Résumé
Objective To observe the efficacy and adverse reaction of the test drug hepatitis B immunoglobin on the post market.Method Employed by the methods of multiple center's clinical trials and using the recommended dosage of hepatitis B immunoglobulin for intravenous administration,the clinical efficacy of either prevention or treatment for hepatitis B recurrence and drug related adverse reactions were observed.This consisted of 22.1 months,13 hospitals,and 525 patients with hepatitis B related liver transplantation.Result The results showed a contrasting probability of adverse reactions for different doses among the observation period.Within 6 months postoperatively with a greater or equal to recommended drug dose,the infection rate was less than 4％.In contrast,the infection rate was greater than 12％ in the group with less than the recommended drug dose.Conclusion There was an obvious dose effect relationship,and the drug safety and recommended treatment rationality were verified.
Résumé
A fast,simple and sensitive high performance liquid chromatographic (HPLC) method has been developed for determination of 10α-methoxy-6-methyl ergoline-8β-methanol (MDL,a main metabolite of nicergoline) in human plasma.One-step liquid-liquid extraction (LLE) with diethyl ether was employed as the sample preparation method.Tizanidine hydrochloride was selected as the internal standard (IS).Analysis was carried out on a Diamonsil ODS column (150 mm × 4.6 mm,5 μm) using acetonitrile-ammonium acetate (0.1 mol/L) (15/85,v/v) as mobile phase at detection wavelength of 224 nm.The calibration curves were linear over the range of 2.288-73.2 ng/mL with a lower limit of quantitation (LLOQ) of 2.288 ng/mL.The intra- and inter-day precision values were below 13％ and the recoveries were from 74.47％ to 83.20％ at three qtality control levels.The method herein described was successfully applied in a randomized crossover bioequivalence study of two different nicergoline preparations after administration of 30 mg in 20 healthy volunteers.
Résumé
A high performance liquid chromatographic method was developed and validated for the quantitative determination of catechin in rat plasma and its pharmacokinetic study after intragastric administration of Catechu and Xiongdanjiangre Wan into SD rats. Plasma samples were prepared by protein precipitation using methanol- 5％ aqueous zinc sulfate (70:30, v/v) as precipitant. Chromatographic separation was achieved on Hypersil C18 column (250 mm × 4.6 mm, 10 μm) with acetonitrile water triethylamine (6:94:0.3, v/v/v, pH 4.0±0.1, adjusted with phosphoric acid) as mobile phase, followed by a UV detection at 207 nm. Good linearity was obtained over the range of 0.143-7.15 mg/L of catechin, with correlation coefficient of 0.9992.The method was simple, sensitive, accurate and reproducible and has been successfully applied to the pharmacokinetic study of catechin in rat plasma.
Résumé
Objective To establish an RP-HPLC method for the determination of β-Sitosterol in Elaeagnus Gonyanthes Benth. Methods The separation was performed on a luna C8 (2) (150 mm×4.6 mm, 5μm) column with the mobile phase of methanol-water (88∶12, v/v) at a flow rate of 1.0 mL/min, the detection wavelength was set at 210 nm, and the temperature of the column was maintained at 35 ℃. Results The calibration curve of β-Sitosterol was linear over the concentration range of 0.075-0.375 mg/mL (r=0.9999) and the average recovery of β-Sitosterol was 96.30% with RSD of 3.60%(n=3). Conclusion The method is simple, rapid, and accurate, and can be used for the quality control of Elaeagnus Gonyanthes Benth.