Quality Control Methods. The Shenqi Liver Health Capsules And Pharmacokinetic Studies

Shenqigankang capsule, consisted of Herba Artemisiae Scopariae, Radix Codonopsis, Fructus Silybi, Fructus Schisandrae Chinensis, Radix Angelicae Sinensis,Radix Astragali and Radix Et Caulis Acanthopanacis Senticosi is one of traditional Chinese medicine recipe for clearing heat,harmonizing liver and spleen. In this dissertation, The qulity control method and the pharmacokinetic research were studied.RP-HPLC methods were developed and validated to determine 6,7-dimethoxycoumarin in Herba Artemisiae Scopariae, ferulic acid in Radix Codonopsis in Shenqigankang capsule. The determination could be accomplished by different mobile phase system in ODS columns. The linear ranges were 14.9-149μg-mL-1 (r= 0.9992),1.60-16.0μg·mL-1 (r= 0.9992), respectively. The recoveries were 96.4%(RSD= 1.8%),100.4% (RSD= 2.0%), respectively.The optimal ethanol extraction process of Shenqigankang was studied by orthogonal design with extractive yield and the contents of 6,7-dimethoxycoumarin, ferulic acid, silybin,deoxyschizandrin, schizandrin B as maekers. Three factors were studied in this experiment, including the concentration of ethanol, times of extraction and time of reflux. The result showed that the optimal extracting condition was 90% ethanol consummated ten times the amount of material, and two times for 1 hour each time.RP-HPLC methods were developed and validated to determine ferulic acid, 6,7-dimethoxycoumarin, silybin, deoxyschizandrin and schizandrin B in Shenqigankang capsule. The determinations were accomplished using different mobile phase systems on Diamonsil C18 columns. The linearity ranges were 0.060-12μg-mL-1 (r= 0.9998), 1.808-361.6μg·mL-1 (r= 0.9999),12.0-240μg-mL"1 (r= 0.9997),10.0-200μg-mL-1 (r= 0.9994) and 4.00-80.0μg-mL-1 (r= 0.9996), respectively. The recoveries were 98.5% (RSD = 1.3%),99.4%(RSD= 2.0%),97.0%(RSD= 1.9%),98.4%(RSD= 1.7%) and 99.2% (RSD= 1.3%), respectively. The contents were 0.0458,1.48,0.457,0.441 and 0.162, respectively.Determination of 6,7-dimethoxycoumarin in rat plasma was applied to pharmacokinetic research by using HPLC-UV and coumarin was used as internal standard. Acetonitrile was used to precipitate protein. The HPLC separation was achieved on a Diamonsil C18 (200 mm ×4.6 mm,5μm) column at 25℃. The mobile phase consisted of acetonitrile-0.5%glacial acetic acid solution (26:74, v/v) at a flow rate of 1.0 mL-min-1. The UV detection wavelength was set at 340 nm. The mena extraction recovery exceeded or equaled 90.6%. Linear calibration curve was obtained in the concentration range from 0.152 to 15.2μg-mL-1 (r> 0.9915). Intra-and inter-day RSD were both less than 8.7%. After intragastric administration of Shenqigankang capsule,6,7-dimethoxycoumarin showed two-compartment model, t1/2 was 3.42 h, Cmax was 3.32μg-mL"1, AUC was 5.92μg-h-mL"1.