Determination Of Prim-o-glucosylcimifugin As Well As Imperatorin In Biyan Tablet And HPLC Fingerprint Of The Saposhnikoviae Radix

Biyan Tablet is traditional proprietary Chinese medicine, it is made up of 11 kinds of Chinese Herbs, such as Xanthii Fructus, Radix Saposhnikoviae, Angelicae Dahuricae Radix, Schisandrae Fructus, Forsythiae Fructus, Platycodon grandiflorus Radix and so on. This drug is used for acute and chronic rhinitis wind hot accumulates lung disease whose curative effect is distinct.This thesis controls the quality standards of Biyan Tablet from two aspects. Base on China pharmacopoeia 2010 edition with reference to new drug of TCM requirements for review, the HPLC determination for identification of prim-o-glucosylcimifugin and imperatorin are added. And the assaying method for the optimum preparing conditions and determination is established. The paper help to establish the quallty standard of Biyan Tablet, all of these are done to establish a reasonable, normative and scientific quality control system for Biyan Tablet The content determination method is simple, accurate, high sensitivity, and controllable. The normative quality specification is offered to industrialized great production.To establish a systematic and regular quality evaluation system to control the quality of Saposhnikoviae Radix in this experiment utilizes RP-HPLC to study the fingerprints and establishes the qualitative as well as qualitative menthods of Saposhnikoviae Radix. The fundamental factor which affects the quality of traditional Chinese medicine is the existence of active components. The quality of traditional Chinese medicine can be completely analyzed by means of applying the HPLC to measure it. In this paper, through 10 batches from different habitats of Radix Saposhnikoviae collected from different areas we can exam a sample of the extraction conditions such as extraction method, extraction solvent, extraction time etc. In the control good extraction conditions, can be extracted single-minded, completely total extract to get repetitive higher HPLC fingerprint, SPSS statistical software clustering analysis and analysis of different quality medicinal herbs, which can provide basis for the production of choice.The results complement the quality standard of Biyan Tablet, and the method provided for the quality control of Biyan Tablets is so accurate and reasonable that can provides an objective basis for the export of Biyan Tablet to EU. In addition, this result also establishes an exact and convenient fingerprint which can provide scientific basis for choose the better quality of Saposhnikoviae Radix.