아젭틴 정(염산아젤라스틴 1 mg)에 대한 아젤라 정의 생물학적 동등성

조혜영,윤지훈,서유리,오인준,이성관,문재동,이용복 전남대학교 약품개발연구소 2001 약품개발연구지 Vol.10 No.-

Azelastine, a phthalazinone derivative, is an antiallergic agent which demonstrates histamine H_1-receptor antagonist activity and also inhibits histamine release from mast cells following antigen and non-antigen stimuli. Thus, azelastine may be useful in the management of both asthma and allergic disorders. The purpose of the present study was to evaluate the bioequivalence of two azelastine hydrochloride tablets, Azeptin^TM (Bu Kwang Pharmaceutical Co., Ltd.) and Azela^TM (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 22.44±2.01 years in age and 61.99±6.18㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After two tablets containing 1㎎ of azelastine hydrochloride per tablet were orally administered, blood was taken at predetermined time intervals and the concentrations of azelastine in serum were determined using HPLC with fluorescence detector. 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 were -6.45%, -2.60% and -7.14%, respectively, when calculated against the Azeptin^TM tablet. The powers (1-β) for AUC_t and C_max were 96.65% and 88.47%, respectively. Minimum detectable differences (Δ) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 14.40% and 17.65% for AUC_t and C_max, respectively). The 90% confidence intervals were within ±20% (e.g., -14.87∼1.97 and -12.92∼7.72 for AUC_t and C_max respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Azela^TM tablet is bioequivalent to Azeptin^TM tablet.

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

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

Acetyl-L-camitine (ALC), an endogenous component of the L-carnitine family, is a naturally existing molecule synthesized from L-carnitine (LC) by carmtine 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.) and L-Cartin^TM (Kuhn Il Pharmaceutical Co.), according to the guidelines of Korea Food and Drug Administration (KFDA). The ALC release from the two ALC tablets in vitro was tested using KP Ⅶ Apparatus Ⅱ method in various dissolution media (pH 1.2, 6.0 and 6.8). Twenty six normal male volunteers, 24.46±3.67 years in age and 64.45±5.54 ㎏ 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. The dissolution profiles of the two ALC tablets were similar in all the dissolution media. The 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 0.35%, 0.93% and 2.34%, respectively, when calculated against the Nicetile^TM tablet. The powers (1-β) for AUC_t and C_max were 98.72% and 85.48%, respectively. Minimum detectable differences (Δ) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 13.21% and 18.42% for AUC_t and C_max, respectively). The 90% confidence intervals were within ±20% (e.g., -7.38~8.09 and -9.86~11.72 for AUC_t and C_max, respectively). These two parameters met the criteria of KFDA for bioequivalence, indicating that L-Cartin^TM tablet is bioequivalent to Nicetile^TM tablet.

치매방지 작업기구 사용이 항산화효소 활성에 미치는 영향

조경혜,박정은,윤지윤,문세보,박효영,정인옥,이정원 서울여자대학교 자연과학연구소 2001 자연과학연구논문집 Vol.13 No.-

We developed an occupational therapy tool to maintain and improve the cognitive function for the elderly who have senile dementia. 86 elderly people took a mininal mental state examination (MMSE) for the therapy to perform the occupational therapy, and divided into three groups based on avarage ages and MMSE values. The occupational therapy was treated three times per week for 10 weeks. The results showed that there were significant differences in the performing scores before and after the treatment ; the scores for the occupational therapy were increased significantly (p<0.001) and the performing time was shortened from 6-week throughout 10-week regimen. This study was to examine the effect on the activity of antioxidant enzymes by occupational therapy. The activities of antioxidant enzymes such as catalase, Glutathion-6-phosphate dehydrogenase (G6PDH), and superoxide dismutase (SOD) were increased to the normal standard by the occupational therapy for the elderly having dementia. The recovery of activities of antioxidant enzymes was obvious in severe demented elderly compared to those in normal or mild demented elderly. These results suggest that the occupational therapy had an beneficial effect on the protection against the oxidative stress especially for severe demented elderly, and the occupational tool need to be modified so as to improve the protection against the oxidative stress for normal and/or mild demented elderly.

황색포도상구균 신속 검출용 간이 진단키트

김기영,박샛별,문지혜,이상대,이새롬,장윤정 충남대학교 농업과학연구소 2013 농업과학연구 Vol.40 No.2

This study was performed to develop a rapid test kit for pathogenic Staphylococcus in various samples. The rapid detection kit has been fabricated based on nitrocellulose lateral-flow strip. Colloidal gold and Staphylococcus antibodies were used as a tag and a receptor, respectively. Manually spotted Staphylococcus antibody and anti-mouse antibody on the surface of nitrocellulose membrane were used as test and control lines, espectively. Feasibility of the rapid kit to detect Staphylococcus aureus in samples were evaluated. The intensity of the color of the tes line started to increase with the samples in which higher concentration of the cells were contained. The sensitivity of the sensor was 106 cfu/mL Staphylococcus spiked in PBS. Also, the rapid test kit could detect 105 cfu/mL of Staphylococcus in chicken meat extract.

The Intrinsic Antimicrobial Activity of Bamboo Salt against Salmonella enteritidis

Moon, Ji-Hea,Shin, Hyun-Ah,Rha, Young-Ah,Om, Ae-Son The Korean Society of Toxicogenomics and Toxicopro 2009 Molecular & cellular toxicology Vol.5 No.4

Biological Engineering : Review ; The Importance of FACS Analysis in the Development of Aptamers Specific to Pathogens

( Ji Hea Moon ),( Giyoung Kim ),( Saet Byeol Park ),( Jongguk Lim ),( Changyeun Mo ) 한국농업기계학회 2014 바이오시스템공학 Vol.39 No.2

Purpose: This review aims to introduce aptamers and the methods of its development to improve the sensitivity andselectivity to target bacteria. In this review, we have highlighted current developments and directions in the pathogendetection based on aptamers. Background: Aptamers, the specific nucleic acid sequences, can bind to targets with highaffinity and specificity. Some of researches on the use of aptamers for the detection of pathogen have been reported inrecent years. Aptamers have more applicability than antibodies for the development of pathogen detection using biosensor;such as easy to synthesis and labeling, lack of immunogenicity, and a low cost of production. However, only few reports onthe development and use of aptamers for the detection of pathogen have been published. Review: Aptamers specific topathogen are obtained by whole-cell systematic evolution of ligands by exponential enrichment (SELEX) process. SELEXprocess is composed of screening random oligonucleotide bound with target cells, multiple separation and amplification ofnucleic acids, final identification of the best sequences. For improving those affinity and selectivity to target bacteria,optimization of multiple separating process to remove unbounded oligonucleotides from aptamer candidates and sortingprocess by flow cytometry are required.

Fermented Product Development of Cynanchum wilfordii Hemsley by Lactic Acid Bacteria and Bifidobacteria

Ji-Hea Moon,Ae-son Om,Hye Soon Kwon,Young-Jeon Kim,Geun Eog Ji 한국식품과학회 2004 Food Science and Biotechnology Vol.13 No.3

The Importance of FACS Analysis in the Development of Aptamers Specific to Pathogens

Moon, Ji-Hea,Kim, Giyoung,Park, Saet Byeol,Lim, Jongguk,Mo, Changyeun Korean Society for Agricultural Machinery 2014 바이오시스템공학 Vol.39 No.2

Purpose: This review aims to introduce aptamers and the methods of its development to improve the sensitivity and selectivity to target bacteria. In this review, we have highlighted current developments and directions in the pathogen detection based on aptamers. Background: Aptamers, the specific nucleic acid sequences, can bind to targets with high affinity and specificity. Some of researches on the use of aptamers for the detection of pathogen have been reported in recent years. Aptamers have more applicability than antibodies for the development of pathogen detection using biosensor; such as easy to synthesis and labeling, lack of immunogenicity, and a low cost of production. However, only few reports on the development and use of aptamers for the detection of pathogen have been published. Review: Aptamers specific to pathogen are obtained by whole-cell systematic evolution of ligands by exponential enrichment (SELEX) process. SELEX process is composed of screening random oligonucleotide bound with target cells, multiple separation and amplification of nucleic acids, final identification of the best sequences. For improving those affinity and selectivity to target bacteria, optimization of multiple separating process to remove unbounded oligonucleotides from aptamer candidates and sorting process by flow cytometry are required.

우리나라 영ㆍ유아용 조제식의 식품첨가물과 오염물질 기준 개선방안 연구

문지혜(Ji Hea Moon),이헌옥(Heon Ok Lee),심재영(Jae Young Shim),김인혜(In Hye Kim),신혜승(Hye Seoung Shin),원선임(Sun Im Won),백민경(Min Kyoung Paik),신형수(Hyoung Soo Shin),엄애선(Ae Son Om) 한국식품영양과학회 2008 한국식품영양과학회지 Vol.37 No.9

본 연구에서는 영ㆍ유아용 조제식의 안전성에 대한 소비자의 신뢰도를 회복하고 영ㆍ유아의 성장 및 발달에 도움이 되고자 우리나라, CODEX, EU, 호주 및 뉴질랜드의 영ㆍ유아용 조제식내 식품첨가물 및 오염물질 기준을 비교ㆍ분석하고 국내 영ㆍ유아용 조제식 기준의 문제점과 개선방안을 다음과 같이 제시하였다. 영ㆍ유아용 조제식내 식품첨가물 기준은 영양품질 개선을 목적으로 하는 영양 강화제와 식품에 첨가물 용도로 사용되는 식품첨가물로 분류하여 비교하였다. 영양 강화제의 경우 CODEX, EU, 호주 및 뉴질랜드에서는 영양소 유형에 따라 분류하여 제시한 반면, 우리나라에서는 영양 강화제의 명칭을 종합적으로 나열하여 제시하였다. 따라서 우리나라에서도 영양 강화제에 대하여 영양소별로 구분하여 제시할 필요성이 제기된다. 또한 첨가물 용도로 사용되는 식품첨가물의 경우 국내에서는 허용량이 규정되어 있지 않으므로 허용 식품첨가물의 명칭 및 최대 허용량을 제시하여 국제 기준과의 조화를 고려하도록 한다. 오염물질 기준의 경우 국내에서는 일부 위해 미생물(E. sakazakii, B. cereus)과 방사선 조사처리 기준만 설정되어 있으나, CODEX 및 EU는 농약 기준을, 호주 및 뉴질랜드는 위해 미생물(Staphylococcus aureus, Salmonella sp.)과 중금속중 납과 알루미늄의 최대 허용량에 대한 허용기준을 추가로 규정하고 있다. 따라서 우리나라 영ㆍ유아용 조제식의 안전성을 입증할 수 있는 과학적인 자료를 토대로 위해 미생물, 농약 및 기타 오염물질 기준을 정량적으로 추가 제시할 필요성이 제기된다. The aim of this study is to propose suggestions for establishing Korean regulatory standards of infant formula. Accordingly, the regulatory standards for food contaminants and additives in Korean infant formulas were compared and analyzed with those in CODEX, EU, Australia and New Zealand. Several suggestions for regulations were found from different countries. Firstly, it is advisable that additives for nutrient supplement of infant formula be classified as types of nutrients. Secondly, it is proposed that guidelines should be set on the maximum amount of additives in infant formula. Thirdly, pathogens such as Staphylococci and Salmonella of infant formula should be regulated. Finally, present regulations need to establish the maximum permissible levels of some pesticides, Pb and Al, that other countries are already regulating. These proposed recommendations would broaden the scope of infant formula regulatory standards needed for infants' health.

곰팡이 독소 동시 분석용 간이진단키트 최적화 연구

문지혜 ( Ji Hea Moon ),김기영 ( Gi Young Kim ),이상대 ( Sang Dae Lee ),박샛별 ( Saet Byeol Park ),김혁주 ( Hyeok Ju Kim ) 한국산업식품공학회 2012 산업 식품공학 Vol.16 No.3

This study was performed to develop and optimize a rapid strip kit for the dual-detection of Aflatoxin B1 (AF) and Ochratoxin A (OTA). The strip kit is composed of sample pad, conjugation pad, nitrocellulose membrane, and absorbent pad. Manually spotted mycotoxin-BSA conjugates and anti-mouse IgG on nitrocellulose membrane were used as the test line and the control line, respectively. Conditions for rapid and easy detection of mycotoxins, conjugation between toxin-MAbs and nano Au particles, pretreatment method of pads, and composition of standards solutions were optimized. Feasibility of the strip kit to detect AF and OTA were evaluated with standard samples. Test results were acquired in 10 min and the detection limits were 100 ppm for AF and OTA, respectively.