三七三醇皂苷及制剂的LC-MS指纹图谱研究  

Study on fingerprints of PTS and its preparation by LC-MS

作　　者：冷静[1] 杨华蓉[2] 林大胜 傅超美[1] 刘婧[1] 曹科[2] 万方[2] 

机构地区：[1]成都中医药大学药学院,四川成都611137 [2]成都华神集团股份有限责任公司制药厂,四川成都610225

出　　处：《华西药学杂志》2009年第5期503-505,共3页West China Journal of Pharmaceutical Sciences

基　　金：国家"十一五"科技支撑计划项目:三七通舒胶囊及糖脉康颗粒的评价研究(编号:2006BAI11B04);2007年度成都市科技计划项目:三七通舒胶囊国际化(欧盟)药品注册合作研究(编号:07GGYB074SF)

摘　　要：目的通过HPLC-MS法建立三七三醇皂苷(PTS)及其制剂三七通舒肠溶微丸胶囊的指纹图谱。方法采用梯度洗脱法,流动相为水和乙腈,检测波长为203 nm,流速为1.0 mg.m l-1,对多批PTS及其制剂进行HPLC测定和方法学考察,采用中药色谱指纹图谱相似度评价系统对测定结果进行相似度评价。采用对照品法和LC-MS法对原料药指纹图谱中的主要色谱峰进行成分鉴定。结果所建立的HPLC指纹图谱条件能分离PTS的各组分,具有较好的精密度、重复性和稳定性;各组分平均相似度大于0.9。LC-MS鉴定表明,PTS中所含主要成分为三七皂苷R1和人参皂苷Rg1、Re、R f、Rb1。结论采用LC-MS技术建立的PTS及其制剂的指纹图谱能充分展示PTS及其制剂的物质组成。OBJECTIVE To investigate the chromatographic fingerprints of protoparaxotriol saponins （FFS） and its preparation by HPLC - MS. METHODS Several batches of PTS and its preparation were determined by HPLC. The analysis was carried out on Waters Symetry Shield C18 column （250 mm × 4.6 mm ,5 μm） by gradient elution of acetonitrile and water. The detection wavelength was at 203 nm and the flow rate was 1.0 mg· ml ^-1. The similarity was analyzed by similarity evaluation system for chromatographic fingerprint of TCM. The main components of the fingerprints of PTS was confirmed by reference substance method and LC - MS. RESULTS The components of PTS can be separated well using this method. This method is precise, reproducible and stable. By similarity calculation, the similarity of samples were less than 0.9. The main components of PTS including notoginsenoside Rj , ginsenoside Rg1, ginsenoside Re,ginsenoside Rf and ginsenoside Rb1 were confirmed by LC - MS. CONCLUSION This method can fully demonstrate the components of PTS and its preparation and can be applied in the quality control of PTS and its preparation.

关 键 词：三七三醇皂苷 三七通舒肠溶微丸胶囊 指纹图谱 LC-MS 

分 类 号：R284.1[医药卫生—中药学]