Study On The Quality Evaluation Method Of Peucedani Radix And Processing Method Of Rhei Radix Et Rhizoma

As an important part of the Traditional Chinese Medicine(TCM)system,the quality of TCM has become one of the important foundations for the development of Chinese Medicine.The quality of TCM is directly related to the clinical use.Therefore,the quality standard is the criterion to ensure the safety,effectiveness and stability of clinical medicine.Based on the quality control system of the whole industrial chain,the quality evaluation of herbal medicines is particularly important.In order to ensure the safety and effectiveness of public medicinal use and the healthy development of Chinese Medicine,with the rapid development of spectroscopy and chromatographic analysis techniques,the quality evaluation methods and control levels of Chinese Medicine have also been significantly improved.However,there are still some problems,such as the qualitative and quantitative methods of a single index component sometimes hard to truly and comprehensively reflect its clinical efficacy.The mixed use of cultivated and wild products has also caused large differences in the quality of collected herbal medicines between batches.The first part of this thesis is financially supported by the National Key Research and Development Program "Research on Modernization of Traditional Chinese Medicine".Through the collection of Peucedani Radix medicinal materials from different origins,the quality evaluation methods of thin layer chromatography,HPLC fingerprint and content determination of Peucedani Radix were established,for the further USP international standard research.The second part is research on the processing method of Rhei Radix et Rhizoma in Yiling Pharmaceutical Company’s new Chinese Medicine Compound Prescription project,based on the "Guiding Principles for Research on Quality Standards of New Chinese Medicines(Trial)" and Chinese Pharmacopoeia 2015 edition.After the quality evaluation of Rhei Radix et Rhizoma harvested from planting base in Gansu,the laboratory experiment combined with the company’s workshop conditions,the processing method of raw rhubarb decoction pieces was optimized.The produced decoction pieces were also evaluated for their quality and stability.The fingerprint was established as an internal control standard,and combined with chemical identification methods to distinguish the different Rhei original plants and processing products.1.Research on Quality Evaluation Method of Peucedani RadixBased on the comprehensive comparison of different Pharmacopoeia and medicinal material standards in various countries and regions,a TLC method establishing for the identification of Peucedani Radix,24 batches show three fluorescent spots of the same color on the corresponding position with the reference substances,which can be used to distinguish Peucedani Radix and its fake products.The fingerprint chromatogram was established with 9 common peaks,and 3 of them were identified as Praeruptorin A,Praeruptorin B and Praeruptorin E by using reference substances,The batch similarities are greater than 0.9.The determination of content was also established with a simpler sample preparation method.The content range of Praeruptorin A is 0.80%to 1.20%,and for Praeruptorin B,it is 0.15%to 0.22%.The moisture is not more than 12.0%,and the extract is not less than 20.0%.2.Research on the Processing Method of Raw Rhubarb11 batches of Rhubarb provided by Yiling Pharmaceutical company for processing method research were all meet the testing requirements in Chinese Pharmacopoeia.The processing method of raw rhubarb is established as:firstly,take the medicinal materials,classify the size,remove impurities,and wash quickly.The drenching method is sprayed in stages:once 1 hour for the first 5 times on small pieces and the first 10 times on big pieces.then swith to once 2 hours until the water absorption of the medicinal materials is not less than 30%.Cut as 2-4 mm thick slices and dry at 40±5℃ until the loss on drying is less than 15.0%,take out to allow to cool,sieving and packing.11 batches of decoction pieces from pilot scale meet the requirements of the Chinese Pharmacopoeia and were stable after 12 months investigation.The fingerprint chromatogram was established with 14 common peaks,9 of them were identified as,gallic acid,catechin,sennoside B,sennoside A,aloe-emodin,rhein,emodin,chrysophanol and physcion by comparing with reference substances,The batch similarities are greater than 0.9.Fingerprint with cluster analysis and principal component analysis can be used to distinguish three different original plants of Rhei and their processing products.3.SummaryThe chemical components of Peucedani Radix from different areas are similar,but the content is kind of low.Peucedani Radix circulating on the market has many confused products,such as shoddy and adulterated products.Their poor quality needs a strengthened market supervision.Representative medicinal materials should be provided for experiment research,with corresponding data to support Peucedani Radix for the international Pharmacopoeia.The processing method of Rhei Radix et Rhizoma was established together with UPLC fingerprint for internal quality control.The new fingerprint chromatogram can be used to effectively evaluate the quality of Rhei Radix et Rhizoma,providing upport for the research development of new drugs.