The Quality Control Of Compound Preparations Of Traditional Chinese Medicine

Traditinal Chinese Medicine(TCM) is a treasure of our Chinese nation. Nowadays, people have paid more and more attention to TCM because of the significant therapeutic effect and little side-effect. As an important part of TCM, Chinese herbal medicine compound preparation is one of the most important means for disease prevention and therapy. Therefore, the quality control of the active ingredients is much necessary and has become a hot area of medicine research. The study on the quality control of Chinese herbal medicine compound preparation is very important for effectively improving its therapeutic effect and can also provide a theoretical basis for its efficacy and safety.This study aims to build the determination method of the active ingredients by modern separation and analysis technology, such as high-performance liquid chromatography, LC-MS. The simple, rapid and accurate analysis method will provide a scientific basis for the quality control of traditional Chinese medicine compound preparations and ensure the safety and efficacy of clinical application. Part one Determination of Polysaccharides in San-Huang-Tang-MinDecoction by Phenol-Sulfuric Acid ColorimetryObjective: To establish a method for the determination of polysaccharides in San-Huang-Tang-Min decoction and provide the basis for its quality control.Methods: Phenol-sulfuric acid colorimetry was employed using glucose as reference substance. The absorbance was tested at the wavelength of 490 nm.Results: The concentration of glucose at the range of 2.95-8.85 μg/m L had a good linear relationship with absorbance(r=0.9993).The average recovery reached to 98.2% with RSD of 2.7%. The average content of polysaccharides in San-Huang-Tang-Min decoction was 5.9 mg/m L with RSD of 2.9%.Conclusion: The method was convenient, accurate, stable and reliable, which could be used to determine polysaccharides in San-Huang-Tang-Min decoction. Part two Simultaneous quantification of 8 main active constituents inJianweixiaoshi tablets by liquid chromatography tandemmass spectrometryObjective: To develop an HPLC-MS/MS method for the determination of Campherol, Quercetin, Naringenin, Naringin, rutin, Apigenin and Chlorogenic Acid in Jianweixiaoshi tablets.Methods: Analysis was performed on a Sapphire C18 column(150 mm × 4.6 mm, 5 μm) eluted with methanol and water containing 0.3‰ formic acid in a gradient elution at a flow rate of 0.8 m L/min, and the injection volume was 10 μL. The column temperature was 30 ℃. The multiple-reaction monitoring scanning was employed for the quantification with switching electrospray ion source polarity in negative mode. The ion spray voltage was set at-4500 V and the turbo spray temperature was maintained at 650 ℃.Results: There was significant correlation between the peak area and concentration of each compound within the test range( r >0.9992). The average recoveries of the compounds ranged from 98.40% to 100.8%, with RSDs of 0.86% ~ 2.90%.Conclusion: The method was simple, accurate and highly reproducible, and can be used for the quality control of the Jianweixiaoshi tablets.