中药复方抗乙肝病毒胶囊的开发与研制  

Research on the Preparation of Compound Herbal anti-HBV Capsule

作　　者：翟青[1] 许蓓[1] 卞晓岚[1] 苏静英[1] 

机构地区：[1]上海交通大学医学院附属瑞金医院,上海200025

出　　处：《中国药师》2007年第10期945-947,共3页China Pharmacist

基　　金：上海市科委科研基金项目(编号044119711)

摘　　要：目的:根据临床长期实践,用八角莲和叶下珠开发用于抗慢性乙肝病毒的中药复方医院制剂。方法:用经正交法得到的工艺制备胶囊制剂,参照中国药典(2005年版二部)进行制剂质量标准的研制和制剂稳定性的考察及临床疗效观察。结果:该复方制剂质量稳定;临床初步观察有一定的疗效,两组病人治疗前后症状明显改善可达95%以上,肝功能改善有效率98.1%(ALT)和96.5%(TBIL),与对照组相比均有显著性差异(P<0.01)。结论:上述方法制备的中药复方抗乙肝病毒胶囊质量较好。Objective： To develop a compound herbal medicine with clinical anti-HBV activity according to long clinical experiences. Method： The main method used in the study were prepared a compound herbed medicine with BAJAOLIAN and YEXIAZHU, its quality control method was established, its stability and the clinical effects were investigated, all the tests were carried out by ChP （2005） Vol II. Result： After treatment, symptoms got obviously better to 95%, the effective rates of the ALT and the TBIL were 98.1% and 96.5% ,there was significant difference compared to the control group. Conclusion： A compound herbal capsule with high clinical anti-HBV activity can be produced of good quality by the way described here.

关 键 词：复方抗病毒胶囊 质量标准 乙型肝炎 

分 类 号：R283.65[医药卫生—中药学]