Application And Studies On The Quality Control Of Chinese Material Medica By Chromatography

Quality is one of the critical factors that Chinese materia medica enter into the international market,and the quality determination of Chinese materia medica is an important process of their admission to China market,both of which bring forward some high requirement to the quality control of Chinese materia medica.It is a feasible approach that applying chromatography to analyzing and testing not only effective components,but also harmful components in Chinese materia medica for quality control.Referred to a lot of literatures,this paper improved the quality control method of the Composite Salvia Pellet and Gujing Pills.The main contains three parts.First.the effective component borneol in the Composite Salvia Pellet,has been analyzed by gas chromatography and high performance liquid chromatography.Borneol has volatility.So it is a mature method to determine the content of borneol by gas chromatography.But because the UV absorption spectra of borneol has no Characteristics,so it is difficult to determine it by high performance liquid chromatography directly.According to the feature of hydroxy in the borneol,it could be determined by HPLC derivatization method. By pre-column derivatization with 3,5-dinitrobenzoyl chloride,catalyzed by tertiary amine or pyridines,the intensive-UV-absorbed borneyl 3,5-dinitrobenzoate was generated.So the borneol in the Composite Salvia Pellet was determined by the two methods to validate the accuracy of the latter.The average recovery of borneol is 101.2% and RSD is 3.1%.The testing solution for assay is stable within 8 hours.The HPLC experimental results indicate that chromatographic peak areas are linear with quantity of injecting sample in the range of 1～10nmol for borneol.The average recovery rate is 99.8%and RSD is 1.6%(n=4).It can be found from contrasting that the measured contents in the two methods are equivalent,so they both can be used for the determination of borneol content.And then,the content of Paeoniflorin in Gujing Pills has been determined by applying RP-HPLC to improve the quality control method of this Chinese materia medica.A good linear relationship is in the range of 0.44～3.96μg(r=0.9999),the average recovery is 99.2%(n=5),and the repetitive RSD is 0.82%(n=5).The testing solution for assay is stable within 24 hours.The results show that HPLC can be used in the quality control of Chinese materia medica containing the effective component paeoniflorin.Finally,the organochlorine pesticide in Composite Salvia Pellet is determined by applying capillary gas chromatography.The experimental results show that a good linear relationship of the 11 organochlorine pesticides is in the range of(1.0×10^-4～5.0×10^-1)μg/ml,and the correlation coefficient is in the range of 0.9988-0.9999.The average recovery is in the range of 74.2～101.5%(n=6),and RSD is in the range of 2.4～8.7%. This method can be used for the determination of organochlorine pesticide content in Chinese materia medica.