| Migan granules, consisted of Phellodendron amurense Rupr, Bupleurum chinense DC, Polygonum aviculare L, Taxillus chinensis (DC.) Danser, Dipsacus asperoides, Fructus Schisandrae, Fructus Malvae, Radix Angelicae Dahuricae, Licorice root, is one of traditional chinese medicine recipe for improving frequent micturition, urgent micturition and dysuria. In this dissertation, method of qulity control and the pharmacokinetics of Schizandrin in plasma of rats were studied.Three medical materials in Migan granules, including Phellodendron amurense Rupr, Bupleurum chinense DC, Dipsacus asperoides, were identified by thin layer chromatography. RP-HPLC methods were established to determine, simultaneously, berberine hydrochloride and quercetin, sweroside and liquiritin, asperosaponinVI, schizandrin, deoxyschizandrin and y-schizandrin in Migan granules, respectively. The determination could be accomplished by different mobile phase system in Diamonsil C18 columns. The linear ranges were 1.040 10.40μg·mL-1 (r=0.999 9),0.4000-4.000μg·mL-1 (r=0.999 8),0.5880μg·mL-1-4.704μg·mL-1 (r=0.9999),2.926μg·mL-1-23.41μg·mL-1 (r=0.9994),100-1000μg·mL-1(r= 0.999 9),10.952-109.5μg·mL-1(r=0.999 5),0.8400-8.400μg·mL-1(r=0.999 1) and 0.6600-6.600μg·mL-1(r=0.9995), respectively. The recoveries were 98.5%(RSD=0.93 %),98.8%(RSD=1.43%),99.5%(RSD=0.94%),99.4%(RSD=0.65%),102.4% (RSD=0.88%),99.2%(RSD=1.14%),99.0%(RSD=1.42%) and 99.7%(RSD=1.07 %), respectively. The contents were 14.64μg·g-1,8.175μg·g-1,0.3471μg·g-1,2.977μg·g-1, 387.3μg·g-1,42.14μg·g-1,4.653μg·g-1,3.684μg·g-1, respectively. The assay methods are simple, rapid and with good reproducibility and provide a quantitative basis for the quality assessment for Migan granules.Determination of schizandrin in rats plasma was applied to pharmacokinetic research by HPLC-UV. The HPLC separation was achieved on a Diamonsil C18 (200 mm×4.6 mm,5μm)column at 35℃. The mobile phase consisted of methol-water (70:30, v/v) at a flow rate of 1.0 mL·min-1. The UV detection wavelength was set at 250 nm.The extraction recoveries at the concentration of 0.2960,1.480 and 11.84μg·mL-1 were 75.9%,77.3% and 82.5%, respectively. A linear calibration plot was obtained in the concentration range from 0.1480 to 14.80μg·mL-1(r=0.997 7). Within-day RSD and inter-day RSD were both less than 10%. The extraction recoveries exceeded 75.9%. The method is simple, special, accurate and reproducible.Schizandrin showed different pharmacokinetic characteristic in rats plasma after introgastric administration of different decoction, solution of decoction of Fructus Schisandrae and Migan granules. Schizandrin showed two-compartment model after introgastric administration of decoction of Fructus Schisandrae and one-compartment model after introgastric administration of decoction of Migan granules. After administration of decoction of Migan granules, Tmax was 1.125±0.2622 h h, Cmax was 5.506±1.502μg·mL-1. AUCo-t was 11.58±3.291μg·h·mL-1. AUC0â†'∞was 12.36±3.279μg·h·mL-1, t1/2 was 1.416±0.3577 h. After administration of decoction of Fructus Schisandrae, Tmax was 0.9167±0.2582 h, Cmax was 4.917±1.262μg·mL-1. AUC0â†'t was 9.267±2.422μg·h·mL-1. AUC0â†'∞was 10.28±2.645μg·h-mL-1, t1/2 was 1.812±0.3198 h. But the result show no significant difference in the statistical moment parameters. |
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