| Kangmin granules, consisted of Cortex Dictamni, Cortex Pheliodendri, Cortex Moutan, Radix Astragali, Radix Paeoniaae Rubra, Rhizoma Atractulodis Macrocephalae, Radix AngeLica Sinensis and Scorpio, is one of traditional Chinese medicine recipe for clearing heat and detoxicating. In this thesis, method of qulity control and the pharmacokinetics of paeonol in decoction were studied.RP-HPLC methods were used to determine the content of peoniflorin in Radix Paeoniaae Rubra, calycosin in Radix Astragali, ferulic acid in Angelica Sinensis, paeonol in Cortex Moutan, fraximellone in Cortex dictamni and berberine in cortex pheliodendri in Kangmin granules. The determination was accomplished by different mobile phase system in Kromasil C18 columns. The linear ranges were 0.181-3.62 mg·mL-1 (r=0.9992),1.59-31.8μg·mL-1 (r=0.9995),8.04-160.9μg·mL-1 (r=0.9994),0.54-10.8μg·mL-1 (r=0.9991),1.11-22.2μg·mL-1 (r=0.9995) and 10.28-205.6μg·mL-1 (r=0.9997), respectively; The recoveries were 99.3%(RSD=1.2%),100.1%(RSD=1.7%),100.8%(RSD=1.8%), 100.2%(RSD= 1.1%),99.7%(RSD=0.8%)and 100.2%(RSD=1.2%), respectively. The crude herbs used were proved qualified and provide a quantitative basis for the quality assessment for Kangmin granules.The optimal ethanol extraction process of Kangmin granules was studied by orthogonal design with extractive yield and the contents of peoniflorin, calycosin, ferulic acid, paeonol, fraximellone as markers. Three factors were studied in this experiment, including the concentration of ethanol, the solvent consumption, and times of extraction. The result showed that the optimal extracting condition was 75% ethanol consummated ten times the amount of material, and two times for 1 hour each time.RP-HPLC methods were established to simultaneous determine peoniflorin in Paeonia veitchii, calycosin in Astragalus membranaceus and ferulic acid in Angelica sinensis; paeonol in Paeonia suffruticosa and fraximellone in Cortex dictamni in Kangmin granules. The determination could be accomplished by different mobile phase system in Kromasil C18 columns. The linear ranges were 180-3600μg·mL-1 (r=0.9992).4.6-92.0μg·mL-1 (r= 0.9991) and 8.0-160.0μg·mL-1 (r=0.9994); 0.54-10.8μg·ml-1 (r=0.9991) and 1.11-22.2μg·ml-1 (r=0.9995), respectively;The recoveries were 98.3%(RSD=1.8%).99.0 %(RSD=2.0%)and 100.5%(RSD=1.1%); 99.9%(RSD=2.1%) and 100.3%(RSD =1.3%), respectively. The contents were:15.50 mg·g-1,0.415 mg·g-1,1.1 mg·g-1,0.0502 mg·g-1,0.108 mg·g-1, respectively. The assay methods are simple, rapid and with good reproducibility and provide a quantitative basis for the quality assessment for Kangmin granules.HPLC-UV method for determination of paeonol in rat plasma were validated and applied to pharmacokinetic research on Kangmin granules. The separation was achieved on a Kromasil C18 (250 mm×4.6 mm,5μm) column at room temperature. The mobile phase consisted of acetonitrile-0.1% phosphoric acid solution (75:25, v/v) at a flow rate of 1.0 mL·min-1. The UV detection wavelength was set at 274 nm. The extraction recoveries exceeded 76%. Linear calibration plot was obtained in the concentration range from 2.48 to 124μg·mL-1(r>0.996). Intra-day RSD and inter-day RSD were both less than 13.2%. The method is simple, special, accurate and reproducible.Paeonol showed two-compartment model in rat after intragastric administration. After administration of decoction, t1/2αwas 1.218 h, t1/2βwas 10.4 h, Cmax was 21.62μg·mL-1, AUC was 18.36μg·h·mL-1. |
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