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Bioequivalence of Broadcef Capsule to Cefradine Yuhan Capsule (Cephradine 500 mg) (유한세프라딘 캅셀(세프라딘 500 mg)에 대한 브로드세프 캅셀의 생물학적 동등성)

  • Cho, Hea-Young;Lee, Suk;Kang, Hyun-Ah;Oh, In-Joon;Lim, Dong-Koo;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.32 no.3
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    • pp.215-221
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    • 2002
  • Cephradine is a first generation cephalosporin and has broad spectrum antibacterial activity against gram-positive and gram-negative microorganisms, through inhibition of bacterial cell wall synthesis. Cephradine is useful for treatment of infections of the urinary and respiratory tract, skin and soft tissues. The purpose of the present study was to evaluate the bioequivalence of two cephradine capsules, Cefradine Yuhan (YuHan Corporation) and Broadcef (Ilsung Pharmaceuticals Co. Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The cephradine release from the two cephradine capsules in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty normal male volunteers, $23.10{\pm}2.90$ years in age and $67.69{\pm}8.04\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 500 mg as cephradine was orally administered, blood was taken at predetermined time intervals and the concentrations of cephradine in serum were determined using HPLC method with UV detector. The dissolution profiles of two cephradine capsules were very similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AVC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AVC_t\;and\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences in $AVC_t,\;C_{max}\;and\;T_{max}$ between two capsules based on the Cefradine Yuhan were -2.87%, -0.96% and -4.85%, respectively. There were no sequence effects between two capsules in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of 1og(0.8) to log(1.25) $(e.g.,\;log(0.93){\sim}log(1.02)\;and\;log(0.88){\sim}log(1.13)\;for \;AVC_t\;and\;C_{max},\;respectively)$. The 90% confidence interval using untransformed data was within ${\pm}20%$ $(e.g., \;-17.54{\sim}7.78\;for\;T_{max})$. All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Broadcef capsule is bioequivalent to Cefradine Yuhan capsule.

Bioequivalence of Hanacef Capsule to Duricef Capsule (Cefadroxil 500 mg) (듀리세프 캅셀(세파드록실 500 mg)에 대한 하나세프 캅셀의 생물학적 동등성)

  • Cho, Hea-Young;Lee, Suk;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.32 no.2
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    • pp.135-140
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    • 2002
  • Cefadroxil is a semi-synthetic cephalosporin active against many Gram-positive and Gram-negative bacteria. The drug has been used for the treatment of the urinary and respiratory tract infections when caused by susceptible strains of the designated microorganism. The purpose of the present study was to evaluate the bioequivalence of two cefadroxil capsules, Duricef (Bo Ryung Pharmaceutical Co. Ltd.) and Hanacef (Korean Pharmaceutical Co. Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The cefadroxil release from the two cefadroxil capsules in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four normal male volunteers, $21.58{\pm}2.43$ years in age and $70.74{\pm}10.29$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 500 mg as cefadroxil was orally administered, blood was taken at predetermined time intervals and the concentrations of cefadroxil in serum were determined using HPLC with UV detector. The dissolution profiles of two cefadroxil capsules were very similar at all 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 $AUC_t\;and\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two capsules based on the Duricef were 0.05%, -5.29% and 4.53%. There were no sequence effects between two capsules in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) $(e.g.,\;log(0.95){\sim}log(1.05)\;and\;log(0.87){\sim}log(1.02)$ for $AUC_t\;and\;C_{max}$, respectively). The 90% confidence interval using untransformed data was within ${pm}20%$ $(e.g.,\;-6.75{\sim}15.74\;for\;T_{max})$. All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Hanacef capsule is bioequivalent to Duricef capsule.

Encapsulation of Pine Agaric ( Tricholoma matsutake) Flavor with Alginates (알긴산을 이용한 송이 향의 캡슐화)

  • You Byeong Jin;Lim Yeong seon
    • Korean Journal of Fisheries and Aquatic Sciences
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    • v.35 no.3
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    • pp.231-236
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    • 2002
  • Encapsulating 1-octen-3-ol with alginates solution, the effects of physical properties (viscosity, emulsion activity, emulsion stability) of alginates solutin on the retention of 1-octen-3-ol in capsules were investigated. Only alginates solutions haying less than 350 cP in viscosity were capable to be adopted to spray dry. Adding citric acid to alginates solution in order to reduce its viscosity, the concentration of citric acid became higher, the viscosity of alginates solution were lower. Adding $0.1\% of citric acid could reduce viscosity of alginates solution to 150 cP. The viscosity of alginates solution after emulsifying showed higher value than that of solution before emulsifying, but its viscosity were within the possible ranges for spray drying. The lower viscosity of alginates solution were, EAI became higher but ESI and amount of remaining 1-octen-3-ol in capsules were lower, In reducing the viscosity of alginates solutions, heating time after adding citric acid were longer, the their viscosity became lower. Differences of viscosity of alginates solution after and before emulsifying were little, In encapsulating raw pine agaric with alginates solution, the adding amount of soybean oil increased, the amounts of remaining 1-octen-3-ol in capsules increased. After freeze drying the amount of remaining 1-octen-3-ol in alginates capsules prepared with raw pine agaric was higher than that after cold air flow drying.

First Sexual Maturity, Spawning Frequency and Deposition of the Egg Capsules of the Female Purple Shell Rapana venosa in the Slag Deposit Area, Gwangyang Bay, Korea (한국 광양만, 슬러그 적재장내에 서식하는 암컷 피뿔고둥 Rapana venosa의 군성숙도, 산란빈도 및 난낭 산출)

  • Chung, Ee-Yung;Kim, Si-Hwan;Seong, Chi-Nam
    • Development and Reproduction
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    • v.6 no.1
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    • pp.37-44
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    • 2002
  • First sexual maturity, sex ratio, spawning frequency, deposition of the egg capsules and fecundity of the female Rapana venosa(Valenciennes) inhabited in the artificially closed slag deposit area, Gwangyang Bay were investigated by histologicai and visual observations for natural living resource management. The rate of individuals reaching the first sexual maturity was 51.6% in females measuring 7.1~8.0 cm in shell height, and 100% in those > 10.1 cm. The total number of egg capsules per individual and the mean number of eggs in an egg capsule were 192~382 and 500, respectively. However, the number of eggs per individual and sizes of egg capsules under lower salinity and deficient food conditions in the closed slag deposit area were smaller than those under the optimum salinity and sufficient food conditions in the open regions. Fecundities of the species were approximately from 96,000 to 191,000 eggs/individual with two to low broods(spawning frequencies) during the spawning season. The duration of development in egg capsules was 18~19 days at about 18~2$0^{\circ}C$. R. venosa is a species whose embryos hatch as veliger larvae, not juvenile snail. The sex ratio of female : male was not significantly different from 1 : 1($\chi$$^2$= 0.23, p>0.05).

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Development of the Dissolution Test for Viquidil Hydrochloride Capsules and Alibendol Tablets (염산비퀴딜 캡슐 및 알리벤돌 정의 용출시험에 관한 연구)

  • Hwang, Joung-Boon;Koo, Eun-Joo;Go, Seu-Youn;Cho, Kyung-Chul;Moon, Hyun-Ju;Cho, Soo-Yeul;Kang, Chan-Soon;Shon, Yeo-Won;Kim, Young-Ok;Sohn, Kyung-Hee;Cho, Dae-Hyun
    • YAKHAK HOEJI
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    • v.54 no.5
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    • pp.348-353
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    • 2010
  • The dissolution test method and an analytical procedure by HPLC were developed and validated for viquidil hydrochloride capsules and alibendol tablets. These drugs were not yet characterized by the dissolution specifications in Korean Pharmaceutical Codex. So, with each reference and test drugs, we did the preliminary and standard experiments based on the Korean Pharmacopeia Guideline of dissolution testing for solid oral dosage forms. The dissolution test for viquidil hydrochloride capsules was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 50 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 30 min in this method. Also the dissolution test for alibendol tablets was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 100 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 45 min in this method. The dissolution samples were analyzed with a precise and accurate HPLC method. The developed dissolution test showed specificity, linearity, precision and accuracy within the acceptable range. The dissolution testing method described above was adequate for the purpose and may be proposed as a pharmacopeial standard to assess the performance of viquidil hydrochloride capsules and alibendol tablets.

Studies on Flowering and Maturity in Sesame(Sesamum indicum L.) VI. Grain Filling Rate for Differently Positioned Capsules in Different Plant Types (참깨 개화, 등숙에 관한 연구 VI. 참깨 초형에 따른 착삭부위별 등숙율)

  • Jung-Il Lee;;Eung-Ryong Son
    • KOREAN JOURNAL OF CROP SCIENCE
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    • v.31 no.2
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    • pp.214-219
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    • 1986
  • This study was conducted to provide basic information to breeders and agronomists working with sesame. Grain filling rate were investigated for eight plant types classified by branching habit, capsules per axil, carpels and loculi of a capsule. Two typical cultivars were chosen for plant type among 527 gene pools. Grain filling rate didn't increase with little difference between lower and middle part capsules, Jut significantly decreased in upper part. Grain filling rate of lower part, main stem and center capsules appeared higher than that of upper part, branch and side capsule for grain filling. Mono-capsule setting and unbranched plant type were higher for grain filling than tricapsule setting and branched type due to inactive ripenness on branched capsule. NMB type showed that best maturity and relatively good grain filling in BTB type despite it's largest sink capacity. NTQ and BTQ type appeared poor ripenness because of immaturity of higher part side capsules; however it was believed that there were still possibilities for improving ripenness in 3 capsule and 4 carpels 8 loculi type by the good maturity of 1 capsule and 4 carpels 8 loculi type.

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Effect of Rheological Properties on the Sedimentation of Capsules in an Aqueous Polymer Solution (고분자 수용액의 레올러지 특성이 캡슐의 침강에 미치는 영향)

  • Kim, Dong-Joo;Kim, Jung-Ah;Kyong, Kee-Yeol;Yoon, Moung-Suk
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.31 no.1 s.49
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    • pp.85-89
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    • 2005
  • An aim of this study is to study the correlation between rheological properties and sedimentation of capsules in aqueous polymer solution with low viscosity. Rheological properties of aqueous polymer solutions were controlled by carbomer (C), acylate/C10-30 alkyl acylate crosspolymer (AC), and ammonium acryloyldimethyltaurate/VP copolymer (AV). Small amount of polymer C solution had the highest viscosity and yield stress of polymer AV solution was higher than that of polymer C solution in the same viscosity when the concentration of polymer AV exceeded $0.35 wt\%$. Each aqueous polymer solution was tested and the results showed that as viscosity and yield stress increased, the sedimentation ratio of capsules decreased. The viscoelasticity data also showed the same tendency in a shear stress range of 0.1 to 2.0 Pa. These results demonstrated that the rheological properties of polymer solutions had a strong correlation with the sedimentation of capsules. When polymer I and AV were used, there was a synergistic effect and the correlation between rheological properties and sedimentation of capsules was very complicated. It was assumed that the characteristics of polymer structure and interaction between polymers caused this phenomena.

Study on the Performance Testing of the Closed Ice Thermal Energy Storage System using Screw Capsules (스크류 캡슐형 밀폐식 빙축열시스템의 성능시험에 관한 연구)

  • Kim, Kyung-Hwan
    • Journal of the Korean Solar Energy Society
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    • v.26 no.4
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    • pp.39-45
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    • 2006
  • The decrease in the summer peak electric load in our country is very important. The government has arranged and implemented a lot of support policies and statutes to decrease the peak electric load. And the ice thermal energy storage system is known as one of the alternatives. The purpose of this paper is to evaluate the efficiency and thermal characteristics of the closed ice thermal energy storage system using screw capsules. The measured thermal energy storage density is about 18.4 USRT-h/m3 (=232.9 MJ/m3), which is higher than 13.0 USRT-h/m3 (=164.6 MJ/m3), a low criterion of normal performance. And The efficiency of the discharging process and the total energy utilization is 96.2% and 2028.4 kcal/kWh respectively.

Model of Encapsulated Ice 510 Storage Tanks Using Charge and Discharge Performance of Single Ice Capsule (단일캡슐 축방냉성능을 이용한 캡슐형 빙축열조 모델)

  • 이경호;주용진;최병윤;김상준
    • Korean Journal of Air-Conditioning and Refrigeration Engineering
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    • v.12 no.4
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    • pp.337-344
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    • 2000
  • The present study describes a one-dimensional modeling of encapsulated ice storage tanks. The thermal transmittance of capsules in this model uses the results from the Arnold's experimental $study^{(2-3)}$.In this model, ice storage tank is partitioned by several control volumes for the analysis, each having same number of capsules. The model is validated by the comparison of the measured data from an ice storage tank installed at a building with the capacity of 1200 ton-hrs and the simulated results with the same inlet brine temperature conditions into the tank.

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The Effect of Processing Parameters to Manufacture Self-healing Microcapsules for Composite Materials (복합재료의 자가 치료용 캡슐 제작시 공정 변수들의 영향)

  • Yoon, YoungKi;Yoon, HiSeak
    • Journal of the Korean Society for Precision Engineering
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    • v.18 no.4
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    • pp.135-141
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    • 2001
  • An experimental study to find the effect of processing parameters for self-healing microcapules is performed. These microcapsules can be applied to accomplish the healing of delamination damage in woven E-glass/epoxy composites. This paper introduces the self-healing concept and presents a method for solving the microcapsule size and shape. Additionally, processing parameters are varied during the formation of microcapsules and these capsules are observed through optical microscope. To obtain thermogravimetric(TG) curve for the manufactured microcapsules, TGA tests are executed. From these results, the best processing conditions for the formation of capsules are found as follows: (1) temperature of solution $ 50^{\circ}C$, (2) potential of hytdrogen(pH) 3.5ppm, and (3) agitation 500~600rpm.

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