듀리세프 캅셀(세파드록실 500㎎)에 대한 하나세프 캅셀의 생물학적 동등성

조혜영,이석,문재동,이용복 한국약제학회 2002 Journal of Pharmaceutical Investigation Vol.32 No.2

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±2.43 years in age and 70.74±10.29 kg in body weight, were divided into two groups and a randomized 2×2 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 dissoluton 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(l.25) (e.g., log(0.95)∼log(1.05) and log(0.87)∼log(l.02) for AUC_t, and C_max, respectively). The 90% confidence interval using untransformed data was within ±20% (e.g., -6.75∼15.74 for T_max). All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Hanacef capsule is bioequivalent to Duricef capsule.

듀리세프 캅셀(세파드록실 500 mg)에 대한 하나세프 캅셀의 생물학적 동등성

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

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±2.43 years in age and 70.74±10.29 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one capsule containing 500 ㎎ 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)∼log(1.05) and log(0.87)∼log(1.02) for AUC_t and C_max, respectively). the 90% confidence interval using untransformed data was within ±20% (e.g., -6.75∼15.74 for T_max). All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Hanacef capsule is bioequivalent to Duricef capsule.

스프렌딜 지속정(펠로디핀 5㎎)에 대한 스타핀 지속정의 생물학적동등성

조혜영,강현아,이석,백승희,박은자,최후균,문재동,이용복 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.4

Felodipine is a calcium antagonist that lowers blood pressure by reducing peripheral resistance by means of a direct, selective action on smooth muscle in arterial resistance vessels. Furthermore, 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 Pharmaceutical 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±1.78 years in age and 66.66±7.28 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After two tablets containing 5 ㎎ 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 AUG_(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_(mzx), 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(0.86)∼log(1.20) and long(0.89)∼long(1.23) for AUC_(t) and 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.

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.

엘도스 캡슐(에르도스테인 300mg)에 대한 엘브론 캡슐의 생물학적 동등성

조혜영,이석,강현아,문재동,이용복 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.3

Erdosteine, the thiol derivatives chemically related to cysteine, is a mucolytic and mucoregulator agent which modulated mucus production and viscosity and increases mucoiliary transport. The purpose of the present study was to evaluate the bioequivalence of two erdosteine capsules, Erdos (Dae Woong Pharmaceutical Co., Korea) and Erblon (Kuhn Ⅱ Pharmaceutical Co., Korea), according to the guidelines of Korea Food and Drug Administration (KFDA). The erdosteine release from the two erodisteine capsules 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 and water). Twenty four healthy male subject, 23.33±2.06 years in age and 66.18±8.19 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After three capsules containing 300 ㎎ as erdostein were orally administered, blood was taken at predetermined time intervals and the concentrations of erdostein 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 log-arithmically transformed AUC_(t) and C_(max) and untransformed T_(max). The results showed that the differences between two formulations based on the Erdos were 0.20%, 1.10% and -9.44% 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 long(0.8) to log(1.25)(e.g., long(0.94)∼long(1.22) and log(0.92)∼log(1.20) for AUC_(t) and C_(max), respectively. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Erblon capsule and Erdos capsule are bioequivalent.

陸英修 女史의 奉仕理念 硏究 : Concerning her Philosophy on Social Service

秦惠淑 배화여자대학 1993 培花論叢 Vol.11-12 No.-

The purpose of this article is to study the idea of Madame Yook Young Soo's social service. She was assassinated on August 15th, 1974, but she had worked devotedly for many people in difficulties, in spite of her high social status. To analyze her social idea, the social activities of Madame Yook are divided as follows. First, she tried to actualize her idea through social education, she founded not only 'Jung Soo Vocational Institution' for the young people's technical education but also 'Children Hall' to show the importance of children education. Second, Madame Yook tried to realize her idea through social work, she established 'Yang Ji Association' which was one of social service organization, this association helped many people who were accommodated in all social welfare facilities of this country. Other than 'Yang Ji Association', she systematically organized many social bodies to serve nation wide. Third, Madame Yook's idea is consistent with the virture of woman's duty which is one of Korean traditional morality. In fact she enjoyed helping other people through her self-sacrifice. To conclude, the idea of Madame Yook is look up to by the all people in whole society. Today, in spite of her great works, it is very regret for her idea not to outcome good results.

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.

陸英修女史論 : 敎育事業理念을 中心으로 Her Educational Ideals and Contributions

秦惠淑 배화여자대학 1985 培花論叢 Vol.4 No.-

The present study is concerned with educational ideals and contributions of the former First Lady, Yook, Young Soo. Its purpose is fourfold: 1. To evaluate her educational ideals and contributions. 2. To illuminate the location of her educational ideals and contributions in the light of traditional education theories and systems. 3. To search the eucational theme of her educational ideals and contributions. 4. To serve as a good reference in the future as systemizing her educational ideals and contributions. In a word, her educational ideals and guiding principles can be integrated as wide scope educational theories based on the "practical education", "patriotic education", "moral education", and "humanistic education". The findings of the study are as follows: 1. Her educational ideals and guiding principles are based on her own personal experiences. 2. Her educational beliefs and practices are based on the patriotic education spirit in the light of her helping disadvantaged people bring up to a man of ability. 3. She had a strong will to establish national identity and concentrated on moral education in order to raise up right nationalism. 4. Her educational ideals can be characterized as humanistic education, because she tried to build up humanistic schools for the purpose of awakening and cultvating the nation.

기초화장용 제품 중 크림과 로션제의 안정성 평가방법

조혜영,이석,백승희,최후균,이용복 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.4

This study was attempted to develop the physicochemical and morphological stability test methods for the cream and lotion formulations among the cosmetic foundations and to provide the guidance for the stability methods with respect to basic emulsions and creams. With these developed stability test methods, we can evaluate the expired date or life time of the available basic cosmetics, especially basic lotions and creams. Also, the stability test methods established in this study can be used as a guideline to test physical and morphological stability of cosmetics in the future. Thus, we selected two types of basic cosmetics such as lotions and creams made by four different cosmetic companies and applied them to stability test methods depending on the temperature changes such as temperature cycling and freezing-thawing cycling test. After the temperature changes, the conductivity, turbidity, particle size, creaming ratio and pH changes of the creams and lotions were evaluated and morphological changes such as crystal formation, oder, color and feeling of the creams and lotions were also tested. As the results of the stability tests, all the tested creams and lotions except for one lotion were stable. Therefore, it may be concluded that these short-term accelerated stability tests as physical stability test depending on the temperature change study were suitable for the stability testing methods for the basic cosmetics and may be useful for the establishment of the guideline for the stability test of cosmetics.

리스페달 정(리스페리돈 2㎎)에 대한 리스펜 정의 생물학적 동등성

조혜영,박은자,강현아,백승희,이석,박찬호,문재동,이용복 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.2

The purpose of the present study was to evaluate the bioequivalence of two risperidone tablets, Risperdal (Janssen Korea Co., Ltd) and Rispen (Myung In Pharm. Co., Ltd), according to the guidelines of Korea Food and Drug Administration (KFDA). The risperione release from the two risperidone formulations in vitro was tested using KP Ⅷ Apparatus Ⅱ method with various of dissolution media (pH 1.2, 4.0, 6.8 butter solution and water). Twenty four healthy male subjects, 23.33±2.10 years in age and 69.24±8.05 kg in body weight, were divided into two groups and a randomized 2×2 crossover study was employed. After one tablet containing 2 ㎎ as risperidone was orally administered, blood was taken at predetermined time intervals and the concentration of risperidone 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) 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 Risperdal were 0.20, -1.29 and -11.09% 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(0.90)∼log(1.03) and log(0.84)∼log(1.09) for AUC_(t) and C_(max), respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Rispen tablet and Risperdal tablet were bioequivalent.