基于HPLC指纹图谱的系统指纹定量法评估复方丹参滴丸质量  

Quality evaluation of compound Danshen dropping pills by systematic quantified fingerprint method based on HPLC fingerprints

作　　者：孙国祥[1] 宋宇晴[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《中南药学》2009年第4期297-300,共4页Central South Pharmacy

基　　金：国家自然科学基金重大研究计划课题(90612002)

摘　　要：目的建立复方丹参滴丸(CDDP)的HPLC指纹图谱,以系统指纹定量法评价其质量。方法采用RP-HPLC法,通过测定10批CDDP生成对照指纹图谱(RFP)并用系统指纹定量法评价其质量。结果以原儿茶醛为参照物峰,确定15个共有指纹峰,用系统指纹定量法鉴别出质量好的有4批,质量中等有4批,2批因含量高致使其质量被划为一般。结论基于HPLC指纹谱的系统指纹定量法可有效控制CDDP质量。Objective To establish an HPLC fingerprint of compound Danshen dropping pills （CDDP） using systematic quantified fingerprint method to control the quality. Methods The reference fingerprint （RFP） was synthesized from 10 batches of CDDPs which were evaluated by systematic quantified fingerprint method. Results Fifteen co-possessing peaks were selected as the fingerprint peaks of CDDP when taking protocatechualdehyde peak as the reference peak to establish the HPLC, in which 4 of the 10 batches were good while another 4 batches were moderate. The contents of S9 and S10 were obviously higher and were classified as general quality by systematic quantified fingerprint method. Conclusion Systematic quantified fingerprint method based on HPLC fingerprint can effectively control the quality of CDDP.

关 键 词：系统指纹定量法 复方丹参滴丸 HPLC指纹图谱 宏定性相似度Sm 宏定量相似度Pm 色谱指纹图谱相对指数Fr 

分 类 号：R284[医药卫生—中药学] O234[医药卫生—中医学]