不同检测方法在银杏叶缓释制剂处方设计中的比较研究  

Comparative study of different detection methods on prescription design of ginkgo biloba extract with sustained release preparation

作　　者：郭迎新[1] 潘卫三[1] 李非[1] 赵倩倩[1] 萧伟[2,3] 徐璐[1] 杨星钢[1,3] 

机构地区：[1]沈阳药科大学,110016 [2]江苏康缘药业股份有限公司,222001 [3]中药制药过程新技术国家重点实验室,222001

出　　处：《天津中医药大学学报》2013年第3期157-160,共4页Journal of Tianjin University of Traditional Chinese Medicine

基　　金：国家重点基础研究发展计划(973计划)项目(2012CB724001);中药制药过程新技术国家重点实验室开放基金项目(SKL2010Z0301)

摘　　要：[目的]比较采用紫外分光光度法和高效液相色谱法(HPLC法)测定银杏黄酮醇苷类成分含量的差异性,并为银杏叶缓释制剂处方设计建立一种简单、有效、可靠的方法。[方法]紫外分光光度法以总黄酮醇苷为指标成分,于266 nm处测定吸光值。采用HPLC法测量黄酮苷元(槲皮素、山奈素、异鼠李素)3种指标成分,用FDA推荐的f2相似因子法来评价两种检测方法的相似性。[结果]两种检测方法的方法学验证均符合要求,且f2因子值均大于50,两者相似性良好。[结论]在银杏叶缓释制剂处方设计过程中,可以采用紫外分光光度法代替HPLC法来测定黄酮醇苷类成分的含量。该法操作省时、简便、准确、可靠。[Objective] To investigate the quantitative determination of flavonol glycosides in ginkgo biloba extract using UV spectrophotometry and HPLC,then establish a simple,effective and reliable method for the prescription design of ginkgo biloba extract of sustained release preparation.[Methods] The total flavonoid glycosides were used as the reference compound for UV spectrophotometry.The Quercetin,Kaempferide and Isorhamnetin were used as the reference compound for HPLC.The similarity between UV and HPLC was estimated by the similarity factor method,which was recommended by FDA.[Results] The methodological evaluation showed that those two detection methods met the requirements,and had good similarity.[Conclusion] During the course of prescription design of ginkgo biloba extract of sustained release preparation,the method of UV can be used to determine the content of flavonol glycosides instead of HPLC.This method is simple,accurate and reliable.

关 键 词：银杏叶提取物 紫外分光光度法 高效液相色谱法 缓释制剂 相似因子法 

分 类 号：R285[医药卫生—中药学]