辅料对改善强力宁提取液喷雾干燥粘壁现象的作用研究  

Improvement to wall sticking to Qianglining Extractum in spray drying by different excipients

作　　者：王优杰[1,2] 冯怡[1,2] 杨胤[1] 徐德生[3] 阮克锋[1,2] 谢亚林[1] 

机构地区：[1]上海中医药大学中药现代制剂技术教育部工程研究中心,上海201203 [2]上海张江中药现代制剂技术工程研究中心,上海201203 [3]上海中医药大学附属曙光医院,上海200021

出　　处：《中成药》2012年第1期34-38,共5页Chinese Traditional Patent Medicine

基　　金：上海市教委重点学科建设项目(J50302);国家科技部十一五重大新药创制(2009ZX09502-009);上海市公共研发服务平台(20103107110011)

摘　　要：目的研究不同辅料对解决中药复方强力宁提取液喷雾干燥粘壁的效果。方法对辅料的种类、用量,喷雾干燥的工艺进行优化,并通过对有效成分溶出度的考察初步评价其可能对药效的影响。结果强力宁提取液中添加占干膏量10%的轻质氧化镁,及3%微晶纤维素,在工艺为进风温度120℃,雾化压力1.05 bar,进液体积流量4.5 mL/min,进风风量35.0 m3/h的条件下进行喷雾干燥,可有效改善粘壁问题。且紫丁香苷溶出度实验显示,加入辅料不影响药物的溶出。结论 轻质氧化镁对改善强力宁提取液喷雾干燥粘壁非常有效,同时加入少量的微晶纤维素能够改善喷雾干燥粉末的团聚现象。AIM To improve wall sticking to Qianglining Extractum during spray drying by using different excipients.METHODS The kinds and dosage of the adjuvant were optimized.The technological parameters of the spray dryer were investigated.And the influences of drug effect were preliminary evaluated by dissolution test.RESULTS The best formula consisted of 10% light magnesia and 3% MCC.The optimal spray-drying parameters were composed of inlet air temperature of 120 ℃,inlet air flow of 35.0 m3/h,1.05 bar atomization pressure,and 4.5 mL/min pump speed.The results of syringin dissolution test showed that the main active substance dissolution was not affected by light magnesia and MCC.CONCLUSION Light magnesia is a vital role in improving the wall sticking of Qianglining Extractum.MCC could prevent the coacervation during spray drying.

关 键 词：轻质氧化镁 微晶纤维素 喷雾干燥 粘壁 强力宁提取物 

分 类 号：R944[医药卫生—药剂学]