유방통을 호소하는 한국 여성에서 Gamma Linolenic acid의 임상적인 효과

정재헌,김권천,조현진,민영돈,김성환,김정용,장정환 조선대학교 부설 의학연구소 2000 The Medical Journal of Chosun University Vol.25 No.1

Background and Objectives : Recently, the incidence of breast cancer is gradually increasing in korea. Many patients visit the hospital with a fear of breast cancer, if she had the pain in her breast. But Breast pain is not a cardinal sign of breast cancer. Only 7% of patient in breast cancer has breast pain. Materials and Method : To know the clinical effects of gamma-linolenic acid(GLA), we analyzed the medical records of 55 cases with breast pain, who visited the outpatient clinic of Chosun university hospital, between July of 1999 to December of 1999. Of the 55cases of breast pain, we analyzed 26 cases of patient with breast pain who was treated with GLA for 2 month and we excluded patients of breast pain who had breast mass or were treated with other drug. Results : 2 Patients we are dropped out because nausea and vomiting were developed, 4 Patient with breast pain were treated with GLA for 1 month, and relieved completely from mastalgia and 8 patients with breast pain were treated with GLA for 2 months and breast pain was relieved completelys. 4 patient had treatment for 2 months, were relieved slightly. But 8 patients with breast pain didn't reveal the relief of symptom after the intake of GLA. Conclusion : We conclude that GLA could be considered a first line drug in patients with mastalgia.

무코스타 정(레바미피드 100 mg) 에 대한 레바미드 정의 생물학적 동등성

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

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±2.26 years in age and 66.19±9.41㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 100㎎ 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 (Δ) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 12.62% and 17.63% 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 above 99.00% and 88.56%, respectively. The 90% confidence intervals were within ±20% (e.g., -9.96~4.82 and -4.54~16.09 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.

무코스타정(레바미피드 100mg)에 대한 레바미드 정의 생물학적 동등성

조혜영,정현철,오인준,문재동,이용복 한국약제학회 2001 Journal of Pharmaceutical Investigation Vol.31 No.4

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±2.26 years in age and 66.19±9.41 kg in body weight, were divided into two groups and a randomized 2×2 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 (Δ) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 12.62% and 17.63% 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 above 99.00% and 88.56%, respectively. The 90% confidence intervals were within 20% (e.g., -9.96∼4.82 and -4.54∼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.

그란닥신 정(토피소팜 50 mg)에 대한 토핌 정의 생물학적 동등성

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

Tofisopam is a new type of tranquilizer valuable for the relief of anxiety and tension in a wide range of emotional disorders. Tofisopam has the therapeutic characteristics of a minor tranquilzer and a mild stimulatory effect. The purpose of the present study was to evaluate the bioequivalence of two tofisopam tablets, Grandaxin^TM (Hwan In Pharmaceutical Co., Ltd.) and Tofim^TM (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 23.11±2.83 years in age and 65.43±7.64㎏ in body weight, were divided into two groups and a randomized 2 x 2 cross-over study was employed. After one tablet containing 50㎎ of tofisopam was orally administered, blood was taken at predetermined time intervals and the concentrations of tofisopam in serum were determined using HPLC method with UV detector. 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 Grandaxin^TM were -5.59%, 2.22% and -13.18%, respectively. Minimum detectable differences (Δ) at α=0.10 and 1-β=0.8 were less than 20% (e.g., 14.95% and 19.34% for AUC_t and C_max, respectively). The powers (1-β) at α=0.10, Δ=0.2 for AUC_t and C_max were 95.21% and 81.93%, respectively. The 90% confidence intervals were within ±20% (e.g., -15.64∼4.45 and -10.77∼-15.21 for AUC_t, and C_max, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Tofim^TM tablet is bioequivalent to Grandaxin^TM tablet.

그란닥신 정(토피소팜 50mg)에 대한 토핌 정의 생물학적 동등성

조혜영,정현철,허수희,임동구,문재동,이용복 한국약제학회 2001 Journal of Pharmaceutical Investigation Vol.31 No.2

Tofisopam is a new type of tranquilizer valuable for the relief of anxiety and tension in a wide range of emotional disorders. Tofisopam has the therapeutic characteristics of a minor tranquilzer and a mild stimulatory effect. The purpose of the present study was to evaluate the bioequivalence of two tofisopam tablets, Grandaxin^TM (Hwan In Pharmaceutical Co., Ltd.) and Tofim^TM (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 23.11±2.83 years in age and 65.43±7.64 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 50 mg of tofisopam was orally administered, blood was taken at predetermined time intervals and the concentrations of tofisopam in serum were determined using HPLC method with UV detector. 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 Grandaxin^TM were -5.59%, 2.22% and -13.18%, respectively. Minimum detectable differences (Δ) at α=0.10 and 1-β=0.8 were less than 20% (e.g., 14.95% and 19.34% for AUC_t and C_max respectively). The powers (1-β) at α=0.10, Δ=0.2 for AUC_t and C_max were 95.21% and 81.93%, respectively. The 90% confidence intervals were within ±20% (e.g., -15.64∼4.45 and -10.77∼15.21 for AUC_t and C_max respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Tofim^TM tablet is bioequivalent to Grandaxin^TM tablet.

체내동태 연구를 위한 혈청 중 펜톡시필린의 HPLC 정량법 개발 및 검증

조혜영,강현아,류희두,이화정,문재동,이용복 한국약제학회 2006 Journal of Pharmaceutical Investigation Vol.36 No.2

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.

조갑진균증에서 Ciclopirox Nail Lacquer의 치료효과

박경찬,김정애,방형돈,조광현,윤재일,김병수 대한감염학회 1995 감염 Vol.27 No.3

배경 및 목적:조갑진균증의 치료에 있어 국소용 항진균제는 조갑판을 통과하지 못하기 때문에 치료율이 낮은 것으로 알려졌으나 최근 조갑판을 통과하여 조상에서도 높은 치료농도를 유지할 수 있는 국소용 항진균제인 ciclopirox nail lacquer가 개발되었다. 이에 본 저자들은 8% ciclopirox nail lacquer 단독 도포의 조갑진균증에서의 치료 효과와 안전성을 알아 보기 위한 연구를 수행하였다. 방법:표적 조갑판의 감염된 면적의 비율이 50%이하인 경증의 조갑진균증 환자 27명을 평가 대상으로 하였으며 8% ciclopirox nail lacquer 1일 1회 도포요법으로 6개월간 치료하였다. 매 방문시마다 감염면적 비율을 기록하였고 치료 전과 치료 후 진균 검사를 시행하였다. 결과: 1)표적조갑판의 감염 면적이 치료 전 평균 28.9%에서 치료 종료시 4.7%로 통계적으로 유의하게 감소하였다(p<0.001). 2)KOH 직접 도말 검사와 진균 배양 검사에서 모두 음성인 진균학적 완치율은 치료 종료시 77.8%였다. 3)부작용으로는 3명(11.1%)에서 일시적 작열감, 조갑 감입 등을 호소하였다. 결론:경증의 조갑진균증 치료에 있어 8% ciclopirox nail lacquer는 비교적 좋은 치료 효과를 보이며 부작용이 적은 약제로 생각된다. Background: Topical antifungal agents have been ineffective in the treatment of onychomycosis because they could not reach the infected nail bed. 8% ciclopirox nail lacquer is a new topical antimycotic which is characterized by excellent penetration into the nail plate. We performed a study to assess the therapeutic efficacy and safety of 8% ciclopirox nail lacquer in the treatment of onychomycosis. Methods: We assessed 27 onychomycotic patients whose affected area of target nail plate was not more than 50%. The patients were instructed to apply 8% ciclopirox nail lacquer once daily and evaluated monthly for 6 months. Mycological examinations were done before and after the treatment. Overall efficacy, tolerability, cosmetic acceptance and adverse effects were assessed at the end of 6 months' treatment. Results: The mean percentage of affected area decreased from 28.9% to 4.7%. Mycological cure rate was 77.8% at the end of the treatment. Overall efficacy assessed by physician and patients were similar and evaluated as complete cure in 48% and 44%, respectively. Tolerability and cosmetic acceptance were excellent or good in most of the patients. No systemic adverse effects were found, but 3 patients complained of mild prickling sensation or ingrowing toe nail. Conclusions: These data suggest that 8% ciclopirox nail lacquer is safe and effective in the treatment of mild onychomycosis.

효율적인 유비쿼터스 정보 공동활용을 위한 국가적 USN 정보자원 관리체계 구축 정책에 관한 연구

이재호,안철현,김유정,신상철,이재용 한국정보사회진흥원 2006 정보화정책 Vol.13 No.2

정보화 사회를 지나 유비쿼터스 사회로 발전하기 위한 핵심 기술 중 하나인 USN은 최근 기상, 군사 분야 등을 중심으로 현장∙실증 시험이 활발히 추진되고 있으며, u-City 같은 실제 사업에 적용하는 방안도 적극 검토되고 있다. 하지만, 현재까지 실증시험 결과 USN간 연계를 위한 식별체계, 프로파일, 통신프로토콜, 데이터 형식 등이 상이하여 향후 상호 연동을 위한 추가 비용이 크게 증가할 것으로 예상되고, 이는 기존 정보화 사회에서 행정 정보 공동활용과 유사한‘선구축-후통합’에 따른 문제점을 답습할 가능성이 높아 보인다. 따라서 본 논문에서는 USN 정보공동활용을 위한 USN 기술표준 및 정보 관리 체계를 수립하여 전국적 USN 정보자원을 효율적으로 관리하기 위한 정책 방안과 이를 실현하기 위한 USIS(Ubiquitous Sensor Information System)1)를 함께 제안하였다.

랫드에서 단일시험법을 이용한 반하 물추출물의 생식독성시험

이기남,유욱준,백인정,연정민,남상섭,이범준,남상윤,김윤배,강현규,안병우,김대중,황방연,노재섭,홍정섭,성하정,김순선,조대현,윤영원 충북대학교 동물의학연구소 2006 Journal of Biomedical and Translational Research Vol.7 No.1

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