Study On The Quality Standard And The Material Basis Of The Chinese Medicine Prescription

Chinese medicine prescription is a a kind of Biotech drugs which made of appropriate medicinal odour and dosage, according to the "traassistant and guide"of principles of formulating prescription under the theory of traditional Chinese medicine by the ancient Chinese medicine doctors.The validity of the Chinese Medicine Prescription is proved in the clinical research.Now, Chinese medicine prescription is already widely accepted. Establishing the quality control method of the Chinese medicine prescripition is extremely important.In this dissertation, Xiaobaidu Concentrated Decoction ( XBD Concentrated Decoction),Fuke Huisheng Pills (FKHS Pills)and Ganmao Qingre Granule(GMQR Granule) are selected as the object of study. XBD Concentrated Decoction and FKHS Pills are about to be written in the pharmacopoeia of China,which were recorded in the Ministry of Health's drug standard catalogue of China.The GMQR Granule is already recorded in the pharmacopoeia of people's republic of china(2005,part one).First, on the current principle of the pharmacopoeia of China for estabilishing new drug standard, the new quality control standards of XBD Concentrated Decoction and FKHS Pills were estabilished on the basis of their previous standard.For the GMQR Granule,a extend study was done following the modern quality control trend. The method for determine several compound and the fingerprint of the GMQR Granule was set up,and then use the TOF-MS technique for analysis of it's chemical constituents, lie a foundation for build a consummate quality control method.1. Elevate the quality control standard of the Chinese Medicine Prescription(1) Elcvate the quality control standard of XBD Concentrated DecoctionSet up the TLC identification method of Rheum tanguticun Maxim.ex Balf, Lonicera japonica Thunb,Taraxacum mongolicun Hand.Mazz,Phellodendron chinense Schneid,Citrus reticulata Blanco and Radix Paeoniae Rubra.The blank contrast show that other Materia Medica were non-interfering, this method is easy and simple to handle with a good specificity and repeatability.And the method for determination of the emodin and chrysophanol by HPLC in this prescription was set up while there no such verification item before.(2) Elevate the quality control standard of the FKHS PillsSet up the microscopical chatacteristics method of Radix Et Rhizoma Ginseng and Poria, and the method for identificate the Rheum officinale Baill, Atractylodes lancea (Thunb.)DC., Angelica sinensis (Oliv.)Diels, Ligusticum chuanxiong Hort was established by TLC. And the method for determination of the emodin and chrysophanol by HPLC in this Prescription was set up. Ther are only appearance description and other inspection items in its former standard.Build this quality control method elevating the quality control level.2 Extend study for the quality control of the Chinese medicine prescription(1) The quantitative method of several ingredients in GMQR Granule A quantitative method of four isoflavonids in GMQR Granule,including puerarin, daidzin, genistin and daidein were developed by HPLC-UV,which reflect contents of isoflavonids in GMQR Granule, control and evaluate the quality of Chinese medicinal prescription.The results indicated that the contents of four isoflavonids in GMQR Granule varied greatly.(2) The study of the HPLC fingerprint of the GMQR granuleEstablish the HPLC fingerprint of GMQR granule. Through comparing and analyzing the relative retention time of this decoction and of its composition which are positive and negative control fingerprints,the main chromatographic peak origins were confirmed;The correlated chromatographic peaks were identified by contrasting chromatographic peak retention time and adding reference substances to the sample. Use chemometrics to quality consistency evaluation of GMQR Granule produced by different manufacturers.(3) HPLC-TOF-MS analysis of chemical constituents of GMQR GranuleThe chemical constituents of the extracts was analyzed with RRLC-TOF-MS, 32 peaks were identificed. Provide a feasible method for the chemical material basis study wihich can used to set up the veridical chemical fingerprint.This research indicate the chemical material basis of the GMQR granule.