Study On The Method Of Quality Assessment Of Radix Paeoniae

Radix Paeoniae belonging to rannunculaceae palnts, one of Chinese crude drugs collected by Chinese Pharmacopeia (2010), is the dry root of paeonia lactiflora pall and paeonia veitchii lynch. With active component of peoniflorin, it has a good effect on removing heat to cool blood, eliminating stasis to activate blood circulation and relieving pain. According to pharmacology study, Radix Paeoniaecan not only be antithrombotic and degread endotoxin and tumor necrosis factor for patients with serious hepatitis,but also improve biochemical indicator of liver, calm patients, relieve pain and be anti convulsion and inflammatory and tumor. In addition, it is used in clinic extensively for lots of Chinses formulated products which include paeoniae radix, such as broth, tablets, granule and mixture. Recently, Peoniflorin Injection is being researched in the pharmaceutical area.Collecting 40 Radix Paeoniaesamples from different places of production, extraction and purification of penoniflorin based on its components requirement are adopted in this study. What's more, measurement and comparison of different samples provide process references for it. Meanwhile, under the indefinity of active components, depending on the overall role of too much chemicial composition, the researcher conducts a finger printing study of Radix Paeoniaethat was regared as an "entirety" to make classifying researches according to the quality and to establish a quality control plan, which became the resource of Chinese crude drugs selection and purchase. Research contents were elaborate as follows:1. Comapred to the extraction efficiency of water, methanol and different concentration of ethanol, extraction methods resrcearch of penoiflorinfor, an active component of Radix Paeoniaeis conducted in the trial. According to the result, it indicated that 70% of ethanol is the best. What's more, the researcher also optimizes its extraction dose, time and number of times by orthogonal design based on the comparion of 70% of ethanol, an estraction solvent, and discovers the best extraction condition that 10 times of 70% of ethanol is used to extract it for 3 times with hyopersound in 1h/time. This method ensures not only the highest extraction efficiency, but the convenient use. 2. Purification methods research of Radix Paeoniaeextrat is also conducted in the trial. With HPD-300 macroporous adsorptive resins and orthogonal design, the researcher makes an observation of its concentraction, adsorption rate, elution rate and elution parametric of resin height ratio. According to the result, the best process condition,1.0g/ml of concentration, 1:10 of resin height ratio,4BV/h of applicating samples speed,5BV/h of elution speed, can make elution efficiency reach to above 80%.3. To research the relationship of peoniflorin contents of Radix Paeoniaeand its places of production, HPLC is adopted in the study from Chinese Pharmacopeia in room temperature by making MetaChem Kromasil C18 (4.6mm X 250 mm,5μm) as chromatographic column,-0.05 mol/L of methanol and KDP(32:68) as mobile phase,229nm as wave length, peoniflorin as the reference and peak area of reference substances as Y-axis,concentration as X-axis. As a result, its regression equation is Y=106.22 X+193.35, r=0.9993. And with excellent resolution, convenient method and fine reproducibility, peoniflorin would be in good linear relationship. According to the study, it indicated that the higest peoniflorin content of Radix Paeoniaecomes from Inner Mongolia, and then from Liaoning, Jilin and Heilongjiang.4. To establish a good method to classify its quality, research for fingerprints of Radix Paeoniaesamples and systematic cluster analysis are adopted in the study. Collecting 40 kinds of HPLC chromatographic fingerprints, the research has separated 25 and received the whole chemical data by systematic cluster analysis with DPS, a piece of statistical software. Therefore, according to the result, the quality of Radix Paeoniaeis classified 3 degreees, fine quality, common quality and poor quality. And 3 discriminant functions which have been formed in the research through stepwise discriminate analysis are as follows: Y1=-34.0112+17.51×X1+72.3921×X7-146.0773×X9+147.0177×X11+25.8711×X14; Y2=-3.4159-0.5246×X1+18.7094×X7+18.6650×X9+2.4383×X11-12.4320×X14; Y3=-262.6948+69.6192×X1+315.5969×X7-365.6156×X9+587.2904×X11+531.7006×X14In addition, the researcher also conducts a verification experiment for clustering methsods and discriminant functions. On the conclusion, the result of cluster analysis is conformed to that of related fuctiions, which could ensure 100% of accuracy of verification experiment.