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타리비드 정(오플록사신 100㎎)에 대한 파비드 정의 생물학적동등성
박완수,조성희,이헌우,임호택,홍성제,서성훈,류재환,이경태 한국약제학회 2005 Journal of Pharmaceutical Investigation Vol.35 No.1
The purpose of the present study was designed to evaluate the bioequivalence of two ofloxacin tablets, Tarivid (Jell Pharm. Co., Ltd.) and Favid (ILHWA Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, 23.67±3.12 year in age and 68.50±7.23 kg in body weight, were divided into two groups and a randomized 2x2 cross-over study was employed. After four tablets containing 100 mg of ofloxacin were orally administered, blood was taken at predetermined time intervals and concentrations of ofloxacin in plasma were deter mined using HPLC. Pharmacokinetic parameters such as AUC_(t) and T_(max) were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUC_(t), and C_(max) and untransformed T_(max). There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log 0.8 to log 1.25 (e.g., log 0.94-log 1.04 and log 0.90-log 1.07 for AUC_(t) and C_(max) respectively). The major parameters. AUC_(t) and C_(max) met the criteria of KDFA for bioequivalence indicating that Favid tablet is bioequivalent to Tarivid tablet.
Im, Wan-Taek,Hu, Zi-Ye,Kim, Kyoung-Ho,Rhee, Sung-Keun,Meng, Han,Lee, Sung-Taik,Quan, Zhe-Xue N.V. Swets en Zeitlinger 2012 Antonie van Leeuwenhoek Vol.102 No.2
<P>Strain Gsoil 348(T) was isolated from a ginseng field soil sample by selecting micro-colonies from one-fifth strength modified R2A agar medium after a long incubation period. 16S rRNA gene sequence analysis indicated that the strain is related to members of the phylum Armatimonadetes (formerly called candidate phylum OP10). Strain Gsoil 348(T) is mesophilic, strictly aerobic, non-motile and rod-shaped. It only grows in low nutrient media. The major respiratory quinones are menaquinones MK-11 and MK-10, and the main fatty acids are iso-C(15:0), iso-C(17:0), C(16:0) and C(16:1) ω11c. The G+C content is 61.4 mol%. The 16S rRNA gene sequences in public databases belonging to the phylum Armatimonadetes were clustered here into 6 groups. Five of these groups constituted a coherent cluster distinct from the sequences of other phyla in phylogenetic trees that were constructed using multiple-outgroup sequences from 49 different phyla. On the basis of polyphasic taxonomic analyses, it is proposed that strain Gsoil 348(T) (= KACC 14959(T) = JCM 17079(T)) should be placed in Fimbriimonas ginsengisoli gen. nov., sp. nov., as the cultured representative of the Fimbriimonadia class. nov., corresponding with Group 4 of the phylum Armatimonadetes.</P>
Im, Ho-Taek,Won, Jong-Hoen,Cho, Sung-Hee,Lee, Heon-Woo,Park, Wan-Su,Rew, Jae-Hwan,Lee, Kyung-Tae The Korean Society of Pharmaceutical Sciences and 2005 Journal of Pharmaceutical Investigation Vol.35 No.5
The purpose of the present study was to evaluate the bioequivalence of two cetirizine HCl tablets, Zyrtec tablet (UCB Pharm. Co., Ltd. Korea, reference product) and Zyrix tablet (Kukje Pharm. Co., Ltd., Korea, test product), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (diazepam), plasma samples were extracted using 1 mL of dichloromethane. Compounds extracted were analyzed by reverse-phase HPLC with ultra-violet detector. This method for determination cetirizine is proved accurate and reproducible with a limit of quantitation of 10 ng/mL in male plasma. Twenty-four healthy male Korean volunteers received each medicine at the cetirizine HCl dose of 10 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of cetirizine were monitored for over a period of 24 hr after the administration. AUC (the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUC and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals for the log transformed data were acceptable range of log 0.8 to log 1.25 $(e.g.,\;log\;0.93-log\;1.08\;for\;AUC_{0-t},\;log\;0.91-log\;1.08\;for\;AUC_{0-{\infty}}\;and\;log\;1.01-log\;1.11\;for\;C_{max})$. The major parameters, AUC and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that Zyrix tablet is bioequivalent to Zyrtec tablet.
김인협,Wan-Taek Im,Kiseong Joh,김명겸,Jung-Hoon Yoon,Won Yong Kim,서태건 국립생물자원관 2023 Journal of species research Vol.12 No.3
We isolated and identified 25 unrecorded bacterial species belonging to the phylum Actinomycetota found in the Republic of Korea. Sequence comparison of 16S rRNA was performed using the NCBI BLAST and EzBioCloud database to identify 25 species, which had a 16S rRNA gene sequence similarity of >98.8% and were allocated as unrecorded species in the Republic of Korea. Among the 25 unrecorded bacterial strains, Streptomyces was the most common with nine species, followed by Leifsonia with two species. Isoptericola, Nocardioides, Dermacoccus, Sinomonas, Patulibacter, Marmoricola, Allobranchiibius, Aldersonia, Actinokineospora, Agromyces, Aeromicrobium, Cellulomonas, and Gordonia with one species each were also found. Twenty-five unrecorded species were excavated in various environments, such as tidal flats, ferns, soil, pine cones, moss, mud, wetlands, and plants. These isolates were characterized on the basis of their phylogenetic, biochemical properties, and morphological data, and species descriptions were provided.
Lactobacillus siliginis sp. nov., isolated from wheat sourdough in South Korea.
Aslam, Zubair,Im, Wan-Taek,Ten, Leonid N,Lee, Myung-Jin,Kim, Kyoung-Ho,Lee, Sung-Taik Society for General Microbiology 2006 International journal of systematic and evolutiona Vol.56 No.9
<P>The taxonomic position of two lactic-acid-producing bacterial strains, isolated from wheat sourdough in South Korea, was studied using a polyphasic approach. Phylogenetic analysis on the basis of 16S rRNA gene sequences and biochemical and physiological characteristics indicated these two strains to be members of the genus Lactobacillus. They had high 16S rRNA gene sequence similarity (98.5 %) with Lactobacillus rossiae DSM 15814(T) and very low (<94.0 %) similarity with any other recognized species of the genus Lactobacillus. These two strains (designated M1-212(T) and M2-236) were heterofermentative, facultatively anaerobic, Gram-positive, non-spore-forming, non-motile, short rod-shaped bacteria. The optimum growth temperature for these strains was 30 degrees C (no growth at 15 or 45 degrees C) and they were able to tolerate 5 % (w/v) NaCl. The G+C content of the genomic DNA of the two strains was 45.5 mol%, within the range of values reported for the genus Lactobacillus (32-53 mol%). The peptidoglycan was of the A3alpha (l-lys-d-glu-l-Ala) type. Physiological, biochemical and genotypic data, as well as results of DNA-DNA hybridization of the genomic DNA with one of the closest phylogenetic relatives, L. rossiae DSM 15814(T), indicated that the strains represent a novel species of the genus Lactobacillus, for which the name Lactobacillus siliginis sp. nov. is proposed. The type strain is M1-212(T) (=KCTC 3985(T)=NBRC 101315(T)).</P>