<正>沈阳中海药业有限公司组建于2006年,是以新药研发为核心能力、崇尚自主创新的药品生产企业。公司位于沈阳新民经济技术开发区,占地面积68000平方米,建筑面积15000平方米,由全国四所甲级医药设计之一的吉林医药设计院历时一年半完成整体设计,全面完成选址、立项、审批、环境评价、安全评价、防雷、建筑规划许可、图纸审核、施工许可等一系列施工前手
The study on chiral drugs has become one of new directions of new drugs research internationally.Analysis of chiral drugs,with increasing in importance in pharmaceutical research,is now a hot and difficult topic in international analysis science.Chiral ligand-exchange chromatography(CLEC)is one of the most popular methods to direct separation of enantiomers.This paper presents a review of the application research of CLEC in chiral separation of drug enantiomers and a discussion of the developments prospect of this technique.
The compositions of Cu(Ⅱ) and L-His binary complex and Cu(Ⅱ)-L-His and chiral drug ternary complex were determined by UV spectrophotomtry.The UV spectral property of complex was also studied.The effects of different pH of solution on the stability of complex were investigated.The ratios of composition of Cu(Ⅱ) and L-His binary complex and Cu(Ⅱ)-L-His and chiral drug ternary complex were 1:2 and 1:1:1,respectively.The complex was more stable under basic condition.The enantiomers of pantoprazole were separated with a resolution of 1.4 by high performance liquid chromatography with Cu(Ⅱ)-L-His as chiral additive on a conventional C18 column.
Objective To establish digitized chromatography fingerprint of Ixeris chinensis by HPLC.Methods Reversed phase HPLC was applied on a CenturySIL BDS column(200 mm× 4.6 mm,5 μm) with the mobile phase A(1% acetict acid-water) and B(1% acetic acid-methanol) with a gradient elution.The flow rate was 1.0 mL·min-1,the UV absorbance was monitored at 265 nm by injecting 5 μL of the sample solution each time and the column temperature was maintained at(30 ±0.15) ℃.The chromatographic fingerprints were charateristically digitized and evaluated by the software of the digitized evaluation system of Traditional Chinese Medicine fingerprint with the super information characteristics to provide 42 parameters such as chromatographic fingerprint index(F),chromatographic fingerprint resolution index(RF),which could thoroughly disclose the hidden information in the fingerprints.Meanwhile,the apparent molecular weight,peak position,elution fore index and pseudo peak areas were marked in terms of the principle of QSPR when 2 peaks were selected as the referential peaks.Results Thirty-two co-possessing peaks were selected as the fingerprint peaks of Ixeris chinensis by taking caffeotannic acid peak as the referential peak to establish the digitized fingerprint and to obtain the important digital information for its quanlity control.The stabilities among different lots of samples were evaluated by the dual qualitative and dual quantitative similarity method.Conclusion The method can clearly display the hidden information in this HPLC fingerprint,and can provide a reference for the quality control of Ixeris chinensis.
