위해성배제를 위한 의약품 평가에 관한 연구 : 경구용의약품의 균질성평가에 관한연구 (Ⅲ) Standardization of uniformity of dosage unit for oral dosage forms

윤미옥,강신정,이수정,최현철,김호정,박창훈,홍세령,김지선,김길수 식품의약품안전청 2001 식품의약품안전청 연보 Vol.5 No.-

의약품의 약효를 안전하게 나타내기 위해서는 정확한 용량의 복용이 중오하다. 정해진 용법 ·용량에 따라 투여를 하더라도 1회 복용단위당 항량이 균일하지 않으면 복용자의 의지에' 관계없이 과량 혹은 유효량에 디치지 못하는 양을 복용하게 되므로 복용단위당 유효성분의 균질성은 매우 중요하다. 이에 국내 시판 의약품 중 경구용 성형제제를 대상으로 중랸과 항랑의 균질성 평가 및 상관성에 대한 기초적 연굴를 통하여 함량군일성시험의 규긱 설정에 관한 기준을 마련하고자 하였다. 국내 시판 중인 총 560롯트의 경구용 성형제제에 대하여 주성분의 수 함량 등에 따라 븐류하고 함량시험, 중량편차, 함량균일성시험을 실새하여 중량편차와 함량균일성의 상관계수를 구하였으며, 상관성분석을 통하여 각 분류한 군에서 상관성 있는 것으로 나타난 롯트의 비을을 살펴보았다. 주성분 함유량 2% 미만, 혹은 2 mg 미만인 제제에서는 함량균일성으로의 관리가 필요한 것으로 나타났으며, 제형에 따라서는 당의정에서 상패적으로 상관성 있는 롯트의 수가 적게 나타나 함량균일성으로의 관리가 필요한 것으로 나타났다

Combination of Hydrophobic Filtration and Enrichment Methods for Detecting Bacillus cereus in Fresh-Cut Cabbage

Sujung Lee,Yukyung Choi,Heeyoung Lee,Sejeong Kim,Jeeyeon Lee,Jimyeong Ha,Hyemin Oh,Yewon Lee,Yujin Kim,Yohan Yoon,Soomin Lee 한국식품위생안전성학회 2018 한국식품위생안전성학회지 Vol.33 No.5

본 연구에서는 신선편이 양배추 내 Bacillus cereus의 최 적 증균 온도를 선정하고 증균배양액에 소수성필터를 적용하여 multiplex PCR의 검출률을 확인하였다. B. cereus 증균온도는 B. cereus 균주 5 개를 혼합하여 1 Log CFU/ mL이 되도록 증균배지에 접종하고 30oC, 37oC, 42oC에서 증균한 뒤 3시간 간격으로 MYP agar에 도말한 후 계수하여 선정하였다. 소수성필터 미적용 그룹은 B. cereus 균 주 5 개를 혼합하여 신선편이 양배추에 접종한 뒤 최적 증균온도에서 증균하였으며, 증균배양액을 가열하여 DNA 를 추출한 뒤 multiplex PCR을 진행하였다. 소수성필터 적용 그룹은 증균배양액을 소수성 필터에 적용하고 필터에 있는 균을 멸균증류수로 현탁한 뒤 가열하여 추출된 DNA 로 multiplex PCR을 진행하였다. 증균온도 확인 결과, 6시간 증균 시 42oC에서 증균된 샘플(5.4 ± 0.3 Log CFU/mL) 과 30oC에서 증균된 샘플(4.6 ± 0.6 Log CFU/mL) 간 유의 차가 확인되었다(p < 0.05). 소수성필터 적용 유무에 따른 multiplex PCR 결과, 1 Log CFU/g 접종된 샘플의 검출률이 소수성 필터 적용 전 60%(3/5)에서 100%(5/5)로 향상 되었다. 2 Log CFU/g 접종 샘플은 소수성필터 적용 전 80%(4/5)에서 소수성 필터 적용 후 100%(5/5)로 검출률이 증가하였으나, 3 Log CFU/g 접종 샘플은 소수성 필터 적용 전후 모두 100%(5/5)로 확인되었다. 이상의 결과를 통해 신선편이 양배추 내 B. cereus 검출 시 증균배양액에 소수성필터를 적용하고 multiplex PCR을 적용했을 때 신속하고 효율적인 검출이 가능할 것으로 판단된다. This study developed a rapid detection method for Bacillus cereus in fresh-cut cabbages. Fresh-cut cabbage samples were inoculated at 1-, 2- and 3-Log CFU/g, and pathogens were enriched in tryptic soy broth containing 0.15% polymyxin B at 30oC, 37oC, and 42oC to determine the detection limit and appropriate enrichment temperature for multiplex PCR detection. Enriched bacterial cells in enrichment broth were collected in a hydrophobic filter prior to DNA extraction for multiplex PCR. Filters were resuspended in distilled water, and DNA was extracted from the suspension. DNA samples were further analyzed by multiplex PCR. Detection limit of multiplex PCR was 5-Log CFU/mL. B. cereus cell counts were higher (P < 0.05) at 42oC than other temperatures. Detection rate of 1-, 2-, and 3-Log CFU/g inoculated samples were 60%, 80%, and 100% after enrichment respectively. However, when enriched samples were filtered with hydrophobic membrane filter, detection rates became 100%, regardless of inoculation level. Results indicate a combination of enrichment with hydrophobic filtration improves rapid detection efficiency of B. cereus in fresh-cut cabbage by multiplex PCR.

Combination of Hydrophobic Filtration and Enrichment Methods for Detecting Bacillus cereus in Fresh-Cut Cabbage

Lee, Sujung,Choi, Yukyung,Lee, Heeyoung,Kim, Sejeong,Lee, Jeeyeon,Ha, Jimyeong,Oh, Hyemin,Lee, Yewon,Kim, Yujin,Yoon, Yohan,Lee, Soomin The Korean Society of Food Hygiene and Safety 2018 한국식품위생안전성학회지 Vol.33 No.5

본 연구에서는 신선편이 양배추 내 Bacillus cereus의 최적 증균 온도를 선정하고 증균배양액에 소수성필터를 적용하여 multiplex PCR의 검출률을 확인하였다. B. cereus 증균온도는 B. cereus 균주 5 개를 혼합하여 1 Log CFU/mL이 되도록 증균배지에 접종하고 $30^{\circ}C$, $37^{\circ}C$, $42^{\circ}C$에서 증균한 뒤 3시간 간격으로 MYP agar에 도말한 후 계수하여 선정하였다. 소수성필터 미적용 그룹은 B. cereus 균주 5 개를 혼합하여 신선편이 양배추에 접종한 뒤 최적 증균온도에서 증균하였으며, 증균배양액을 가열하여 DNA를 추출한 뒤 multiplex PCR을 진행하였다. 소수성필터 적용 그룹은 증균배양액을 소수성 필터에 적용하고 필터에 있는 균을 멸균증류수로 현탁한 뒤 가열하여 추출된 DNA로 multiplex PCR을 진행하였다. 증균온도 확인 결과, 6시간 증균 시 $42^{\circ}C$에서 증균된 샘플($5.4{\pm}0.3Log\;CFU/mL$)과 $30^{\circ}C$에서 증균된 샘플($4.6{\pm}0.6Log\;CFU/mL$) 간 유의차가 확인되었다(p < 0.05). 소수성필터 적용 유무에 따른 multiplex PCR 결과, 1 Log CFU/g 접종된 샘플의 검출률이 소수성 필터 적용 전 60%(3/5)에서 100%(5/5)로 향상되었다. 2 Log CFU/g 접종 샘플은 소수성필터 적용 전 80%(4/5)에서 소수성 필터 적용 후 100%(5/5)로 검출률이 증가하였으나, 3 Log CFU/g 접종 샘플은 소수성 필터 적용 전후 모두 100%(5/5)로 확인되었다. 이상의 결과를 통해 신선편이 양배추 내 B. cereus 검출 시 증균배양액에 소수성필터를 적용하고 multiplex PCR을 적용했을 때 신속하고 효율적인 검출이 가능할 것으로 판단된다. This study developed a rapid detection method for Bacillus cereus in fresh-cut cabbages. Fresh-cut cabbage samples were inoculated at 1-, 2- and 3-Log CFU/g, and pathogens were enriched in tryptic soy broth containing 0.15% polymyxin B at $30^{\circ}C$, $37^{\circ}C$, and $42^{\circ}C$ to determine the detection limit and appropriate enrichment temperature for multiplex PCR detection. Enriched bacterial cells in enrichment broth were collected in a hydrophobic filter prior to DNA extraction for multiplex PCR. Filters were resuspended in distilled water, and DNA was extracted from the suspension. DNA samples were further analyzed by multiplex PCR. Detection limit of multiplex PCR was 5-Log CFU/mL. B. cereus cell counts were higher (P < 0.05) at $42^{\circ}C$ than other temperatures. Detection rate of 1-, 2-, and 3-Log CFU/g inoculated samples were 60%, 80%, and 100% after enrichment respectively. However, when enriched samples were filtered with hydrophobic membrane filter, detection rates became 100%, regardless of inoculation level. Results indicate a combination of enrichment with hydrophobic filtration improves rapid detection efficiency of B. cereus in fresh-cut cabbage by multiplex PCR.

Effects of Soybean Peptide Intake on Antioxidant Enzyme, Cortisol and Inflammatory Cytokines in High School Judo Athletes

Sujung Bae,Da Kyoung Lee,Chang-Seob Son,Hye-Sook Lee,Jang-Woon Lee,Yoon-Bok Lee,Yung-Choon Yoo,Jin-Hong Park,Seung Bok Hong,Seock-Yeon Hwang 대한의생명과학회 2012 Biomedical Science Letters Vol.18 No.1

The purpose of this study was to investigate the effect of soybean peptide on antioxidant enzymes, cortisol hormone and inflammatory cytokine levels. 19 high school male judo athletes participated in the experiments. They were randomly divided into two groups, one group took soybean peptide (S-peptide, n=10) 4 g a day for 4 weeks and the other group placebo (placebo group, n=9) for the same time. Blood samples were collected before intake, after 2 weeks intake and 4 weeks intake and these were analyzed for total antioxidant status (TAS), catalase (CAT), levels of cortisol hormone, tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6). As a result, the S-peptide group was significantly increased in TAS and CAT (P<0.05). The malondialdehyde (MDA) levels showed decrease after soybean peptide intake but there was no significant difference. In the levels of plasma cortisol which reflect stress status, there was significantly decreased in the S-peptide and placebo group after 4 weeks (P<0.05). There were significant decreases of TNF-α and IL-6 after 4 weeks in S-peptide group (P<0.05). These results suggest that the intake of soybean peptide can activate antioxidant defenses and decrease exercise-induced oxidative stress.

Effects of the Combination Herbal Extract on Working Memory and White Matter Integrity in Healthy Individuals with Subjective Memory Complaints : A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Kwon, Oran,Lee, Sunho,Ban, Soonhyun,Im, Jooyeon J.,Lee, Doo Suk,Lee, Eun Hee,Kim, Joohee,Lim, Soo Mee,Lee, Sang Gon,Kang, Ilhyang,Kim, Kyung-Hee,Yoon, Sujung,Lee, Sun Hea The Korean Society of Biological Psychiatry 2015 생물정신의학 Vol.22 No.2

Objectives The combination extract of four kinds of herbs, Gastrodia elata, Liriope platyphylla, Dimocarpus longan, and Salvia miltiorrhiza, has shown to have memory improving effects in mice. The aim of this study was to investigate the efficacy and safety of the herbal mixture for improving working memory as well as microstructural changes in white matter integrity in individuals with subjective memory complaints. Methods Seventy-five individuals with subjective memory complaints were assigned to receive either placebo (n = 15) or herbal mixture (low-dose group, n = 30 and high-dose group, n = 30) supplementation in an 8-week, randomized, double-blind, placebo-controlled clinical trial. Changes in working memory performance and fractional anisotropy (FA) values reflecting white matter integrity from baseline to 8-week endpoint were assessed. Results The herbal mixture group showed an increase in working memory performance compared to the placebo group (p for interaction = 0.001). In addition, the herbal mixture group showed an increase in FA values in the temporo-parietal regions (corrected p < 0.05), which are crucially involved in working memory function and are among the most affected regions in patients with cognitive impairments. Conclusions Findings from this study indicate that the herbal mixture may be a promising therapeutic option for individuals with subjective memory complaints.

Rapid Detection of Escherichia coli in Fresh Foods Using a Combination of Enrichment and PCR Analysis

Yukyung Choi,Sujung Lee,Heeyoung Lee,Soomin Lee,Sejeong Kim,Jeeyeon Lee,Jimyeong Ha,Hyemin Oh,Yewon Lee,Yujin Kim,Yohan Yoon 한국축산식품학회 2018 한국축산식품학회지 Vol.38 No.4

The objective of this study was to determine the minimum enrichment time for different types of food matrix (pork, beef, and fresh-cut lettuce) in an effort to improve Escherichia coli detection efficiency. Fresh pork (20 g), beef (20 g), and freshcut lettuce (20 g) were inoculated at 1, 2, and 3 Log CFU/g of Escherichia coli. Samples were enriched in filter bags for 3 or 5 h at 44.5℃, depending on sample type. E. coli cell counts in the samples were enriched in E. coli (EC) broth at 3 or 5 h. One milliliter of the enriched culture medium was used for DNA extraction, and PCR assays were performed using primers specific for uidA gene. To detect E. coli (uidA) in the samples, a 3–4 Log CFU/mL cell concentration was required. However, E. coli was detected at 1 Log CFU/g in fresh pork, beef, and fresh-cut lettuce after 5, 5, and 3-h enrichment, respectively. In conclusion, 5-h enrichment for fresh meats and 3-h enrichment for fresh-cut lettuce in EC broth at 44.5℃, and PCR analysis using uidA gene-specific primers were appropriate to detect E. coli rapidly in food samples.

Development and validation of a HPLC method for the simultaneous determination of chlorquinaldol and promestriene in complex prescription

이슬지(Seul Ji Lee),신상연(Sang-yeon Shin),신혜진(Hae-jin Shin),이진균(Jin Gyun Lee),김동환(Dong-Hwan Kim),이수정(Sujung Lee),한상범(Sang Beom Han),박정일(Jeong Hill Park),이정미(Jeongmi Lee),권성원(Sung Won Kwon) 한국분석과학회 2012 분석과학 Vol.25 No.2

신생아 중환자실 개방면회와 개방면회에 대한 부모 불안, 간호사의 태도

이유나(Yu-nah Lee),김은숙(Eunsook Kim),박소현(Sohyun Park),김안나(An Na Kim),이지윤(Jiyoon Lee),이금문(Keum Moon Lee),최수정(Sujung Choi),이은정(Eun-jung Lee) 한국근거기반간호학회 2014 근거와 간호 Vol.2 No.1

Purpose: The purpose of this study was to survey the visitation conditions in the Neonatal Intensive Care Unit (NICU) and to evaluate parents’ anxiety and nurses’ attitude about the open visitation policy. Methods: One group pre-posttest design was used. After the approval of the institutional review board was obtained, 22 parents and 58 nurses in the NICU participated in the survey between January and February in 2014.The visitation conditions were the number of patients who had visitors in the NICU for a whole day, total visitation hours, mean visitation hours and total number of visitation in a day. Before and after the open visitations were applied, the anxiety level of the patients and attitudes of the nurses were measured. Results: After the open visitation, all visitation conditions significantly increased. Parents’ anxiety score also significantly decreased after experiencing the open visitation (p=.023). However, nurses’ attitude was not different (p=.851). Conclusion: The open visitation can relive parents’ anxiety in the NICU but still nurses have some conflicts for applying the open visitation. It is necessary to prepare environmental infrastructure and educate nurses and parents to activate the open visitation in the NICU.

Impact Of Temperature On Soil Geochemical Properties And The Accumulation Of Heavy Metal(loid)s In Lettuce (lactuca Sativa L.)

Sujung Lee(이수정),Kyoung Kim(김경웅),Hangyeol Jeon(전한결) 대한환경공학회 2021 대한환경공학회 학술발표논문집 Vol.2021 No.11

Cryoprotectants for freeze drying of drug nano-suspensions: Effect of freezing rate

Lee, Min Kyung,Kim, Min Young,Kim, Sujung,Lee, Jonghwi Wiley Subscription Services, Inc., A Wiley Company 2009 Journal of Pharmaceutical Sciences Vol.98 No.12

<P>Drug nanoparticles are often prepared in a liquid medium, and a drying method such as freeze drying is used to convert them to an oral solid dosage form. When the dried form is reconstituted in an aqueous system, it may be redispersed to achieve its original particle size. The redispersibility of dried nanoparticles depends on the parameters of the freeze drying process. In this study, an apparatus with a freezing rate gradient was used to systematically investigate the effect of cryoprotectants on the redispersibility of nanoparticles as a function of freezing rate. Sucrose, lactose, mannitol, and polyethylene glycol were used as cryoprotectants for a naproxen nano-suspension. A fast freezing rate and a high cryoprotectant concentration were generally favored. However, under certain conditions, a slower freezing rate resulted in better redispersibility. This is probably because slow freezing can produce a more cryo-concentrated liquid phase, and the concentrated cryoprotectant in the liquid phase can more effectively protect the nanoparticles. An irreversible aggregation map was constructed as a function of the freezing rate and the cryoprotectant concentration, and shows both the favorable and unfavorable effects of cryoprotectants. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:4808–4817, 2009</P>