| Shiweihuoxue pill composed of ten commonly used Chinese herbs:Chinese Angelica, Peach Seed, Safflower, Dried Tangerine peel, Divaricate Saposhnikovia Root, Common Aucklandia Root, Dahurian Angelica Root, Nutgras Galingale Rhizome, Yanhusuo and Radix Glycyrrhizae, is one of traditional Chinese medicine recipe for promoting blood flow and relieveing pain. It has been used clinically to the treatment of fall, congestion and swelling pain. In this thesis, RP-HPLC was employed in quality control of index components in Shiweihuoxue pill. A HPLC-UV method was developed for studying pharmacokinetics of Shiweihuoxue pill in rats.RP-HPLC methods were established to determine ferulic acid, hesperidin, 5-0-methylvisammioside, imperatorin, dehydrocostuslactone, isoimperatorin, amygdalin, hydroxysafflor, prim-O-glucosylcimifugn, liquiritin, tetrahydropalmatine in Shiweihuoxue pill. The calibration curve was linear within the range of 1.80 to 18.0μg·mL-1 for ferulic acid (r= 0.999 8),40.0 to 400μg·mL-1 for hesperidin (r=0.9997),3.00 to 30.0μg·mL-1 for 5-0-methylvisammioside (r=0.999 9),0.299 to 2.99μg·mL-1 for imperatorin (r=0.9998), 1.36 to 13.6μg·mL-1 for dehydrocostuslactone (r=0.999 7),0.165 to 1.65μg·mL-1 for isoimperatorin (r=0.999 7),2.40 to 24.0μg·mL-1 for amygdalin (r=0.9998),1.76 to 17.6μg·mL-1 for hydroxysafflor (r=0.999 7),2.86 to 28.6μg·mL-1 for prim-O-glucosylcimifugn (r=0.999 7),0.774 to 7.74μg·mL-1 for liquiritin (r=0.999 9),1.04 to 10.4μg·mL-1 for tetrahydropalmatine (r=0.999 8). The average recoveries were 101.6%(RSD=1.8%) for ferulic acid,99.9%(RSD=1.4%) for hesperidin,98.0%(RSD=1.6%) for 5-O-methylvisammioside,100.3%(RSD=0.88%) for imperatorin,99.7%(RSD=1.1%) for dehydrocostuslactone,99.6%(RSD=0.84%) for isoimperatorin,99.9%(RSD=1.2%) for amygdalin,99.1%(RSD=1.5%) for hydroxysafflor,99.2%(RSD=1.8%) for prim-O-glucosylcimifugn,99.0%(RSD=1.6%) for liquiritin, and 98.9%(RSD=1.1%) for tetrahydropalmatine. The assay methods are simple, rapid and with good reproducibility, which provide a quantitative basis for the quality assessment for Shiweihuoxue pill.The method of determine hydroxysafflor in rat plasma after i.g. administration of Shiweihuoxue pill was developed to study the pharmacokinetics by using 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-0.2% phosphonic acid (35:65, v/v) at a flow rate of 1.0 mL·min-1. The UV detection wavelength was set at 320 nm. Linear calibration plot was obtained in the concentration range from 0.100 to 10.0μg·mL-1 (r=0.9968). Intra-day RSD and inter-day RSD were both less than 7.2%. The extraction recoveries of hydroxysafflor exceeded 70.2%. The pharmacokinetic parameters were achieved as follows:Cmax was 1.815±0.841μg·mL-1, Tmax was 0.875±0.877 h, AUC0-t was 6.089±2.861μg·h·mL-1, AUC0-∞was 8.463±1.786μg·h·mL-1. Hydroxysafflor could be absorbed rapidly and its pharmacokinetics was consistent with one-compartment model. The method is simple, accurate and reproducible, which was suitable for the preclinical pharmacokinetics study of hydroxysafflor in rats. |
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