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Bioequivalence of SCD Zaltoprofen Tablet to Soleton® Tablet (Zaltoprofen 80 mg) (솔레톤 정(잘토프로펜 80 mg)에 대한 삼천당잘토프로펜 정의 생물학적동등성)

  • Kang, Hyun-Ah;Park, Sun-Ae;Kim, Dong-Ho;Kim, Hwan-Ho;Yun, Hwa;Kim, Kyng-Ran;Yoo, Hee-Doo;Park, Eun-Ja;Cho, Hye-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.36 no.3
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    • pp.209-215
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    • 2006
  • Zaltoprofen, (2-(10,11-dihydro-10-oxodibenzo[b,f]thiepin-2-yl)propionic acid) is an NSAID with powerful anti-inflammatory effects as well as an analgesic action on inflammatory pain. The purpose of the present study was to evaluate the bioequivalence of two zaltoprofen tablets, $Soleton^{\circledR}$ (CJ Corp.) and SCD Zaltoprofen (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of zaltoprofen from the two zatoprofen formulations in vitro was tested using KP Vlll Apparatus ll method with various dissolution media. Twenty six healthy male subjects, $23.2{\pm}2.26$ years in age and$64.7{\pm}8.08$ 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 80 mg as zaltoprofen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of zaltoprofen in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. 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, $Soleton^{\circledR}$ were 6.33, 5.91 and 17.7% for $AUC_t$, $C_{max}$ and untransformed $T_{max}$, 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 $1.01{\sim}1og\;1.11$ and log $0.928{\sim}1og\;1.18$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating SCD Zaltoprofen tablet was bioequivalent to $Soleton^{\circledR}$ tablet.

Soil Salinity and Salt Spray Drift Tolerance of Native Trees on the Coastal Windbreaks in the South-Sea, Korea (한국 남해안방풍림 자생수종의 내염성 및 내조성 수종 선발)

  • Kim, Do-Gyun
    • Korean Journal of Environment and Ecology
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    • v.24 no.1
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    • pp.14-25
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    • 2010
  • This study was carried out to investigate the soil salinity and salt spray drift of the indigenous windbreak trees, and its main purpose was to provide basic data for the selection of salt-tolerant trees in the saline coastal region in the South Sea of Korea. The soil salinity($EC_{1:5}$)was $0.18dSm^{-1}$, which was an average degree of the whole areas of investigation whose salinity degree ranged from $0.05dSm^{-1}$ to $0.58dSm^{-1}$. The level of soil salinity gradually decreased as it moved farther inland, except the belt I. The level of decreasing soil salinity was found to be in the following order: belt II, belt III, belt I, belt IV. The degree of soil salinity was $EC_{1:5}$ $0.22dSm_{1:5}$, $0.22dSm_{1:5}$ $0.19dSm^{-1}$ and $0.13dSm^{-1}$ respectively. The total 110 taxa, which consisted of 45 families, 74 genus, 101 species, and 9 varieties, were found to be tolerant to both soil salinity and salt spray drift. The trees that grow in the highest degree of salinity($EC_{1:5}$ $0.50dSm^{-1}$)were Parthenocissus tricuspidata(Siebold & Zucc.), Planch and Lonicera japonica Thunb. The next group of trees that grow in the high degree of salinity ranging from $EC_{1:5}$ 0.41 to $0.50dSm^{-1}$ was Cudrania tricuspidata(Carr.) Bureau ex Lavall$\acute{e}$e, Rubus parvifolius L., Zanthoxylum schinifolium(Siebold & Zucc.), Hedera rhombea(Miq.) Bean., Robinia pseudoacacia L., Quercus serrata Thunb., Callicarpa dichotoma(Lour.) K. Koch, and so on. The woody species which grew in the entire belts were Pueraria lobata(Willd.) Ohwi and Vitis flexuosa Thunb., and Vitex rotundifolia L. f. which was known to be highly tolerant to salt spray drift was found only in belt I. The woody species with high important value(IV) were Zelkova serrata(Thunb.) Makino., Celtis sinensis Pers., Koelreuteria paniculata Laxmann, Mallotusjaponicus(Thunb.) Muell. Arg., Trachelospermum asiaticum(Siebold & Zucc.) NAKAI, and Pueraria lobata(Willd.) Ohwi. These species were classified as native windbreak trees that are comparatively more tolerant to salt spray drift than other kinds.

COMPARATIVE EXPERIMENTAL STUDY ON MEASUREMENT OF ORAL TEMPERATURE WITH DIFFERENT KINDS OF CLINICAL THERMOMETERS -comparison of Oral Temperature and Oral Placement Time among Fahrenheit Glass Thermometer, Electric Thermometer, Yu II centigrade Glass Thermometer, and Kuk II centigrade Glass Thermometer- (각종 체온계의 구강체온측정에 관한 실험적 비교연구 -외제화씨 체온계, 전자체온계 및 국산 섭씨체온계에 의한 측정온도와 측정시간의 비교-)

  • 윤정숙
    • Journal of Korean Academy of Nursing
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    • v.4 no.2
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    • pp.93-106
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    • 1974
  • The purposes of this study are to identify the necessity of utilization of electric thermometer, to determine the difference of clinical thermometers to reach maximum or optimum temperature, and to determine the length of time necessary for temperature taking, with Fahrenheit thermometer, electric thermometer, Yu Ⅱ centigrade thermometer, and Kuk ll centigrade thermometer. The first and second comparative Experiments were' conducted from August 25 through September 30, 1973. In the first experiment, Fahrenheit thermometer, which had been accurately teated two times, and electric thermometer have been utilized. These two kinds of thermometers were inserted simultaneously under the central area of the tongue and the mouth kept closed while thermometers were in place. All temperature readings were done at one minute interval until leaching-maximum temperature. These procedures were repeated one hundred times and the data were-analyzed statistically by means of the t-test. In the second experiment, Fahrenheit thermometer, which had been accurately tested two. times, Yu Ⅱ centigrade thermometer, and Kuk Ⅱ centigrade thermometer have been utilized. These three kinds of thermometers were inserted simultaneously under the central area of the. tongue and the mouth kept closed while thermometer were in place. All temperature readings were done at one minute interval until reaching maximum temperature. These procedures were. repeated one hundred times and the data were analyzed statistically by means of the F-ratio Under the eight hypotheses designed for this study, the findings obtained are as follows: 1. There were no significant differences in the maximum temperature between Fahrenheit thermometer and electric thermometer. The mean maximum temperature for Fahrenheit thermometers was 37.06℃ and for electric thermometer was 37.09℃. 2. The placement time to reach maximum temperature taken by Fahrenheit thermometer was significantly shorter than that by electric thermometer. The mean placement time for Fahrenheit thermometers was 4.04 minutes, for electric thermometer was 5.52 minutes. In the case of Fahrenheit thermometers, 45 to 77 percent after 3 to 5 minutes, over 90 Percent after 7 minutes, and 100 percent after 10 minutes, had reached optimum temperature. When the electric thermometer was used, 23 to 54 percent after 3 to 5 minutes, over 90 percent after 9 minutes, and 100 percent after 12 minutes, had reached optimum temperature. 5. There ware no significant differences in the maximum temperature among Fahrenheit thermometer, Yu Ⅱ centigrade thermometer, and Kuk Ⅱ centigrade thermometer. The mean maximum temperature for Fahrenheit thermometers was 36.67℃, for Yu Ⅱ centigrade thermometer, was 33.73℃, and for Kuk Ⅱ centigrade thermometers was 37.76℃. 6. There were no significant differences in placement time to reach maximum temperature among Fahrenheit thermometer, Yu Ⅱ centigrade Thermometer, and Kuk Ⅱ centigrade thermometer. The mean placement time (or Fahrenheit thermometers was 7.77 minutes, for Yu Ⅱ centigrade thermometers was 7.25 minutes, and Kuk Ⅱ centigrade thermometers was 7.25 minutes. In the case of Fahrenheit thermometers, 8 to 24 percent after 3 to 5 minutes, over 90 percent after 11 minutes, and 100 percent after 13 minutes, had reached maximum temperature. When the Yu Ⅱ centigrade thermometer was used, 10 to 27 percent after 3 to 5 minutes, over 90 percent after 11 minutes, an8 103 percent after 13 minutes, had reached maximum temperature. When the Kuk Ⅱ centigrade thermometer was used, 11 to 27 Percent after 3 to 5 minutes, over 90 percent after 11 minutes, and 100 percent after 12 minutes, had reached maximum temperature. 7. There were no significant differences in the optimum temperature(the maximum temperature minus 0.1℃) among fahrenheit thermometer, Yu Ⅱcentigrade thermometer, and Kuk Ⅱ centigrade thermometer. The mean optimum temperature for Fahrenheit thermometers was 36.60℃, for Yu Ⅱ centigrade thermometers was 36.69℃, and Kuk Ⅱ centigrade thermometers was 36.69℃. 8. There were no significant differences in placement time to reach optimum temperature among Fahrenheit thermometer, Yu Ⅱ centigrade thermometer, and Kuk Ⅱ centigrade thermometer The mean placement time for Fahrenheit thermometers was 5.70 minutes, for Yu Ⅱ centigrade thermometers was 5.54 minutes, and for Kuk Ⅱ centigrade thermometers was 5.28 minutes. In the case of Fahrenheit thermometers, 21 to 49 percent after 3 to 5 minutes, over 90 percent after 9 minutes, and 100 percent after 12 minutes, had reached optimum temperature. When the Yu Ⅱ centigrade thermometer was used, 23 to 51 percent after 3 to 5 minutes over 90 percent after 10 minutes, and 100 percent after 12 minutes, had reached optimum temperature. When the Kuk Ⅱ centigrade Thermometer was used, 23 to 57 Percent after 3 to 5 minutes, over 90 percent after 9 minutes, and 100 Precent after 11 minutes, had reached optimum temperature.

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