注射用丹参粉针剂-中间体-药材HPLC指纹图谱及其相关性研究  

HPLC fingerprint chromatograms of Danshen Injectable Powder,intermediate and crude Danshen(Radix Salviae Miltiorrhizae) and correlation among them

作　　者：张晓茹[1] 王宝华[1] 宋歌[1] 冉晓萌[1] 杨璇[1] 邵露[1] 

机构地区：[1]北京中医药大学中药学院,北京100102

出　　处：《北京中医药大学学报》2011年第11期769-774,共6页Journal of Beijing University of Traditional Chinese Medicine

基　　金："十一五"国家科技支撑课题资助项目(No.2006BAI09B07);北京中医药大学复方中药制药研究创新团队项目

摘　　要：目的建立丹参药材、注射用丹参中间体及粉针剂的指纹图谱。方法 HPLC法,大连依利特Hypersil BDS C18色谱柱(250 mm×4.6 mm,5μm);流动相:乙腈-0.1%磷酸,7∶93(0→5 min),12∶88(5→7 min),12∶88(7→20 min),17∶83(20→22 min),17∶83(22→42 min),20∶80(42→60 min),22∶78(60→90 min);测定波长:281 nm;流速:1.0m L/min;温度:30℃。结果建立了注射用丹参粉针剂-中间体-药材HPLC指纹图谱,计算了不同批次药材、中间体、粉针剂间的相似度,相似度均大于0.95。利用相似度评价软件评价了药材、中间体、粉针剂间的相关性,相关性良好。结论在确定的液相色谱条件下的指纹图谱信息完全,分离度良好,注射用丹参粉针剂间的相似度良好,表明该制备工艺下的丹参粉针剂产品质量良好。Objective To establish the fingerprint chromatograms of crude Danshen（Radix Salviae Miltiorrhizae）,intermediate and Danshen Injectable Powder.Methods The HPLC procedure was performed on the chromatographic column of Hypersil BDS C18（250 mm×4.6 mm,5 μm）,and the mobile phase was acetonitrile and 1% phosphoric acid [7∶ 93（0-5 min）,12∶ 88（5-7 min）,12∶ 88（7-20 min）,17∶ 83（20-22 min）,17∶ 83（22-42 min）,20∶ 80（42-60 min） and 22∶ 78（60-90 min）] in gradient elution.The detection wavelength was 281 nm,flow velocity,1.0 mL/min and temperature,30 ℃.Results The fingerprint chromatograms of crude Danshen,intermediate and Danshen Injectable Powder were established,and similarities of different batches of crude Danshen,intermediate and Danshen Injectable Powder were calculated,which were all above 0.95.The correlation among crude Danshen,intermediate and Danshen Injectable Powder was reviewed by applying the software of similarity evaluation,and the result showed that the correlation was good.Conclusion The fingerprint chromatograms had complete information under the defined HPLC condition with a good separating degree.Danshen Injectable Powder had good similarity,which indicated that quality of the products prepared under this condition was excellent.

关 键 词：丹参 粉针剂 中间体 指纹图谱 相似度 

分 类 号：R283.6[医药卫生—中药学]