Study On Quality Control And Pharmacokinetics Of Qirong Tablet

Qirong tablet composed of nine commonly used Chinese herbs:Herba Cynomorii, Herba Cistanches, Herba Epimedii, Semen Cuscutae, Fructus Lycii, Fructus Rosae Laevigatae, Fructus Ligustri Lucidi, Fructus Schisandrae Chinensis, Fructus Cnidii, is one of traditional Chinese medicine recipe for improving tonifying kidney to arrest spontaneous emission, to grow in intelligence and calm the nerves.It has been used clinically to the treatment of sexual debility and emission, impotence and prospermia, insomnia and loss of memory. In this thesis, method of quality control and the pharmacokinetics of osthole in different decoction were studied.Six medical materials in Qirong tablets,including Herba Cynomorii, Herba Epimedii, Fructus Lycii, Fructus Ligustri Lucidi, Fructus Schisandrae Chinensis, Fructus Cnidii, were identified by thin layer chromatography. RP-HPLC methods were established to determine protocatechic acid, catechin, acteoside, quercetin, hyperoside, icariin, schizandrin, imperatorin and osthole in Qirong tablets. The determination could be accomplished by different mobile phase system in Diamonsil C18 columns.The linear ranges were 1.8-18.0μg·mL-1(r=0.999 8),4.65-46.5μg·mL-1(r=0.999 7),4.05-40.5μg·mL-1(r=0.999 8),0.8-8.0μg·mL-1(r=0.999 7),2.5-25.0μg·mL-1(r=0.999 8),2.0-20.0μg·mL-1(r=0.999 5),4.0-40.0μg·mL-1(r=0.999 7),2.45-24.5μg·mL-1(r=0.999 9),16.5-165.0μg·mL-1(r=0.999 7),respectively. The recoveris were 100.1%(RSD=1.1%),99.3%(RSD=2.0%),98.7%(RSD=2.0%), 98.7%(RSD=2.1%),100.8%(RSD=1.4%),97.9%(RSD=1.1%),99.6%(RSD=1.8%), 99.5%(RSD=1.5%),98.9%(RSD=1.4%),respectively. The contents were 16.33μg·tablet-1, 47.53μg·tablet-1,45.77μg·tablet-1,11.95μg·tablet-1,81.59μg·tablet-1,62.33μg·tablet-1,67.03μg·tablet-1,51.85μg·tablet-1,317.μg·tablet-1,respectively.Determination of osthole 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,5 μm)column at 35℃.The mobile phase consisted of methanol-water (70:30, v/v) at a flow rate of 1.0 mL·min-1.The UV detection wavelength was set at 322 nm. Linear calibration plot was obtained among the concentration range from 0.014 to 1.4μg·mL-1 (r=0.993 2).Intra-day RSD and inter-day RSD were both less than 13.1%.The extraction recoveries exceeded 80.9%.The method is simple, special, accurate and reproducible.Osthole showed different pharmacokinetic characteristic in rats plasma after introgastric administration of different decoction, solution of decoction of Fructus Cnidii and Qirong tablets. Osthole showed one-compartment model after introgastric administration of decoction of Fructus Cnidii and Qirong tablets.After administration of decoction of Fructus Cnidii, Tmax was 1.667 h, Cmax was 0.7595±0.2131μg·mL-1, t1/2 was 3.12±0.702 h, Ke was 0.232±0.050 h-1, V1/F was 2.487±0.7540 L, AUC0â†'t was 3.582±0.7606μg·h·mL-1, AUC0â†'∞was 3.939±0.5857μg·h·mL-1.After administration of decoction of Qirong tablets,Tmax was 2.167 h, Cmax was 0.4895±0.0807μg·mL-1,t1/2 was 2.37±0.726 h, Ke was 0.311±0.076 h-1, V1/F was 3.416±1.030 L, AUC0â†'t was 2.099±0.5154μg·h·mL-1, AUC0â†'∞was 2.348±0.7271μg·h·mL-1.