Study On The Quality Criterions Of Chlorogenic Acid And Preparation,and Its Structure Validation

Chlorogenic Acid (CHA,3-O-caffeoylquinic acid) is the hydroxybenzene-acid by retracting of caffeic acid and quinic acid. Wich is one of the effective components (eg. Honeysuckle, Eucmmai ulmoides Oliv. Coffee bean. Ramee etc) .CHA have strong action: antibacterial, anticancer, antiaids and antioxidant. This article presents a systematical research on the quality control methodologies of the bulk material land the drug. The purpose of the research is to ensure the effectiveness and accuracy of the quality control process for the drug production.Firstly the research focuses on conforming the structure of the studying sample. Adopted the four spectrum techniques(UV, IR, MS, NMR(1H-NMR, 13C-NMR, DEPT-13C-NMR, 1H-1HCOSY, HMQC, HMBC) and linked with the analysis of elements, TG, DSC and X- diffraction to corroborate the structure of Chlorogenic Acid, wich is the same as its standard substance;To establish precision and accuration quality standard to direct the reseach and manufacture of CHA material and injiective preparation made in our courtry. Through in depth study of the physical and chemical properties of CHA, the research established a complete system of quality criterions for controling productive processes of the CHA.The research focuses on studies of systematical measuring methodology of relative substances, organic residul solvents and contets of the drug, Respectively.For the limitation test of residul solvents in Chlorogenic acid drug substance (methanol, ethanol, acetone and ethyl acetate), A capillary GC method was established. PEG-20M ( 30m × 0.53mm) as the analytical colum, the temperature of the injection and the detection ports is 150℃, the temperature column is 70℃,the detector is FID.The result was show that residul solvents in Chlorogenic acid raw was accord with requests of ICH.RP-HPLC was performed for the determination of raw drugs and injiective preparation. HPLC condition was the Aichrom-AQ C18(250×4.6mm i.d, 5μm)withacetonitrile-0.1%phosphate(15:85) as the mobile phase and detected at 323nm. The established content method had good linearity within the range of 1.5 μ g ml-1~80μ g ml-1(r=0.9998~0.9999),the detection limit was 0.0204ng(S/N≥3), the average recovery, the RSD of analysis precision and trpeatablibility precision were 100.4%.. 1.29% .. 1.11 % s 0.54% and 100.5% , 0.96% , 0.60% , 1.0%, respectively. An accurate, simple and suitable method had been provided for the quality control of CHA material and CHA for injection in this research.Finally, this paper studies the stability of raw drugs and injective preparation. It is convenient for determinatiog the condition of store. The result indicated: besides its related substances increasing so quickly under the high humidity (92.5%) and illumination, CHA materials and preparation are rather stable. So it should be stored at dryness, darkness and low-temperature.