大川芎脉冲片的制备工艺及体外释药特性研究  

Researches on Preparation and in Vitro Release of Pulsed-release Tablets of Da Chuan Xiong

作　　者：郑琴[1] 周欢[1] 钱佳[1] 胡双[1] 熊文海[1] 薛鑫[1] 王芳[1] 杨佳柳[1] 

机构地区：[1]江西中医学院现代中药制剂教育部重点实验室,南昌330004

出　　处：《江西中医学院学报》2013年第2期48-52,共5页Journal of Jiangxi College of Traditional Chinese Medicine

基　　金：十一五重大新药创制项目(项目编号:2009ZX09310-005);江西省卫生厅中医药科研计划(项目编号:2010A091);江西省自然科学基金(项目编号:20114BAB215042);江西省教育厅青年基金项目(项目编号:GJJ12533)

摘　　要：目的:以大川芎方为模型,研究片剂在成型及包衣过程中各因素对脉冲片释放度的影响,从而确定大川芎脉冲片的制备工艺,并考察其体外释药特性。方法:考察处方中不同辅料种类及配比、素片压片压力、包衣液浓度、包衣溶剂浓度、包衣增重比及致孔剂含量等处方因素对体外释放度的影响,以紫外分光光度法检测主要成分天麻素及阿魏酸含量。结果:处方中以25%CCMC-Na为崩解剂,乳糖11%,MCC 20%,以水为润湿剂,压片压力在7-9kg,溶胀层为1%HPMC溶于60%的乙醇,HPMC与EC-PEG 6000包衣增重比为4:3,EC:PEG 6000为5:1时,能使药物在5-6h时滞时间以内累积释放量小于10%,5-6h后出现突释,累积释放度达到80%以上。结论:采用优化的处方及包衣工艺能制备得到符合脉冲释药要求的大川芎包衣片。Objective： Da Chuan Xiong was employed as a model, main influence factors to release rate of the pulsed-release tablets were researched and evaluated by the release characteristics. Method： The composition and hardness of core tablets,types of coating solvents, concentration of coating liquid, ratio of coating weight ,content of pore-forming agent were investigated. The main ingredients, Gastrodine and Ferulic acid, were detected by UV spectrophotometry （UV）. Result： The optimized prescriptions were 25% CCMC-Na as disintegrating agent, 11% lactose and 20% MCC as filler, water as wetting agent, tablet pressure in 7-9 kg. The coating prescriptions were swelling layer containing 1% HPMC soluble in 60% ethanol, controlled-release with EC and PEG 6000 （5：1） ,ratio of coating weight HPMC：EC-PEG 6000 4：3. The cumulative release of this pulse release system was less than 10% within 5-6 h and above 80% with a sudden release after 5-6 h. Conclusion： Processing as above conditions and prescriptions, a pulse release system of Da Chuan Xiong would be obtained.

关 键 词：大川芎方 脉冲片 包衣工艺 体外释放 

分 类 号：R283[医药卫生—中药学]