Quality Of Shudan Capsule Control Method And Pharmacokinetic Studies

Shudan capsules, consisted of Radix et Rhizoma Rhei, Herba Lysimachiae, Fructus Aurantii Immaturus, Radix Bupleuri, Fructus Gardeniae, Rhizoma Corydalis, Radix Scutellariae, Radix Aucklandiae, Herba Artemisiae Scopariae and Mentholum, is one of traditional Chinese medicine recipe for making liver to be well, benefitting gallbladder, stopping pain, reducing fever, detoxifing and removing calculus. In this dissertation, method of qulity control and the pharmacokinetics of baicalin were studied.RP-HPLC methods were established to determine, simultaneously, naringin, hesperidin, neohesperidin and baicalin; quercetin, baicalein and wogonin; aloe-emodin and tetrahydropalmatine; rhein, emodin, chrysophanol and physcion; chlorogenic acid and geniposide in Shudan capsules, respectively. The determination could be accomplished by different mobile phase systems in Diamonsil C₁₈ columns. The linear ranges were 9.00 -180.0μg·ml^-1(r = 0.999 9), 0.800 - 16.00μg·ml^-1(r = 0.999 8), 15.40- 308.0μg·ml^-1(r = 0.999 8), 20.00- 400.0μg·ml^-1(r = 0.999 9), 0.3016 - 6.032μg·ml^-1(r = 0.999 8), 5.400 -108.0μg·ml^-1(r = 0.999 7), 1.300- 26.00μg·ml^-1(r= 0.999 8), 0.1300 - 2.600μg·ml^-1(r = 0.999 7), 4.352- 87.0μg·ml^-1(r = 0.999 9), 0.2200 - 4.400μg·ml^-1(r = 0.999 7), 0.1620 -3.240μg·ml^-1(r = 0.999 9), 0.5208- 10.42μg·ml^-1(r = 0.999 8), 0.1092 -2.184μg·ml^-1(r = 0.999 9), 0.800 - 16.00μg·ml^-1(r = 0.999 7) and 2.400- 48.00μg·ml^-1(r= 0.999 7), respectively. The recoveries were 100.0 %(RSD = 1.2 %), 99.2 %(RSD = 0.9 %), 100.5 %(RSD = 0.79 %), 101.2 %(RSD = 0.65 %), 100.0 %(RSD = 0.55 %), 100.6 %(RSD = 0.79 %), 99.8 %(RSD = 0.44 %), 100.0 %(RSD = 0.9 %), 100.1 %(RSD = 0.33 %), 100.5 %(RSD = 0.9 %), 100.4 %(RSD = 0.51 %), 100.8 %(RSD = 0.29 %), 99.8 %(RSD = 0.47 %), 100.0 %(RSD = 0.9 %) and 100.1 %(RSD = 0.77 %), respectively. The assay methods are simple, rapid and with good reproducibility and provide a quantitative basis for the quality assessment for Shudan capsules.Determination of baicalin in rat plasma was applied to pharmacokinetic research with aloin as internal standard by RP-HPLC. The plasma sample was extracted with methanol.The HPLC separation was achieved on a Diamonsil C₁₈ (200 mm×4.6 mm, 5μim, Dikma) column at 35℃. The mobile phase consisted of acetonitrile-water-phosphonic acid (25:75:0.1, v/v/v) at a flow rate of 1.0 mL·min^-1. The UV detection wavelength was set at 276 nm. Linearity range was obtained in the concentration range from 0.2500 to 25.00μg·mL^-1(r≥0.995 5).The extraction recoveries exceeded 75.7 %. Intra-day RSD and inter-day RSD were both less than 6.5 %. The method is simple, special, accurate and reproducible.Baicalin showed pharmacokinetic characteristic in rat after intragastric administration of solution of Shudan capsules. After administration of solution of Shudan capsules, T_max was 4.333 h, t_1/2 was 4.527 h, C_max was 9.271μg·mL^-1, AUC was 106.910μg·h·mL^-1.