丹酚酸B渗透泵控释片的制备  

Preparation of osmotic pump controlled release tablet of salvianolic acid B

作　　者：刘睿[1] 刘志东[1] 高国义[1] 

机构地区：[1]天津中医药大学中医药研究院,现代中药发现与制剂技术教育部工程研究中心,中意中医药联合实验室,方剂学教育部重点实验室,天津300193

出　　处：《中国新药杂志》2010年第2期142-146,共5页Chinese Journal of New Drugs

基　　金：国际科技合作项目(2007DFC31670);国家重点基础研究发展计划(973计划)项目(2005CB523404);国家科技支撑计划项目(2007BAI47B01)

摘　　要：目的:研究丹酚酸B渗透泵控释片的处方及工艺,并对影响累积释放度的各种因素进行考察。方法:以体外累积释放度作为评价指标,采用单因素考察确定最优处方。结果:促渗剂的种类及剂量、聚乙二醇的种类及剂量、包衣增重对累积释放度有显著影响,片芯硬度、释药孔径、释放介质及转速对累积释放度无显著影响。结论:丹酚酸B渗透泵控释片在12 h内呈现良好的零级释放(r=0.993 1),药物累积释放比较完全(>92%)。Objective：To study the formulation and technology of salvianolic acid B osmotic pump controlled release tablets and investigate the influencing factors on drug release. Methods：The cumulative percent release was used as the evaluation standard for the drug release profile in vitro. Single factor tests were carried out on the formulation to determine the optimal formulation. Results ：The type and amount of osmotic promoting agents,the type and the amount of PEG, the weight of coating showed influence on the drug release behavior, while the hardness of tablet core, the diameter of orifice, the in vitro release condition had no significant effects. Conclusion ： More than 92% of salvianolie acid B was released from the salvianolic acid B osmotic pump controlled release tablets in twelve hours in vitro （ r = 0. 993 1 ） , following zero-order eharaetors.

关 键 词：丹酚酸B 渗透泵 控释片 

分 类 号：R286.2[医药卫生—中药学] R943.41[医药卫生—中医学]