• Title/Summary/Keyword: no reference

Search Result 2,206, Processing Time 0.031 seconds

Bioequivalence Evaluation of Two Brands of Zolpidem Tartrate 10 mg Tablets(Zanilo and Stilnox) in Healthy Male Volunteers

  • Ryu, Ju-Hee;Lee, Heon-Woo;Lee, Hyun-Su;Kang, Il-Mo;Seo, Ji-Hyung;Kang, Jin-Yang;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
    • /
    • v.36 no.5
    • /
    • pp.343-348
    • /
    • 2006
  • The purpose of the present study was to evaluate the bioequivalence of two zolpidem tartrate tablets, Stilnox tablet(Sanofi-aventis Korea, reference product) and Zanilo tablet(ChoDang Pharm Co., Ltd., Korea, test product), according to the guidelines of Korea Food and Drug Administration(KFDA). After adding an internal standard(cimetropium), 250 ${\mu}L$ plasma samples were extracted using 1.3 mL of ethyl acetate. Extracted compounds were analyzed by HPLC with triple-quadrupole mass spectrometry. This method for determination of zolpidem is proved accurate and reproducible with the limit of quantitation of 1 ng/mL in human plasma. Twenty-four healthy male Korean volunteers received each medicine at the zolpidem tartrate dose of 10 mg in a $2{\times}2$ crossover study. There was one-week washout period between the doses. Plasma concentrations of zolpidem were monitored for over a period of 8 hr after the administration. $AUC_{0-t}$(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 $AUC_{0-t}$ and $C_{max}$. No significant sequence effect was found for all of the bio-availability 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 0.92-log 1.06 for $AUC_{0-t}$, log 0.96-log 1.13 for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that Zanilo tablet is bioequivalent to Stilnox tablet.

The Analysis of Perchlorate in Nakdong River and Tap Water (낙동강 수계 및 수돗물에서의 Perchlorate($ClO_4^-$) 분석)

  • Kim, Hwa-Bin;Oh, Jeong-Eun;Lee, Sung-Yun;Cho, Jae-Weon;Snyder, Shane
    • Journal of Korean Society of Environmental Engineers
    • /
    • v.28 no.7
    • /
    • pp.776-781
    • /
    • 2006
  • Perchlorate ion($ClO_4^-$), which is present in the solid propellant for rocket, herbicide and some fertilizers. Perchlorate inhibits iodide uptake by the human thyroid gland. Impairment of thyroid function in expectant mothers may impact the fetus and result in effects including cerebral palsy, give rise to thyroid gland cancer. The US EPA(Environmental Protection Agency) adopted a reference dose(RfD) for perchlorate 0.0007 mg/kg-day, and this guidance lead to a Drinking Water Equivalent Level(DWEL) of 24.5 ${\mu}g/L$. The studies about perchlorate are actively performed in foreign countries, especially in USA but there is no study which surveyed the perchlorate contamination in Korea. Therefore, this study was done to investigate perchlorate contamination in Nak-dong river and tap water. The perchlorate was detected in Nakdong river and ranged from ND to 278.4 ${\mu}g/L$. The highest concentration was observed in Kumichon. The perchlorate concentration was decreased with the down stream of Nakdong river. The perchlorate concentration in tap water was varied with the cities and the concentration levels were $ND{\sim}34.1$ ppb. The highest perchlorate concentration was observed in DalsuGoo in Daegu and the similar concentration($9{\sim}11$ ${\mu}g/L$) was detected in most of the districts in Busan. The result of this study suggests that there is a perchlorate source near the Nakdong river and the urgent policy is needed to control perchlorate for the cities which are supplied from Nakdong river as for their tap water.

Effects of Mutation at Two Conserved Aspartate Residues and a Serine Residue on Functions of Yeast TSA 1 (Saccharomyces cerevisiae TSA1의 보존된 아스파트산 잔기 및 세린 잔기의 변이가 과산화효소 활성 및 샤페론 활성에 미치는 영향)

  • Lee, Songmi;Cho, Eun Yi;Kim, Kanghwa
    • Microbiology and Biotechnology Letters
    • /
    • v.45 no.1
    • /
    • pp.81-86
    • /
    • 2017
  • Alignment of 967 reference sequences of the typical 2-Cys peroxiredoxin family of proteins revealed that 10 amino acids were conserved, with over 99% identity. To investigate whether the conserved aspartic acid residues and serine residue affect the peroxidase and chaperone activity of the protein, we prepared yeast TSA1 mutant proteins in which aspartic acids at positions 75 and 103 were replaced by valine or asparagine, and serine at position 73 was replaced by alanine. By non-reducing SDS-PAGE, TSA1 and the S73A, D75V and D75N mutants were detected in dimeric form, whereas the D103V and D103N mutants were detected in various forms, ranging from high molecular-weight to monomeric. Compared with wild type TSA1, the D75N mutant exhibited 50% thioredoxin peroxidase activity, and the S73A and D75V mutants showed 25% activity. However, the D103V and D103N mutants showed no peroxidase activity. All proteins, except for the D103V and D103N mutants, exhibited chaperone activity at $43^{\circ}C$. Our results suggest that the two conserved aspartic acid residues and serine residue of TSA1 play important roles in its thioredoxin peroxidase activity, and D103 plays a critical role in its chaperone activity.

ESTIMATION OF RELATION BETWEEN TECHNIQUES OF DYE PENETRATION FOR MICROLEA-KAGE AND SEM EVALUATION FOR MARGINAL ADAPTATION OF THE RESTORATION (수복물의 미세누출도와 변연적합도 측정에 사용되는 방법 사이의 상관 관계 평가)

  • Hwang, Soon-Joo;Shin, Dong-Hoon
    • Restorative Dentistry and Endodontics
    • /
    • v.31 no.5
    • /
    • pp.337-343
    • /
    • 2006
  • The purpose of this study was to estimate the relation between techniques used for microleakage from dye penetration and for marginal adaptation from SEM evaluation of the restoration. Using high speed #330 bur class V cavities ($4{\times}3{\times}1.5 mm$ around CEJ) were prepared on the buccal surface of 20 extracted human molars. Six dimples as reference points for SEM and dye penetration evaluation were made with 1/2 round bur. Cavity was bulk filled with microhybrid composite resin (Esthet X) and all-in-one adhesive (Xeno III). Teeth were stored in saline solution for one day, after then, they were finished and polished using Sof-Lex system. Fifty percent silver nitrate dye solution was used for the evaluation of microleakage and resin replica was used for marginal adaptation. All of these were done after 1000 times thermocycling between 5 and $55^{\circ}C$. Vertical sections were made through three dimples of restoration to obtain samples for the evaluation of dye penetration and inner marginal adaptation. Outer adaptational estimation was done with an intact restoration before sectioning. Dye penetration was determined in three degrees and percentage of outer and inner leaky margin was estimated from SEM image The data were analysed statistically: Spearman's rho test were used to check relationships between two methods. The result were as follows : 1. There were significant relationships between degree of dye penetration and inner and outer marginal adaptations each (p < 0.01). 2. However, there was no significant relationship between the results or inner and outer marginal adaptation. Within the results of this study, relationship between the percentage of marginal adaptation and microleakage shows significant relationship. However, inner and outer marginal adaptation did not show any significant relationship mutually.

Evaluation of the Forest Bird Community in the Breeding Season by using the Sound Recording System (산림성 조류의 번식기 음성녹음을 이용한 조류군집 평가)

  • Yoo, Seung-Hwa;Han, Hyun-Jin;Kim, Dong-Won;Joo, Woo-Young
    • Korean Journal of Environment and Ecology
    • /
    • v.32 no.1
    • /
    • pp.39-46
    • /
    • 2018
  • Breeding bird surveys provide the reference information for understanding bird community structure and function in the ecosystem and conserving biodiversity. Recent rapid change of biodiversity due to climate change and other factors has made it necessary to utilize acoustic sensors for accuracy and spatial expansion of forest bird survey data and for time-series monitoring of forest birds. The objective of this study is to investigate the possibility of using acoustic recording sensor to evaluate the diversity of forest birds at breeding season by comparing and analyzing the recorded data of bird songs and field bird survey data. We conducted the site survey and recording in 186 points in 48 areas of 4 regions of Gombaeryeong and Jochimryeong around Jeombongsan Mountain and Jugryeong and Gochiryeong around Sobaeksan Mountain from May 2nd to 16th in 2013. The analysis of the correlation between the recording result and Bird Community Index based on the field survey showed that the number of bird species, population, and the number of bird songs by recording was significantly correlated to the number of species and population by field survey. Moreover, the number of bird species and the number of bird songs by recording showed a significant correlation to species diversity and species richness but no or low significant correlation to species evenness by the field study (observation and listing in parallel). As a result, it was possible to check species composition and species diversity of bird communities by analyzing acoustic recording data on the field. The acoustic recordings of bird songs in the breeding period were more reliable than the non-breeding period in the correlation of recording result and species diversity and for utilization.

A Study on the Diet Items of American Bullfrog (Lithobates catesbeianus) in Ga-hang Wetland, Korea (가항늪에 서식하는 황소개구리(Lithobates catesbeianus)의 먹이원 분석 연구)

  • Park, Chang-Deuk;Lee, Chang-Woo;Lim, Jeong-Cheol;Yang, Byeong-Gug;Lee, Jeong-Hyun
    • Korean Journal of Environment and Ecology
    • /
    • v.32 no.1
    • /
    • pp.55-65
    • /
    • 2018
  • This study was conducted to clarify diet items and predatory behavior of American bullfrog (Lithobates catesbeianus) according to the sex, maturity and season from April to September 2014 at Gahang wetland of Changnyeong-gun, Gyeongsangnamdo province, Korea. We examined the stomach contents of L. catesbeianus using a gastrectomy technique and identified the contents to a genus or species. The examination showed that large and heavy individual of L. catesbeianus fed on larger amounts of food. However, there were no statistically significant differences in predation amount according to the sex and maturity of L. catesbeianus. The main diet item of during the study period was mostly Insecta (average population rate of 65.5%), followed by Crustacea (13.5%) and Gastropoda (7.9%). The most preferred diet item of L. catesbeianus was Muljarus japonicus. Surprisingly, L. catesbeianus also foraged Parus major, Apodemus agrarius, and Crocidura lasiura. Ths findings showed that L. catesbeianus directly disturbed the wetland ecosystem. We expect the results will be the important reference data for checking the impact of L. catesbeianus, which is designated as invasive species by the Ministry of Environment, on wetland ecosystem.

Preference and Competition for Shelters at Day and Night between Adult and Juvenile Schlegel's Japanese Gecko (Gekko japonicus) in an Indoor Vivarium (실내 사육장에서 도마뱀부치(Gekkojaponicus) 성체와 유체의 주야간 은신처 선호와 경쟁)

  • Park, Il-Kook;Kim, Dae-In;Jang, Se-Yoon;Kim, Do-Yeon;Choi, Woo-Jin;Kim, Jong-Sun;Koo, Kyo-Soung;Park, Daesik
    • Korean Journal of Environment and Ecology
    • /
    • v.32 no.4
    • /
    • pp.373-380
    • /
    • 2018
  • We examined activities of adult (n=9, 3 females and 6 males) and juvenile (n=4) Schlegel's Japanese gecko (Gekko japonicus) in an indoor vivarium for 47 days to study the preference and competition for shelters at day and night. The result showed the strong correlation between the temperature inside the shelter and the body temperature of Schlegel's Japanese gecko and more individuals observed outside the shelters at nighttime than daytime. Both adults and juveniles showed a preference for certain shelters. The adults preferred the warmer shelters in the daytime while the juveniles preferred the same shelter in both daytime and nighttime. Both adults and juveniles observed outside the shelter at the nighttime had higher body temperature than those found inside. In the daytime, the body temperature of adults was higher than that of juveniles, but there was no significant difference in the nighttime. The results imply that G. japonicus, which is the nocturnal lizard, prefers the shelters with higher temperature and that there is the competition for shelters between adults and juveniles. This study provides the reference data on the relationships between the body temperature and the activities of G. japonicus.

Analysis for the Regional Characteristic of Climatic Aridity Condition in May (5월 기후 건조현상의 지역별 특성 분석)

  • Rim, Chang-Soo;Kim, Seong-Yeop
    • Journal of Korea Water Resources Association
    • /
    • v.46 no.6
    • /
    • pp.613-627
    • /
    • 2013
  • In this study, to understand the May aridity condition of each region for the year of the worst drought on record in each duration (1-, 3-, 6-, 12-, 24 months), monthly climate data recorded from 1973 to 2006 at 53 climatological stations in South Korea were used to estimate the FAO Penman-Monteith reference potential evapotranspiration (RET). Monthly precipitation and RET were used to estimate P/RET as aridity index and variation index (VI) of P/RET, and these indexes are compared with SPI (Standard Precipitation Index). Fifty three climatological stations were grouped into 20 regions, so that May aridity conditions of 20 regions were studied. Furthermore, regional trend of May aridity index was studied by applying Mann-Kendall trend analysis, Spearman rank test, and Sen's slope estimator. The study results show that variation index (VI) of P/RET and SPI have close correlation. Throughout the country, as the duration is shorter, May aridity was more severe. In case of 3-month and 6-month duration, most of region show significant or non-significant decreasing trend of aridity index. However, no region show significant decreasing trend of aridity index in case of 12-month and 24-month duration.

Bioequivalence Test of Rebamipide 100 mg Tablets (레바미피드 100 mg 정제의 새울학적동등성)

  • Kim, Se-Mi;Cho, Hea-Young;Kang, Hyun-Ah;Lee, Yong-Bok
    • Korean Journal of Clinical Pharmacy
    • /
    • v.18 no.1
    • /
    • pp.38-44
    • /
    • 2008
  • Rebamipide, ($\pm$)-2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-yl] propionic acid, is used for mucosal protection, healing of gastroduodenal ulcers, and treatment of gastritis. It works by enhancing mucosal defense, scavenging free radicals and temporarily activating genes encoding cyclooxygenase-2. The purpose of the present study was to evaluate the bioequivalence of two rebamipide tablets, $Mucosta^{(R)}$ (Korea Otsuca Pharmaceuticals Co., Ltd.) and Mustar (Korean Drug Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of rebamipide from the two rebamipide formulations in vitro was tested using KP VIII Apparatus II method with pH 6.8 dissolution medium. Twenty six healthy male subjects, $23.46{\pm}2.63$ years in age and $66.62{\pm}8.97\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 100 mg as rebamipide was orally administered, blood samples were taken at predetermined time intervals and the concentrations of rebamipide in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution medium. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Mucosta^{(R)}$ were -5.08, 3.52 and -9.71 % for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.84$\sim$log 1.07 and log 0.90$\sim$log 1.17 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Mustar tablet was bioequivalent to $Mucosta^{(R)}$ tablet.

  • PDF

A Study on Property with Ratio of Water Mixture in Hydroponic Polyurethane Waterproofing Materials (수경화성 폴리우레탄 도막 방수재의 물 혼합비에 따른 물성변화연구)

  • Park, Jin-Sang;Park, Wan-Goo;Kim, Dong-Bum;Lee, Min-Kyu;Oh, Sang-Keun
    • Journal of the Korean Recycled Construction Resources Institute
    • /
    • v.3 no.4
    • /
    • pp.348-354
    • /
    • 2015
  • Urethane waterproofing materials which currently being used most commonly in the Korean domestic market have high applicability and construct layers without forming any joints, but under the influence of low temperature and low humidity, as well as the thickness of the applied layer, the curing time of this material may become extended in construction sites. To resolve these issues, a proposed method of using water-hardening type of polyurethane waterproofing materials are being developed. However, there currently lacks any standards or evaluation methods on determining an optimal mixture ratio of water for the water-hardening polyurethane waterproofing materials. Therefore, workers and construction workers are relying on their hands-on-skills and experience to determine this ratio and are not able to obtain a consistent performance quality out of these materials. Therefore, for the establishment of a board applicability of the water-hardening polyurethane waterproofing methods in construction sites, this study objectively analyzes the changes in the performance of these materials depending on the changes of the water mixture ratio and attempts to procure the optimal ratio on the basis of forming a provisionary standard. The study prepares mixtures of varying ratio(no water added, 5, 10, 15, 20, 25, 30, 40 and 50) and conducts comparative analysis respective mixtures' performances and their changes in the physical properties in an objective manner and proposes a provisional optimal value that can serve as a data base that can be used as a reference for future studies.