复方丹参脉冲控释滴丸的制备及其体外释放度考察  

Study on Preparation and in Vitro Release Degree of Compound Danshen Pulsatile Controlled- Release Dropping Pellets

作　　者：李婷 陈连剑 李成 巫小娟 冯风明 

机构地区：[1]广东省深圳市福田人民医院,广东深圳518033

出　　处：《中国药业》2014年第6期43-45,共3页China Pharmaceuticals

摘　　要：目的制备复方丹参脉冲控释滴丸,并考察其体外释放度。方法以复方丹参滴丸为载药丸芯,对包衣材料配比及包衣材料用量进行选择,对控释滴丸体外释药情况进行考察。结果溶胀层的种类与包衣增重、控释层的包衣增重对药物的释放影响显著,采用交联羧甲基纤维素钠(CMC-Na)作为溶胀层材料,乙基纤维素水分散体作为控释层材料,溶胀层包衣增重12%,控释层包衣增重20%,所制备的微丸时滞时间为4 h左右,时滞后3 h内累积释药达到80%。结论制备的复方丹参脉冲控释滴丸体外释放可达到脉冲控释效果。Objective To prepare Compound Danshen Pulsatile Controlled- Release Dropping Pellets（CD- PCRDP） and to investigate its in vitro release degree. Methods Compound Danshen Dropping Pellets （CDDP） were taken as the drug-loaded core pellets,then the ratio and amounts of the coating materials were selected and the in vitro drug release of the controlled- release dropping pellets was investigated. Results The kinds and the coating weight gain of the swelling layer amt the coating weight gain of the controlled release layer had significant influence on the drug release. Croscarmellose sodium （CMC-Na） was adopted as the swelling layer material and ethylcellulose aqueous dispersion （surelease） as the controlled release layer material. The coating weight of the swelling layer was in- creased by 12% and which of the controlled release layer was increased by 20%. The lag time of prepared pellets was about 4 h,the accumulated drug release within 3 h after lag time reached to 80%. Conclusion The in vitro release of prepared CD- PCRDP can achieve the pulsatile controlled release effect.

关 键 词：复方丹参 脉冲控释滴丸 交联羧甲基纤维素钠 乙基纤维素水分散体 

分 类 号：TQ461[化学工程—制药化工] R283.6[医药卫生—中药学]