ผลของยาอีฟาวิเร็นซ์ต่อเภสัชจลนศาสตร์ของยาคีโตนาโซลในผู้ป่วยติดเชื้อเอชไอวี

200

ผลของอีฟาวิเร็นว์ต่อเภสัชจลศาสตร์ของคีโตโคนาโชลในผู้ป่วยติดเชื้อเอชไอวี

Thesis (M.Sc., Pharmacology)--Prince of Songkla University, 200

ผลของคีโตโคนาโซลต่อเภสัชจลนศาสตร์ของริสเพอริโดนในอาสาสมัครชายไทยสุขภาพปกติ : รายงานผลการวิจัยฉบับสมบูรณ์

Prince of Songkla Universit

Bioequivalence study of a generic Risperidone (Iperdal®) in healthy Thai male volunteers

The objective of this study was to compare the rate and extent of absorption of a generic risperidone (Iperdal®) with a reference formulation (Risperdal®) when given orally. The study was an open label, randomized, two-period, two-sequence,single dose cross-over design with a 2 weeks washout period in 16 healthy Thai male volunteers. Single oral dose of two 2-mg tablets of risperidone were administered and serial blood samples were collected from the antecubital vein before and at0.17, 0.33, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 and 48 hours post dose. Risperidone plasma concentrations were assayed using a validated High Performance Liquid Chromatographic (HPLC)-UV method modified from Avenosoet al. (2000). Pharamcokinetic parameters i.e. Cmax, AUC0à48 and Tmax were analyzed by noncompartment analysis. Variations of the data were analyzed by Two Way Analysis of Variance (ANOVA). Statistics were tested as stated in USP 28 guidelinefor bioequivalence study. The maximum concentration (Cmax, ng/ml) of risperidone for the innovator and the generic product were 31.11±17.24 (range 5.64-56.78) and 32.58±19.77 (range 5.29-84.56) ng/ml, respectively. The area under theplasma concentration-time curve (AUC0®48) of the innovator and the generic product were 160.64±152.89 (range 18.57- 550.32) and 144.03±127.37 (range 16.27-456.0) ng.hr/ml, respectively. The time to maximum concentration (Tmax) of theinnovator and the generic product were 0.97±0.41(range 0.5-2) and 1.02±0.32 (range 0.5-1.5) hr, respectively. The 90% confidence interval of the ratio of the ln-transformed of Cmax and AUC0à48 of both preparations were 89.39-112.99% and80.02-107.28% respectively which were within the acceptance range of 80.00-125.00%. Therefore, it can be concluded that both preparations used in this study are bioequivalent in terms of both the rate and extent of absorption

Seasonal and Geographic Variation in Alkaloid Content of Kratom (<i>Mitragyna speciosa</i> (Korth.) Havil.) from Thailand

The objective of this study was to obtain data on the distribution of alkaloids in kratom plants grown in Thailand. Two collections were performed, covering the southern, central, and northern regions of Thailand and different seasons. The contents of alkaloids, including mitragynine (MG), paynantheine (PAY), and speciogynine (SG), were determined using the validated HPLC method. The 134 samples in the first collection were collected from Nam Phu subdistrict, Ban Na San, Surat Thani, Thailand, during June and October 2019 and January 2020. The maximum mitragynine content was 4.94% w/w in June (late summer), and the minimum content was 0.74% w/w in October (rainy season). To expand the study area after kratom decriminalization, 611 samples were collected in June–August 2021, October–December 2021, and January–April 2022. The accumulation of MG ranged from 0.35 to 3.46% w/w, 0.31 to 2.54% w/w, and 0.48 to 2.81% w/w, respectively. The meteorological data supported the climate’s effect on alkaloid production. Soil analysis revealed the importance of Ca and Mg in promoting alkaloid production. Geographical locations played a role in the variation of MG in kratom leaves, but did not affect the color of leaf veins. In conclusion, the present study suggested that the alkaloid content in kratom diverges based on seasonal and geographical origin