Study On The Method Of Quality Assessment And Pharmacokinetics Of Xinning Tablet

Xinning tablet is prepared from Radix Notogingseng, Flos Carthami, Rhizoma Chuanxiong, Red Peony Root, Salvia Miltiorrhiza, Sophora Flower and Jiangxiang. It is widely used in the treatment of the coronary heart disease and angina pectoris in clinical research. The Radix Notogingseng, Rhizoma Chuanxiong and Salvia Miltiorrhiza in Xinning tablet were identified by TLC. In this thesis, an RP- HPLC was employed in quality control of index components in Xinning tablet. An RP- HPLC method was developed for studying pharmacokinetics of Xinning tablet in rat plasma.In this paper, Radix Notogingseng, Rhizoma Chuanxiong and Salvia Miltiorrhiza in Xinning tablet were chosen and notoginsenoside R₁, ginsenoside Rg₁, ginsenoside Rb₁, ginsenoside Re, danshensu, protocatechuic acid, ferulic acid in Xinning tablet were identified by TLC with the pots clear and reproducible.An RP-HPLC method was established to simultaneously determine paeoniflorin, ferulic acid and rutin in Xinning tablet. The linear ranges were 51.02μg·mL^-1- 510.2μg·mL^-1（r = 0.999 9） for paeoniflorin, 1.08μg·mL^-1- 10.8μg·mL^-1 （r = 0.999 9） for ferulic acid and 19.04μg·mL^-1-190.4μg·mL^-1（r = 0.999 6） for rutin, respectively. The recoveries （n = 9） of paeoniflorin, ferulic acid and rutin were 100.5% （RSD = 1.0%）, 100.4% （RSD = 0.8%） and 100.4% （RSD = 0.9%）, respectively.An RP- HPLC method was developed to simultaneously determine the contents of danshensu, protocatechuic acid and protocatechuic aldehyde in Xinning tablet. The calibration curve was linear within the range of 16.80μg·mL^-1- 130.0μg·mL^-1 （r = 0.999 9） for danshensu, 9.820μg·mL^-1- 76.00μg·mL^-1 （r = 0.999 7） for protocatechuic acid and 1.948μg·mL^-1- 15.08μg·mL^-1（r = 0.999 9） for protocatechuic aldehyde, respectively. The recoveries （n = 9） of danshensu, protocatechuic acid and protocatechuic aldehyde were 99.4% （RSD - 1.2%）, 100.4% （RSD = 1.0%） and 100.2% （RSD = 0.9%）, respectively.An RP- HPLC method was developed to determine the content of ligustrazine hydrochloride and hydroxysaflor yellow A in Xinning tablet. The calibration curve was linear within the range of 4.975μg·mL^-1- 39.60μg·mL^-1 （r = 0.999 9） for ligustrazine hydrochloride and 4.422μg·mL^-1- 35.20μg·ml^-1 （r = 0.999 8） for hydroxysaflor yellow A, respectively. The recoveries （n = 9） of ligustrazine hydrochloride and hydroxysaflor yellow A were 99.4% （RSD = 0.4%） and 100.1% （RSD = 1.1%）, respectively.The pharmacokinetics of paeoniflorin in rat after i.g. administration of Xinning tablet was studied with geniposide as internal standard by RP- HPLC method. The plasma sample was extracted with methanol. The analysis was performed on a Diamonsil C₁₈（4.6 mm×200 mm, 5μm） column with acetonitrile-water （15 : 85, v/v） as the mobile phase at the flow rate of 1.0 mL·min^-1. The column temperature is 35℃. The UV detection wavelength was set at 230 nm. The extraction recoveries at the concentration of 0.8, 4 and 32μg·mL^-1 were 90.5±0.95%, 89.5±2.3% and 90.2±0.83%, respectively. The extraction recovery of internal standard was 87.8±4.7%. Intra- day and inter- day precision （RSD） were both less than 15%. The pharmacokinetics of paeoniflorin in rat was consistent with one- compartment model.