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ABSTRACT: This is a study of assessing the comparative bioavailability of roxithromycin produced by two companies in 36 healthy volunteers. On the basis of informed consent, 36 healthy male volunteers received each medicine at the roxithromycin dose of 150mg in a cross-over study. There was a 1-week washout period among the doses. Plasma concentrations of roxithromycin were monitored by an LC-MS/MS for over a period of 72 hours after administration. In this study, roxithromycin was generally well tolerated. After an oral administration of roxithromycin capsule, the pharmacokinetic parameters of roxithromycin, such as AUC(0-72 h) (66 076 microg x L x h(-1) and 70 334 microg x L x h(-1) for test and reference capsule, respectively) and AUC(0-infinity) (68 153 microg x L x h(-1) and 72 362 microg x L x h(-1)) were significantly similar. For test and reference capsule, the values of C(max) were 6 631.5 microg x L(-1) and 7 033.9 microg x L(-1) respectively, of T1/2 were 15.39 +/- 4.61 h and 16.06 +/- 5.56 h, and of T(max) were 1.3 +/- 0.9 h and 1.4 +/- 0.7 h respectively. The relative bioavailability F was 94.9% +/- 22.4% of tested formulation. The values of 90% confidence interval around the ratios (test/reference) (obtained by analysis of variance, ANOVA) were 88.3%-101.2% for C(max), 86.2%-98.9% for AUC(0-72) h, being within the predefined acceptable range for the conclusion of bioequivalence. The results of statistical analysis suggest that the two formulations be bioequivalent.
Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi 12/2009; 26(6):1315-9.
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ABSTRACT: A liquid chromatography tandem mass spectrometry (LC-MS/MS) method was developed for the simultaneous determination of the 10 major components of Da-Cheng-Qi decoction (rhein, emodin, aloe-emodin, chrysophanol, rheochrysidin, naringin, naringenin, hesperidin, magnolol and honokiol) in dog plasma. Plasma samples were spiked with internal standard (ibuprofen), acidified with HCl and extracted twice by liquid-liquid extraction using ethyl acetate. Separation was performed on a YMC-Pack ODS-A C(18) column (5 microm, 150 mm x 4.6 mm) and a C(18) guard column (5 microm, 4.0 mm x 2.0 mm) with methanol-water (92:8, v/v) at a flow rate of 0.3 mL/min. The LC/MS system was operated under the multiple reaction monitoring mode using electrospray ionization in the negative ion mode. All analytes showed good linearity over a wide concentration range (r>0.99). The linear range of the calibration curves was 5000-19.53 ng/mL for rhein; 400-3.13 ng/mL for emodin; 800-3.13 ng/mL for aloe-emodin, chrysophanol, naringin, naringenin, hesperidin, magnolol and honokiol; 160-0.63 ng/mL for rheochrysidin. The lower limit of quantification was: 19.53 ng/mL for rhein; 3.13 ng/mL for emodin, aloe-emodin, chrysophanol, naringin, naringenin, hesperidin, magnolol and honokiol; 0.6 3 ng/mL for rheochrysidin. The overall mean accuracy for the 10 major components of Da-Cheng-Qi decoction was 90.40-108.60%. Intra-day and inter-day precision was < or =12.43% and < or =11.32%, respectively. We conclude that this method is appropriate for simultaneous determination of the 10 major components of Da-Cheng-Qi decoction in dog plasma and the investigation of the pharmacokinetics of Da-Cheng-Qi decoction in dog.
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences 06/2009; 877(22):2025-31. · 2.78 Impact Factor
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ABSTRACT: To study the pharmacokinetics of acamprosate calcium (CAS 77337-73-6) in healthy Chinese subjects after oral administration of three dosage levels, 12 healthy subjects were divided into three groups and given a single oral dose of 333 or 666 or 1332 mg acamprosate calcium (enteric coated tablet). A sensitive liquid chromatography-tandem mass spectrometry method (LC-MS-MS) was used for the determination of acamprosate calcium in plasma. Both, a non-compartmental and compartmental method were used for analysis of kinetics parameters. The main pharmacokinetic parameters of the 333, 666 and 1322 mg regimen groups were as follows: tmax 7.5 +/- 2.6 h, 7.4 +/- 2.2 h, 8.1 +/- 3.1 h, Cmax 134.8 +/- 103.9 ng/mL, 297.5 +/- 188.1 ng/mL, 385.4 +/- 155.7 ng/mL, t1/2 13.3 +/- 11.4 h, 17.9 +/- 18.1 h, 15.1 +/- 9.1 h, AUC(0-t) 1772 +/- 1323 ng x h/mL, 3709 +/- 1195 ng x h/mL, 6421 +/- 2486 ng x h/mL, respectively. Statistical analysis of AUC/D showed that AUCs increased linearly with the administered dose. The kinetic process of acamprosate calcium was best fitted to a one-compartment model.
Arzneimittel-Forschung 01/2009; 59(12):631-4. · 0.72 Impact Factor
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ABSTRACT: To make better the RP-HPLC method with column-switching technique for the determination of salbutamol in human plasma.
A high-pressure flow channel selection valve and Kromasil C18 pretreatment column (20 x 4 mm, 5 microns), Ultrasphere Cyano analysis column (250 mm x 4.6 mm, 5 um, Beckman) were used. To the plasma sample 1.0 ml, 0.5 ml phosphate buffer (2.0 mol/L, pH 9.0) containing 0.4% diphenylboric acid 2-aminoethyl ester was added, then extraction was performed with the use of 4.0 ml chloroform containing 1% tetraoctylammonium bromide. The organic layer was removed and extracted again with 300 microliters (0.08 mol/L) acetic acid. 100 microliters of the acid layer was injected onto the column. The mobile phase of pH 2.8, 0.025 mol/L phosphate buffer-acetonitrile-methanol (95:4:1) was pumped at the rate of 0.9 and 1.0 ml.min-1 through the pretreatment and analysis column, respectively. The column-switching time was from 0.7 min to 1.5 min. The detector at 0.002 aufs was set at 224 nm.
The retention time for salbutamol was 6.7 min and that for internal standard (morphine) 7.6 min. The standard curve was linear over the concentration range from 0.5 to 32 micrograms/L. The lowest concentration of detection in plasma was 0.5 microgram/L. The method recovery was 96%-107%; the intra-day RSD less than 5%; the inter-day RSD less than 8%.
This method was found to be simple, rapid, sensitive and accurate for determination of salbutamol in human plasma.
Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition 08/2003; 34(3):576-9.
