• Tuberculosis and Respiratory Diseases
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• 제41권1호
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• pp.1-10
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• 1994

연구배경 : 승모판 협착증 환자들은 폐기능검사상 제한성 및 폐쇄성 환기장애를 동시에 나타낼 수 있으며, 또한 운동능력의 장애가 있다는 것은 잘 알려져 있다. 이러한 폐기능의 장애는 수술적 판막교정술에 의해 일부 호전이 있었다고 보고되어 왔다. 이에 저자들은 흉부폐쇄하에서의 경피적풍선확장 승모판막성형술에 의해 승모판 협착증을 교정한후, 폐기능검사 및 운동능력의 호전 정도 및 시술후 사간적 경과에 따른 변화를 보기 위해 본 연구를 시행하였다. 방법 : 승모판 협착증을 가진 46명을 대상으로 하였으며 심초음파상 좌심방혈괴가 보이거나, 승모판 폐쇄부전증이 grade 2이상인 경우는 제외하엿다. 승모판 협착증의 교정전후 폐활량측정법, 폐확산능 및 운동부하검사를 시행하였으며 폐기능의 시간적 경과에 따른 변화를 보기 위하여 폐기능 및 운동부하검사의 추적검사를 11명의 환자에서 평균 5개월 후에 실시하였다. 그리고 동율동을 보인 29명의 환자를 폐동맥압에 의해 A, B 양군으로 나누고, 양군간의 판막성형술 전후 폐기능 및 운동부하 검사결과를 비교하였다. 결과 : 경피적풍선 확장 판막성형술후 평균 10일째 시행한 폐기능 및 운동부하검사결과를 수술전 검사 결과와 비교시, 노력성폐활량(FVC), 1초간노력성호기량($FEV_1$), 노력성호기중간유량($FEF_{25-75%}$), 최고호기유속(PEF), 최대산소섭취량($\dot{V}O_2$ max) 및 무산소역치(AT)등의 유의한 증가가 있었으며, 폐확산능(DLco)의 유의한 감소가 있었다. 한편 5개월뒤 추적 검사한 11명의 환자에서 시술직후와 비교시 폐기능 검사 및 운동부하 검사결과의 유의한 증가는 없었다. 동율동을 보인 29예를 폐동맥압이 35mmHg보다 높은 경우 A군(16예), 35mmHg 이하인 경우 B군(13예)으로 분류하였다. A군에서는 판막성형술전 FVC, $FEV_1,\;\dot{V}O2$ max가 B군보다 유의하게 낮았으나 판막성형술후 A군에서 B군보다 FVC, $FEV_1,\;\dot{V}O_2$ max의 유의한 증가를 보였다. 그리고 A군에서 판막성형술후 AT 및 $\dot{V}O2$ max에서의 분당 산소섭취량에 대한 분당환기량($\dot{V}E/\dot{V}O_2$)과 분당 이산화탄소 생산량에 대한 분당 환기량($\dot{V}E/\dot{V}O_2$)이 유의하게 감소하였으나, B군에서는 AT에서의 $\dot{V}E/\dot{V}O_2$ 및 $\dot{V}E/\dot{V}CO_2$는 유의한 감소를 보였으나, $\dot{V}O_2$ max에서의 $\dot{V}E/\dot{V}O_2$ 및 $\dot{V}E/\dot{V}CO_2$는 유의한 변화가 없었다. 결론: 1) 승모판협착증 환자에서 경피적풍선확장 판막성형술(PMV)후 1개월 이내 시행한 폐기능검사 및 운동부하 검사상 유의한 호전이 있었다. 2) 중등도 이상의 폐고혈압을 보인 승모판협착증 환자에서 폐동맥압 상승이 경미한 예보다 운동수행 능력의 유의한 증가가 있었다. 3) 중등도 이상의 폐고혈압을 보인 승모판협착증 환자에서 판막성형술후 운동능력의 유의한 호전은 분당 산소소모량에 대한 분당 환기량의 감소에 기인한 것으로 사료되었다.

• 대한치과기공학회지
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• 제31권2호
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• pp.23-30
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• 2009

All-ceramic restorations have gained acceptance among clinicians and patients because of their superior esthetics. Most all-ceramic systems have a 2-layer structure, using a weak veneering ceramic over a strong supporting core. often, failure of all-ceramic restorations occurs when the veneering ceramic fractures, exposing the core material. The purpose of this study was to compare the shear bond strength of heat press ceramic system (Zirpress) to zirconia core with various surface treatments. 10 metal cores and 50 zirconia cores were fabricated and divided into six groups according to surface treatment such as Zirliner application, aluminium oxide blasting, and 9.5% HF etching. Sixty specimens were prepared using Zirpress, veneered 8mm height and 3mm in diameter, over the zirconia cores (n=10). The shear bond strength test was performed in a universal testing machine with a crosshead speed of 1/min. Ultimate shear bond strength data were analyzed with One-way ANOVA and the Scheffe's test (p=.05). Within the limits of this study, the following conclusions were drawn: The mean shear bond strengths (MPa) were: 12.93 for $110{\mu}m$ aluminium oxide blasting/Rexillium III/IPS e.Max Zirpress; 14.92 for $50{\mu}m$ aluminium oxide blasting ${\pm}9.5%$ HF etching/Zirconis core/IPS e.Max Zirpress; 16.37 for $110{\mu}$ aluminium oxide blasting + 9.5% HF etching/Zirconis core/IPS e.Max Zirpress; 12.89 for $200{\mu}$ aluminium oxide blasting + 9.5% HF etching/Zirconis core/IPS e.Max Zirpress; 19.30 for 9.5% HF etching/Zirconis core/IPS e.Max Zirpress; 19.55 for Zirliner/Zirconis core/IPS e.Max Zirpress. The mean shear bond strength for ZNTZH (Zirliner/Zirconis core) and ZNTEH (9.5% HF etching/Zirconis core) were significantly superior to MS110H ($110{\mu}$ aluminium oxide blasting/Rexillium III) and ZS200EH ($200{\mu}$ aluminium oxide blasting + 9.5% HF etching/Zirconis core) (p<0.05).

• Journal of Pharmaceutical Investigation
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• 제33권4호
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• pp.311-317
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• 2003

Felodipine is a calcium antagonist that lowers blood pressure by reducing peripheral resistance by meas of a direct, selective action on smooth muscle in arterial resistance vessels. Futhermore, it have been approved for the effective in angina pectoris and cardiac failure. The purpose of the present study was to evaluate the bioequivalence of two felodipine extended release (ER) tablets, Splendil (YuHan Corporation) and Stapin (Hana Pharmaceutial Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The felodipine release from the two felodipine formulations in vitro was tested using KP VIII Apparatus II method at pH 6.5 buffer solution. Twenty six healthy male subjects, $22.73{\pm}1.78$ years in age and $66.66{\pm}7.28\;kg$ in body weight, were divided into two groups and a radomized $2{\times}2$ cross-over study was employed. After two tablets containing 5 mg as felodipine were orally administered, blood sample was taken at predetermined time intervals and the concentrations of felodipine in serum were determined using column-switching HPLC method with UV detector. The dissolution profiles of two formulations were similar at pH 6.5 buffer solution. Besides, 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 between two formulations based on the Splendil were 2.53%, 1.32% and 18.32% 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 rage of log(0.86) to log(1.25) $(e.g.,\;log(0.86){\sim}log(1.20)\;and\;log(0.89){\sim}log(1.23)\;for\;AUC_t,\;C_{max},\;respectively)$. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Stapin ER tablet and Splendil ER tablet are bioequivalent.

• Journal of Pharmaceutical Investigation
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• 제36권3호
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• pp.201-207
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• 2006

Acetaminophen (paracetamol), a para-aminophenol derivative, has analgesic and antipyretic properties and weak anti-inflammatory activity. The purpose of the present study was to evaluate the bioequivalence of two acetaminophen tablets, $Tylenol^{\circledR}$ ER (Janssen Korea Ltd.) and Tylicol ER (Hana Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of acetaminophen from the two acetaminophen formulations in vitro was tested using KP VIll Apparatus II method with pH 1.2 buffer solution. Twenty six healthy male subjects, $22.8{\pm}1.99$ years in age and $65.6{\pm}8.03$ 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 650 mg as acetaminophen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of acetaminophen in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in pH 1.2 buffer solution. 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, $Tylenol^{\circledR}$ ER, were 2.84, 1.89 and -1.36% 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 $0.987{\sim}log$ 1.08 and log $0.944{\sim}log$ 1.17 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Tylicol ER tablet was bioequivalent to $Tylenol^{\circledR}$ ER tablet.

• Journal of Pharmaceutical Investigation
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• 제34권5호
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• pp.419-425
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• 2004

The purpose of the present study was to evaluate the bioequivalence of two propiverine hydrochloride tablets, BUP-4 (Jeil Pharm. Co., Ltd.) and Kuhnil Propiverine Hydrochloride (Kuhnil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The propiverine release from the two propiverine hydrochloride formulations in vitro was tested using KP VIII Apparatus II method with a variety of dissolution media (pH 1.2, 4.0, 6.8 buffer solutions, water and blend of polysorbate 80 into pH 6.8). Twenty six healthy male subjects, $23.73{\pm}2.79$ years in age and $67.04{\pm}7.93\;kg$ in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross-over study was employed. After one tablet containing 20 mg as propiverine hydrochloride was orally administered, blood was taken at predetermined time intervals and the concentrations of propiverine in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, 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 BUP-4 were 0.17%, 7.98% and 4.55% 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) $(e.g.,\;log(0.88){\sim}log(1.l2)\;and\;log(0.90){\sim}log(1.l5)\;for\;AUC_t\;and\;C_{max},\;respectively)$. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kuhnil Propiverine Hydrochloride tablet was bioequivalent to BUP-4 tablet.

• Biomolecules & Therapeutics
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• 제9권4호
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• pp.291-297
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• 2001

The bioequivalence of two triflusal products was evaluated with 20 healthy volunteers following single oral dose according to the guidelines of Korea Food and Drug Administration (KFDA). Trisa $l^{R}$ capsule (Whanin Pharm. Corp., Korea) and Disgre $n^{R}$ capsule (Myung-In Pharm. Corp., Korea) were used as test product and reference product, respectively. Both products contain 300 mg of trifusal. One capsule of test product or reference product was orally administered to the volunteers, respectively, by randomized two period crossover study (2$\times$2 Latin square method). Blood samples were taken at predetermined time intervals for 4 hours and the determination of trifusal was accomplished using semi-microbore HPLC equipped with automated column switching system. The analytical method with HPLC was validated according to the Bioanalytic Method Validation guideline by F7A prior to determining the plasma samples. The pharmacokinetic parameters (AU $C_{0-4h}$ $C_{max}$ and $T_{max}$) were calculated and ANOVA test was utilized for statistical analysis of parameters. As a result of the assay validation, the limit of quantification of trifusal in human plasma by current assay procedure was 50 ng/ml using 500 $\mu$l of plasma. The accuracy of the assay was from 97.76% to 116.51% while the intra-day and inter-day coefficient of variation of the same concentration range was less than 15%. Average drug concentration at the designated time intervals and pharmacokinetic parameters calculated were not significantly different between two products (p>0.05). The difference of mean AU $C_{olongrightarrow4hr}$, $C_{max}$, and $T_{max}$ between the two products (2.92, 4.39, and -2.44%, respectively) were less than 20%. The power (1-$\beta$) and treatment difference ($\Delta$) for AU $C_{olongrightarrow4hr}$ and $C_{max}$ were more than 0.8 and less than 0.2, respectively. Although the power for $T_{max}$ was under 0.8, $T_{max}$ of the two products was not significantly different from each other (p>0.05). These results satisfied the criteria of KFDA guideline for bioequivalence, indicating the two products of triflusal were bioequivalent.quivalent.ent.ent.

• Journal of Pharmaceutical Investigation
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• 제31권4호
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• pp.281-287
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• 2001

Rebamipide is a novel anti-gastric ulcer agent that has been reported to increase the synthesis of mucus, to increase the mucosal concentration of prostaglandin, and to promote rapid ulcer healing. The purpose of the present study was to evaluate the bioequivalence of two rebamipide tablets, $Mucosta^{TM}$ (Otsuka Korea Pharmaceutical Co., Ltd.) and $Rebamide^{TM}$ (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The rebamipide release from the two rebamipide tablets in vitro was tested using KP VII Apparatus II method at pH 6.8 dissolution media. Twenty normal male volunteers, $24.20{\pm}2.26$ years in age and $66.19{\pm}9.41\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 100 mg of rebamipide was orally administered, blood was taken at predetermined time intervals and the concentrations of rebamipide in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two rebamipide tablets were very similar at pH 6.8 dissolution media. Besides, 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. The results showed that the differences in $AUC_t$, $C_{max}\;and\;T_{max}$ between two tablets based on the $Mucosta^{TM}$ were -2.57%, 5.77% and -1.47%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 12.62% and 17.63% for $AUC_t,\;and\;C_{max}$, respectively). The powers $(1-{\beta})$ at ${\alpha}=0.05$, ${\Delta}=0.2$ for $AUC_t\;and\;C_{max}$ were above 99.00% and 88.56%, respectively. The 90% confidence intervals were within ${\pm}20%$ (e.g., $-9.96{\sim}4.82$ and $-4.54{\sim}16.09$ for $AUC_t\;and\;C_{max}$, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that $Rebamide^{TM}$ tablet is bioequivalent to $Mucosta^{TM}$ tablet.

• 한국임상약학회지
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• 제12권1호
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• pp.22-28
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• 2002

Aceclofenac, 2-[(2',6'-dichlorphenyl)amino]phenylacetoxiacetic acid, is a new nonsteroidal anti-inflammatory drug that belongs to the family of phenylacetic acids. It shows good tolerance and potent analgesic/antiinflammatory properties, and acts on cartilaginous chondriocytes, stimulating their repair mechanism. The purpose of the present study was to evaluate the bioequivalence of two aceclofenac products, $Airtal^{TM}$ tablet (Daewoong Pharmaceutical Co.) and $Acer^{TM}$ capsule (Kyungdong Pharmaceutical Co.), according to the guideliner of Korea Food and Drug Administration (KFDA). The aceclofenac release from the two aceclofenac products in vitro was tested using KP VII Apparatus II method at pH 7.8 dissolution media. Sixteen normal male volunteers, $23.13\pm2.03$ years in age and $66.33\pm7.08$ kg in body weight, were divided into two groups and a randomized $2\times2$ cross-over study was employed. After one tablet or capsule containing 100 mg of aceclofenac was orally administered, blood was taken at predetermined time intervals and the concentrations of aceclofenac in serum were determined using HPLC with UV detector. The dissolution profiles of the two aceclofenac products were very similar at pH 7.8 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. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two products were $6.50\%,\;-1.06\%\;and\;11.96\%$ respectively, when calculated against the $Airtal^{TM}$ tablet. The powers $(1-\beta)\;for\;AUC_t,\;C_{max}\;were\;89.82\%\;and\;82.84\%$, respectively. Minimum detectable differences $(\Delta)\;at\;\alpha=0.05\;and\;1-\beta=0.8$ were less than $20\%\;(e.g.,\;17.51\%\;and\;19.30\%\;for\;AUC_t,\;C_{max}$, ). The $90\%$ confidence intervals were within $\pm20\%\;(e.g.,\;-3.73\%\sim16.73\%\;and\;-12.34\%\sim10.22\%\;for\;AUC_t,\;C_{max},\;respectively)$. Two parameters met the criteria of KFDA for bioequivalence, indicating that $Acer^{TM}$ capsule is bioequivalent to $Airtal^{TM}$ tablet.

• Journal of Pharmaceutical Investigation
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• 제23권1호
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• pp.41-49
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• 1993

The bioequivalence of two omeprazole enteric-coated products was evaluated in 16 normal male volunteers (age 26-32 yr, body weight 57-75 kg) following single oral administration. Test product was enteric-coated KD-182 tablet (Chong Kun Dang Corp., Korea) and reference product was $Rosec^{\circledR}$ capsule containing enteric-coated pellets of omeprazole (Yuhan Corp., Korea). Both products contain 20 mg of omeprazole. One tablet or capsule of the test or the reference product was administered to the volunteers, respectively, by randomized two period cross-over study ($2\;{\times}\;2$ Latin square method). Average drug concetrations at each sampling time and pharmacokinetic parameters calculated were not significantly different between two products(p>0.05); the area under the concentrationtime curve to last sampling time (8 hr) $(AUC_{0-8hr})$ $(1946.5{\pm}675.3\;vs\;2018.3{\pm}761.6\;ng{\cdot}hr/ml)$, AUC from time zero to infinite $(AUC_{o-\infty})$ $(2288.6{\pm}1212.8\;vs\;2264.9{\pm}1001.3\;ng{\cdot}hr/ml)$, maximum plasma concentration $(C_{max})$ $(772.5{\pm}283.3\;vs\;925.8{\pm}187.7\;ng/ml)$, time to maximum plasma concentration $(T_{max})$ $(2.38{\pm}1.06\;vs\;2.34{\pm}1.09\;hr)$, apparent elimination rate constant $(k_{\ell})$ $(0.5339{\pm}0.2687\;vs\;0.5769 {\pm}0.2184\;hr^{-I})$, apparent absorption rate constant $(k_a)$ $(1.1536{\pm}0.5278\;vs\;0.9739{\pm}0.9507 hr^{-1})$ and mean residence time (MRT) $(3.13{\pm}0.73\;vs \;3.41{\pm}1.04\;hr)$. The differences of mean $(AUC_{0-8hr})$, $C_{max}$, $T_{max}$ and MRT between the two products (3.69, 19.83, 1.32 and 8.99%, respectively) were less than 20%. The power $(1-{\beta})$ and treatment difference $(\triangle)$ for $AUC_{o-8hr}$ $C_{max}$ and MRT were more than 0.8 and less than 0.2, respectively. Although the power for $T_{max}$ was under 0.8, $T_{max}$ of the two products was not significantly different each other(p>0.05). These results suggest that the bioavailability of KD-182 tablet is not significantly different from that of $Rosec^{\circledR}$ capsule. Therefore, two products are bioequivalent based on the current results.

• 한국식품영양과학회지
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• 제39권1호
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• pp.110-115
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• 2010

버찌분말을 첨가한 젤리(0, 1, 3, 5, 7, 10%)를 제조하여 항산화 활성 및 기계적, 관능적 품질 특성을 조사하였다. 젤리의 pH는 버찌분말 첨가에 의해 유의적으로 감소하였으며, 당도는 버찌분말을 7% 이상 첨가할 경우 증가하는 유의차를 나타내었다. 젤리의 색도는 버찌분말 첨가량이 증가할수록 명도가 유의적으로 감소하였으며 적색도 및 황색도는 버찌분말 첨가에 의해 증가하였으나, 버찌분말 첨가량의 증가에 따른 경향을 나타내지는 않았다. 젤리의 조직감은 버찌분말 첨가량이 증가할수록 경도, 씹힘성, 검성이 유의적으로 증가하였으며 탄력성 및 응집성은 유의차를 보이지 않았다. 젤리의 항산화 활성은 버찌분말 첨가량이 증가할수록 유의적으로 증가되었다. 관능검사 결과, 색, 냄새, 맛, 조직감, 전반적인 기호도에서 버찌분말 5% 및 1% 첨가군에서 높은 선호도를 나타내었다. 따라서 젤리에 대한 버찌분말의 첨가는 젤리의 항산화 특성 및 관능적 특성을 고려할 때 5% 첨가가 상품개발 가능성이 높은 것으로 판단되었다.