니세틸 정(아세틸-엘-카르니틴 500 mg)에 대한 뉴로세틸 정의 생물학적 동등성

조혜영,김은아,정현철,심영순,임동구,오인준,문재동,이용복 전남대학교 약품개발연구소 2001 약품개발연구지 Vol.10 No.-

Acetyl-L-carnitine (ALC), an endogenous component of the L-carnitine family, is naturally occurring molecule synthesized from L-carnitine (LC) by carnitine acetyl transferase. ALC has been shown to improve the cognitive performance of patients suffering from dementia of the Alzheimer's type and proposed for treating Alzheimer's disease in pharmacological doses. The purpose of the present study was to evaluate the bioequivalence of two ALC tablets, Nicetiler^TM (Dong-A pharmaceutical Co., Ltd.) and Neurocetil^TM (Kyung-Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration. Twenty six normal male volunteers, 22.80±2.76 year in age and 63.07 7.98㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 500㎎ of ALC was orally administered, blood was taken at predetermined time intervals and the concentrations of ALC in serum were determined using HPLC with fluorescence detector. Because of the presence of endogenous ALC, the calibration was performed using dialyzed serum. Pharmacokinetic parameters such as AUC_t, C_max and T_max were calculated and ANOVA 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 were 2.72%, -0.65% and -8.42%, respectively, when calculated against the Nicetile^TM tablet. The powers (1-β) for AUC_t and C_max were 94.87% and 87.17%, respectively. Minimum detectable differences (Δ) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 15.58% and 19.16% AUC_t and C_max, respectively). The 90% confidence intervals were within ±20% (e.g., -11.84∼6.41 and -10.57∼11.88 for AUC_t and C_max, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Neurocetil^TM tablet is bioequivalent to Nicetile^TM tablet.

니세틸 정(아세틸 - 엘 - 카르니틴 500mg)에 대한 뉴로세틸 정의 생물학적 동등성

조혜영,오인준,이용복,임동구,문재동,심영순,김은아,정현철 한국약제학회 2001 Journal of Pharmaceutical Investigation Vol.31 No.1

Acetyl-L-carnitine (ALC), an endogenous component of the L-carnitine family, is naturally occurring molecule synthesized from L-carnitine (LC) by carnitine acetyl transferase. ALC has been shown to improve the cognitive performance of patients suffering from dementia of the Alzheimer's type and proposed for treating Alzheimer's disease in pharmacological doses. The purpose of the present study was to evaluate the bioequivalence of two ALC tablets, Nicetile^(TM) (Dong-A pharmaceutical Co., Ltd.) and Neurocetil^(TM) (Kyung-Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration. Twenty six normal male volunteers, 22.80±2.76 year in age and 63.07±7.98 ㎏ in body weight, were divided into two groups and a randomized 2 × 2 cross-over study was employed. After one tablet containing 500 ㎎ of ALC was orally administered, blood was taken at predetermined time intervals and the concentrations of ALC in serum were determined using HPLC with fluorescence detector. Because of the presence of endogenous ALC, the calibration was performed using dialyzed serum. Pharmacokinetic parameters such as AUC_t, C_(max) and T_(max) were calculated and ANOVA 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 were 2.72%, -0.65% and -8.42%, respectively, when calculated against the Nicetile^(TM) tablet. The powers (1-β) for AUC_t and C_(max) were 94.87% and 87.17%, respectively. Minimum detectable differences (△) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 15.58% and 19.16% AUC_t and C_(max), respectively). The 90% confidence intervals were within ±20% (e.g., -11.84∼6.41 and -10.57∼11.88 for AUC_t and C_(max), respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Neurocetil^(TM) tablet is bioequivalent to Nicetile^(TM) tablet.

프레탈 정(실로스타졸 100 mg)에 대한 엘지실로스타졸 정의 생물학적 동등성

조혜영,임동구,신상철,문재동,이용복 전남대학교 약품개발연구소 2001 약품개발연구지 Vol.10 No.-

Cilostazol has both antithrombotic and cerebral vasodilating effects, and one of the mechanism is the selective inhibition of platalet cyclic AMP phosphodiesterase. Bioequivalence of two cilostazol tablets, the Pletaal^TM (Korea Otsuka Pharmaceutical Co.) and the LG Cilostazol^TM (LG Chemical Co.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers (20∼29 years old) were randomly divided into two groups and a randomized 2×2 cross-over study was employed. After oral administration of Pletaal^TM or LG Cilostazol^TM tablet (100㎎ cilostazol), blood samples were taken at predetermined time intervals and the serum cilostazol concentrations were determined using an HPLC method with UV/VIS detector. The pharmacokinetic parameters (AUC_t, C_max and T_max) were calculated and ANOVA was utilized for the statistical analysis. The results showed that the differences in AUC_t, C_max and T_max between two tablets based on the Pletaal^TM tablet were -5.39%, 2.32% and 4.26%, respectively. The powers (1-β) for AUC_t, C-max, and T_max were 83.81%, 96.02% and 91.04%, respectively. Minimum detectable differences (Δ) and 90% confidence intervals were all less than ±20%. All these parameters met the criteria of KFDA for bioequivalence, indicating that LG Cilostazol^TM tablet is bioequivalent to Pletaal^TM tablet.

외음부에 발생한 혈관근육섬유아세포종 1례

오혜근,구자봉,김동출,심재영,박정훈,박영균,임성철 조선대학교 2003 The Medical Journal of Chosun University Vol.28 No.1

We present a case of angiomyofibroblastoma of the vulva in a 32-year-old woman. The asymptomatic lesion measured 4×3cm and appeared as a gray-white myxoid mass on cut sections Histologically, it appeared as a relatively well-circumscribed spindle cell proliferation with alternating hypercellular and hypocellular areas and proliferation of thin-walled blood vessels. Immunohistochemically, the stromal cells expressed vimentin, CD34 and progesterone receptor, but not desmin, α-smooth muscle actin, S-100 protein and estrogen receptor. These features were similar to those of angiomyofibroblastoma as previously reported in the vulva except negativity for desmin A case of pathologically proven very rare tumor of angiomyofibroblastoma of the vulva is presented with a literature review

딜라트렌 정(카르베딜롤 25 mg)에 대한 카베롤 정의 생물학적 동등성

조혜영,이문석,박순철,임동구,문재동,이용복 전남대학교 약품개발연구소 2001 약품개발연구지 Vol.10 No.-

Carvedilol is an antihypertensive and antianginal compound that combines nonselective beta-adrenoceptor blocking and vasodilation properties and is devoid of intrinsic sympathomimetic activity. The purpose of the present study was to evaluate the bioequivalence of two carvedilol tablets, Dilatrend^TM (Chong Kun Dang Pharmaceutical Co., Ltd.) and Carvelol^TM (Dae Won Pharmaceutical Co., Ltd.), according to the prior and revised guidelines of Korea Food and Drug Administration (KFDA). The carvedilol release from the two carvedilol tablets in vitro was tested using KP ⅦI Apparatus Ⅱ method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution, water and blend of PSB80 into water). Eighteen normal male volunteers, 24.22±1.86 years in age and 64.81±4.56㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 25㎎ of carvedilol was orally administered, blood was taken at predetermined time intervals and the concentrations of carvedilol in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two carvedilol tablets were very 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 non-transformed and logarithmically transformed AUC_t, and C_max. The results showed that the differences in AUC_t, C_max and T_max between two tablets based on the Dilatrend^TM were 2.23%, -2.00% and 0.00%, respectively. Minimum detectable differences (Δ) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 13.55% and 17.61% for AUC_t and C_max respectively). The powers (1-β) at α=0.05, Δ=0.2 for AUC_t and C_max were 98.08% and 88.81%, respectively. The 90% confidence intervals were within ±20% (e.g., -5.69~10.16 and -12.30~8.30 for AUC_t and C_max, respectively). There were no sequence effect between two tablets in logarithmically transformed AUC_t and C_max. The 90% confidence intervals using logarithmically transformed were within the acceptance range of log(0.8) to log(l.25) (e.g., 0.95~1.11 and 0.89~1.09 for AUC_t and C_max, respectively). Two parameters met the criteria of prior and revised KFDA guideline for bioequivalence, indicating that Carvelol^TM tablet is bioequivalent to Dilatrend^TM tablet.

딜라트렌정(카르베딜롤 25mg)에 대한 카베롤 정의 생물학적 동등성

조혜영,이문석,박순철,임동구,문재동,이용복 한국약제학회 2001 Journal of Pharmaceutical Investigation Vol.31 No.4

Carvedilol is an antihypertensive and antianginal compound that combines nonselective beta-adrenoceptor blocking and vasodilation properties and is devoid of intrinsic sympathomimetic activity. The purpose of the present study was to evaluate the bioequivalence of two carvedilol tablets, Dilatrend^TM (Chong Kun Dang Pharmaceutical Co., Ltd.) and Carvelol^TM (Dae Won Pharmaceutical Co., Ltd.), according to the prior and revised guidelines of Korea Food and Drug Administration (KFDA). The carvedilol release from the two carvedilol tablets 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, water and blend of PSB80 into water). Eighteen normal male volunteers, 24.22±1.86 years in age and 64.81±4.56 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 25 mg of carvedilol was orally administered, blood was taken at predetermined time intervals and the concentrations of carvedilol in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two carvedilol tablets were very 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 non-transformed and logarithmically transformed AUC_t and C_max The results showed that the differences in AUC_t C_max and T_max between two tablets based on the Dilatrend^TM were 2.23%, -2.00% and 0.00%, respectively. Minimum detectable differences (Δ) at α=0.05 and 1-β=8 were less than 20% (e.g., 13.55% and 17.61% for AUC_t and C_max respectively). The powers (1-β) at α=0.05, Δ=0.2 for AUC_t and C_max were 98.08% and 88.81%, respectively. The 90% confidence intervals were within 20% (e.g., -5.69∼10.16 and -12.30∼8.30 for AUC_t and C_max, respectively). There were no sequence effect between two tablets in logarithmically transformed AUC_t and C_max, The 90% confidence intervals using logarithmically transformed were within the acceptance range of log(0.8) to log(1.25) (e.g., 0.95∼1.11 and 0.89∼1.09 for AUC_t and C_max respectively). Two parameters met the criteria of prior and revised KFDA guideline for bioequivalence, indicating that Carvelol^TM tablet is bioequivalent to Dilatrend^TM tablet.

가토에서 일측 요관 부분 및 완전폐색시 신장과 요관의 조직학적 변화

김상현,김용웅,육승모,한동석,노안식,임재성,김홍식,나용길,설종구 충남대학교 의학연구소 2003 충남의대잡지 Vol.30 No.2

This study was designed to clarify histologic changes in the experimental rabbit kidney and ureter after unilateral partial or complete ureteral obstruction. A total of 20 adult white rabbits were divided into 4 subgroups in the partial obstruction followed by 2 weeks, the partial obstruction followed by 4 weeks, the complete obstruction followed by 2 weeks, and the complete obstruction followed by 4 weeks. The normal control group was consisted of 5 adult white rabbits. The kidneys and ureters for light microscopy were fixed in 10% neutral formalin, embedded in paraffin and stained with hematoxylin and eosin. Abnormal histologic fingings showed in ipsilateral kidney and ureter of all subgroups(such as dilatation of uriniferous tubule, focal necrosis and desquamation of epithelium, interstitial fibrosis, glomerular congestion, widening of Bowman's space, dilatation of ureter, epithelial cell atrophy or loss, interstitial fibrosis and interstitial inflammation). These findings were most severe in the group of the complete-obstructed ureter for 4 weeks. No significant changes showed in contralateral ureter of all subgroups. The degree of obstruction was severe and period of obstruction was long, the histological changes in ipsilateral side were severe. Despite of changes in ipsilateral side no abnormal findings showed in contralateral side. We suggest that long term experimental investigation of histologic changes in ipsilateral side and compensatory changes in contralateral side have to be studied.

시클러 캡슐(세파클러 250㎎)에 대한 경보세파클러 캡슐의 생물학적동등성

조혜영,강현아,김세미,박찬호,오인준,임동구,문재동,이용복 한국약제학회 2005 Journal of Pharmaceutical Investigation Vol.35 No.1

The purpose of the present study was to evaluate the bioequivalence of two cefaclor capsules, Ceclor (Lilly Korea Co., Ltd.) and Kyongbocefaclor (Kyongbo Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of cefaclor from the two cefaclor formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2. 4.0. 6.8 buffer solution and water). Twenty four healthy male subjects. 22.96±1.52 years in age and 67.03±7.90 kg in body weight, were divided into two groups and a randomized 2x2 cross-over study was employed. After one capsule containing 250 mg of cefaclor was orally administered, blood was taken at pre-determined time intervals and the concentrations of cefaclor in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition. 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 Tmaa. The results showed that the differences between two formulations based on the reference drug, Ceclor. were -1.90%, 2.68% and -7.60% for AUCt, 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 0.91-log 1.06 and log 0.92-log 1.18 for AU', and C_(max), respectively). Thus. the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kyongbocefaclor capsule was bioequivalent to Ceclor capsule.

유한세프라딘 캅셀(세프라딘 500 mg)에 대한 브로드세프 캅셀의 생물학적 동등성

조혜영,이석,강현아,오인준,임동구,문재동,이용복 전남대학교 약품개발연구소 2002 약품개발연구지 Vol.11 No.-

Cepharadine 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 bioequinalence of two cepharadine 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 ?? 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±2.90 years in age and 67.69±8.04 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one capsule containing 500 ㎎ as cephradine was orally administered, blood was taken at predetermined time intervals and the concentrations of cepharadine 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 phaemacokinetic 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 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 log(0.8) to log(1.25) (e.g., log(0.93)∼log(1.02) and log(0.88)∼log(1.13) for AUC_t, and C_max, respectively). the 90% confidence interval using untransformed data was within ±20% (e.g., -17.54∼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.

디푸루칸 캅셀(플루코나졸 50 mg)에 대한 플루코나 캅셀의 생물학적 동등성

조혜영,강현아,이석,오인준,임동구,문재동,이용복 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.2

Fluconazole is an orally active bis-triazole antifungal agent, which is used in the treatment of superficial and systemic candidiasis and in the treatment of cryptococcal infections in patients with the acquired immuno deficiency syndrome (AIDS). The purpose of the present study was to evaluate the bioequivalence of two fluconazole capsules, Diflucan(Pfizer Pharmaceuticals Korea Inc.) and Flucona (Korean Drug Pharmaceuticals Co., Ltd.), according to the guidelines of Korea Food and Drug Administration(KFDA). The fluconazole release from the two fluconazole capsules in vitro was tested using KP Ⅶ Apparatus Ⅱ method at 0.1M hydrochloride dissolution media. Twenty normal male volunteers, 23.60±1.88 years in age and 63.57±6.17㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After three capsules containing 50㎎ as fluconazole was orally administered, blood was taken at predetermined time intervals and the concentrations of fluconazole in serum were determined using HPLC method with UV detector. The dissolution profiles of two fluconazole capsules were very similar at 0.1M hydrochloride 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 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 Diflucan were 4.96%, 5.65% and -13.76%, 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 log(0.8) to log(1.25) (e.g., log(1.01)∼log(1.08) and log(1.00)∼log(1.12) for AUC_t and C_max respectively), indicating that Flucona capsule is bioequivalent to Diflucan capsule.