摘要
目的 :制备盐酸洛美沙星中空栓剂并研究其稳定性。方法 :用热熔法制备中空栓剂并采用加速实验、强光照射实验、留样观察 3种方法对该制剂稳定性进行考察。结果 :制剂符合设计要求 ,按稳定性重点考察性状、融变时限、含量、有关物质检测等项目 ,均合格。结论 :本制剂工艺可行 ,质量稳定 ,可应用于临床。
OBJECTIVE To study the preparation of the hollow type suppository of lomefloxacin hydrochloride and its stability. METHODS The preparation of hollow type suppository was conducted by using the method of hot-melting, and the study on its stability by accelerated test, forced degradation test and long term stability test. RESULTS The preparation conformed with the requirement of design,it was qualified in the testing of characteristics,softening time,content, related substance. CONCLUSION The solid dispersion hemin is a solid solution. The solubility and dissolution of hemin in solid dispersion was increased. The preparation technic is feasible. This result provides scientific basis for research of new preparation of hemin.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2004年第3期136-138,共3页
Chinese Journal of Hospital Pharmacy
关键词
盐酸洛美沙星
中空栓剂
稳定性
hemin
solid dispersion
solubility
dissolution
dispersing character
