(r=0.9998),平均回收率为98.73%(RSD=0.76%,n=3)。结论:该处方制备工艺简单,制剂质量稳定、可控。OBJECTIVE： To prepare the valaciclovir hydrochloride suppository and to establish a quality control method. METHODS： The proper base material was gelatin. The valaciclovir hydrochloride was determined by HPLC and the stability test was performed. RESULTS： The prepared suppository had a proper hardness. There was a good linearity of calibration curve of valaciclovir hydrochloride in rang of 10.1-50.5μg·mL^-1（ r = 0. 999 8）. The average recovery was 98.73% （RSD= 0.76%, n = 3）.The suppository was stable. CONCLUSION： This method was simple, and the formulation thus prepared was stable and controllable in quality.

关 键 词：盐酸伐昔洛韦栓 制备 质量控制 

分 类 号：R927.2[医药卫生—药学] R944.23