新型有效组份制剂红鹤胶囊多指标成分体外溶出特征研究  

Study on External Release Rate of Multiple Effective Components in Honghe Capsules

作　　者：王晴[1] 王英姿[1] 李友林[2] 倪健[1] 骆声秀 李凤英[1] 张春泥[1] 李文华[1] 张秀婷[1] 

机构地区：[1]北京中医药大学,北京100102 [2]中日友好医院,北京100029

出　　处：《辽宁中医药大学学报》2016年第8期56-59,共4页Journal of Liaoning University of Traditional Chinese Medicine

基　　金：国家科技重大专项课题(2012ZX09103201-044);北京中医药大学在读研究生项目(2015-JYB-XS076)

摘　　要：目的:建立新型有效组份制剂红鹤胶囊多指标成分体外溶出度的测定方法并评价其溶出度。方法:依据2010年版《中华人民共和国药典》,以900 m L的0.3%十二烷基硫酸钠溶液为溶出介质,采用桨法测定,转速为100 r/min,温度为(37±0.5)℃。实验以竹节参皂苷Ⅳa、总皂苷、总黄酮为检测指标,分别采用高效液相法和紫外分光光度法检测红鹤胶囊中竹节参皂苷Ⅳa、总皂苷和总黄酮的溶出含量。结果:红鹤胶囊的三批样品,在溶出时间为45 min时,竹节参皂苷Ⅳa的累积溶出率分别为91.29%、88.64%、91.72%;总皂苷的累积溶出率分别为89.41%、87.68%、87.10%;总黄酮的累积溶出率分别为91.02%、90.77%、89.98%。结论:经过溶出条件的系统筛选后所建立的溶出度测定方法稳定,结果可靠。红鹤胶囊中各指标性成分溶出度均符合药典规定。Objective：The experiment established a detection method for dissolution rate in vitro of multiple effective components in Honghe Capsules,and estimated it＇s quality. Methods：According to the 2010 edition of the＂Chinese Pharmacopoeia＂,900 m L 0.3% sodium dodecyl sulfate solution was used as dissolution media. The experiment used paddle method in condition of speed of 100 r/min and temperature of（37±0.5）℃. With chikusetsu saponin Ⅳa,total saponins and the flavonoids in Honghe Capsules as detection index,the HPLC was used to determined chikusetsu saponinⅣa,and total saponins and the flavonoids were determined by UV. Results：At 45 min,the cumulative dissolution rates of chikusetsu saponinⅣa were 91.29%,88.64%,91.72%;the cumulative dissolution rates of total saponins were 89.41%,87.68%,87.10%;the cumulative dissolution rates of flavonoids were 91.02%,90.77%,89.98% in three batches of Honghe Capsules. Conclusion：The dissolution method established by screening of dissolving condition was stable and reliable. The dissolution rate of all the major ingredients in Honghe Capsules conformed to the requirement of pharmacopoeia.

关 键 词：溶出度 竹节参皂苷Ⅳa 总黄酮 总皂苷 

分 类 号：R284.2[医药卫生—中药学]