挤出滚圆法制备复方竹茶速释微丸  

The formulation and process of compound Zhucha pellet by extrusion-spheronization

作　　者：李丹[1] 初阳[2] 杨倩[3] 

机构地区：[1]沈阳医学院附属中心医院药剂科,辽宁沈阳110024 [2]中国医科大学附属第一医院药学部,辽宁沈阳110001 [3]沈阳药科大学药学院,辽宁沈阳110024

出　　处：《沈阳药科大学学报》2015年第3期182-187,233,共7页Journal of Shenyang Pharmaceutical University

基　　金：沈阳市科学技术计划项目(1091142-9-00)

摘　　要：目的采用挤出滚圆法制备复方竹茶速释微丸。方法以圆整度及收率为指标,单因素考察投药量、辅料种类、辅料配伍比例、润湿剂种类及用量、挤出速度、滚圆速度及滚圆时间,正交试验考察润湿剂用量、滚圆速度及滚圆时间,优选工艺并采用大鼠LDL-R的ELISA试剂盒为检测方法测定高脂大鼠肝脏组织液中LDL-R含量。结果按最优处方工艺分别称取质量分数为20%的药物投药量、微晶纤维素(microcrystalline cellulose,MCC)与乳糖[m(MCC)∶m(乳糖)=4∶1]作为骨架材料,以12 m L水做黏合剂制软材后,置入挤出滚圆造粒机,以40 Hz的挤出速度,50 Hz的滚圆速度滚圆5 min,制得微丸。微丸的平均圆整度为9.8°,收率为93.7%。复方竹茶胶囊能促进肝脏对于脂质的代谢功能,从而起到了调控血脂水平的作用。结论此工艺条件下制备的微丸能起到调控血脂水平的作用。Objective To study the formulation and process of compound Zhucha pellet by Extrusion-spheronization method. Methods Taking the sphericity and yield as the evaluation indexes. The factors such as drug content,the type of adhesive, the proportion compatibility of the adhesive on pellets＇ properties, the amount of wetting agent on pellets＇ properties, spheronization time,the speed of extrusion and spheronization which was influenced on the extraction were investigated. Based on the mono-factorial test, orthogonal test or uniform test was used to ootimizing the amount of wetting agent, soheronization soeed and soheronization time. And ELISA kits were used to determine LDL-R content in high lipid rat liver tissue. Results The optimal formulation was composed of 20% of dosing amount,MCC and lactose（m： m =4：1 ）respectively as the matrix materials. After being triturated with 12 mL of water, which acted as adhesive agent, the mixture was putted into extrusion-spheronization granulator to form the pellets. The speed of extrusion and spheronization were 40 Hz and 50 Hz respectively. The roundness of the pellets was 9.8° and the yield was 93.7%. The compound of Zhucha capsule can promote lipid metabolic function of rat liver, thus plays the important role of regulation and control of blood lipid levels. Conclusions The study shows that the prepared Zhucha capsules can be used to regulate and control blood lipid levels of rat.

关 键 词：挤出滚圆 竹叶黄酮 茶多酚 速释 微丸 

分 类 号：R966[医药卫生—药理学]