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      • 농약 기준 및 위해평가 국제화를 위한 농약 가공계수 연구

        조미현 ( Mihyun Cho ),이혜수 ( Hyesu Lee ),김명헌 ( Myungheon Kim ),배수빈 ( Subin Bae ),김서홍 ( Seo Hong Kim ),김동주 ( Dong Ju Kim ),경기성 ( Kee Sung Kyung ),임무혁 ( Moo-hyeog Im ) 한국환경농학회 2021 한국환경농학회 학술대회집 Vol.2021 No.-

        본 연구는 가공계수의 기초 연구 및 자료확보를 위하여 과일 등 농산물에 대한 가공계수 국제기준 설정 현황을 비교·분석하였으며, 10년간의 JMPR 보고서를 조사하여 가공방법 및 가공계수를 정리하여 CODEX의 농약 기준설정에 대한 근거 자료를 조사하였다. CODEX에 등록된 230종 농약 중 가공연구가 수행된 150여종 농약을 3개년(2019∼2021년)으로 나눈 다음, 연차별로 대상 식품에 대한 기준 설정 및 위해평가를 위한 섭취량 분리 및 가공계수를 제안하는 요약서 작성을 수행하였다. 2,4-D는 면실, 쌀, 밀, 레몬, 오렌지에 대한 가공연구가 제출되어 각 농산물별 위해평가에 사용 가능한 가공계수는 면실 정제유 0.07, 백미 <0.33, 밀가루 0.11, 레몬 주스 0.1, 오렌지 주스 0.1이었다. Acetochlor는 땅콩 버터 1.05, 땅콩 정제유 <0.4, 대두 정제유 0.11, 수수가루 0.46, 면실 정제유 0.08로 나타났으며, acibenzolar-S-methyl은 오렌지 주스 <0.625로 가공계수가 산출되었다. 또한, 국내 가공계수 산출 대상 농산물인 쌀을 가공 중 농약 감소율을 분석하여 대국민 홍보자료로 사용하기 위하여 쌀에 농약을 침지하여 실험을 진행하였다. 침지한 현미를 3가지 유형의 방법에 따라 1-6회 세척 후 각 횟수별 잔류농약 분석을 실시하여 농약 최적 감소법을 도출 하고자하였다. 방법 1은 손으로 원형을 그리며 세척하였으며, 방법 2는 손으로 원형을 그리며 1회 세척, 박박 문지르며 1회 세척 후 다시 원형을 그리며 세척하였다. 방법 3은 손으로 원형을 그리며 1회 세척, 박박 문지르며 3회 세척 후 다시 원형을 그리며 세척하였다. Buprofezin, etofenprox, tebufenozide 및 flubendiamide 농약의 MRL 20-30배 수준으로 침지한 시료의 경우 현미 세척 시 방법 1의 경우 11.4-62.2%, 방법 2는 28.3-63.4%, 방법 3은 29.2-70.9% 감소하였으며, 백미 세척 시 방법 1의 경우 25.5-75.9%, 방법 2는 36.4-65.2%, 방법 3은 35.5-67.9% 감소되었다. MRL 수준침지 시료의 경우 현미 세척 시 방법 1은 33.3-76.8%, 방법 2는 29.3-73.7%, 방법 3은 35.4-75.4%의 감소율을 나타내었으며, 백미의 경우 방법 1 37.5-83.7%, 방법 2는 37.5-84.6%, 방법 3은 37.5-86.5%로 나타났다. 따라서 쌀 세척 시 강하게 문지르며 세척하였을 때 4종 농약이 가장 많이 감소되었으며 6회 세척 시 모든 방법에서 농약이 50% 이상 감소되는 것으로 나타났다.

      • KCI등재SCOPUS
      • KCI우수등재
      • KCI등재

        유사인자를 사용하여 용출양상 유사성을 비교하는 방법에 대한 고찰

        조미현,김정호,이현태,사홍기 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.3

        Dissolution profile comparsions can be done virtue of the similarity factor (f₂). It is a logarithmic reciprocal square root transformation of the sum of squared error of % dissolution differences between profiles at several time points. It gives information on the degree of similarity between the two profiles: An f₂ value between 50 and 100 suggests the similarity/equivalence of the two dissolution curves being compared. The objective of this report was to provide a careful examination on the f₂metrics in detail. It was shown that f₂values exceeded 50, when relative differences in % dissolved between two products were less than 15% at all time points. The similarity factor value was also found to be greater than 50, in cases when absolute % dissolution differences were below 10% at all time points. Interestingly, the f₂value was changed by the number of the time points selected for calculation. In particular, f₂tended to have higher values, when the f₂metrics used a large number of time points in which % dissolved reached plateau. Finally, since the similarity factor was a sample statistics, it was impossible to infer type Ⅰ/Ⅱ errors and sampling error. Despite certain limitations inherited in the f₂metrics, it was easy and convenient to evaluate how similar the two dissolution profiles were.

      • KCI등재

        이중유제법에 근거한 미립자 제조 공정 중 단백질의 분산매로의 전이 양상

        조미현,최수경,사홍기 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.5

        ₃ The objective of this study was to investigate the patterns of protein leaching to an external phase during an ethyl acetate-based, double emulsion microencapsulation process. An aqueous protein solution (lactoglobulin, lysozyme, or ribonuclease; W₁) was emulsified in ethyl acetate containing poly-d,l-lactide-co-glycolide 75:25. The W₁/O emulsion was transferred to a 0.5% polyvinyl alcohol solution saturated with ethyl acetate (W₂). After the double emulsion was stirred for 5, 15, 30, or 45 min, additional 0.5% polyvinyl alcohol (W₂) was quickly added into the emulsion. This so-called quenching step helped convert emulsion microdroplets into microspheres. After 2-hr stirring, microspheres were collected and dried. The degree of protein leaching to W₂ and/or W₃ phase was monitored during the microencapsulation process. In a separate, comparative experiment, the profile of protein leaching to an external phase was investigated during the conventional methylene chloride-based microencapsulation process. When ethyl acetate was used as a dispersed solvent, proteins continued diffusing to the W₂ phase, as stirring went on. Therefore, the timing of ethyl acetate quenching played an important role in determining the degree of protein microencapsulation efficiency. For example, when quenching was peformed after 5-min stirring of the primary W₁/O emulsion, the encapsulation efficiencies of lactoglobulin and ribonuclease were 55.1 ± 4.2 and 45.3 ± 7.6%, respectively. In contrast, when quenching was carried out in 45 min, their respective encapsulation efficiencies were 39.6 ± 3.2 and 29.9 ± 11.2%. By sharp contrast, different results were attained with the methylene-chloride based process: up to 2 hr-stirring of the primary and double emulsions, less than 5% of a protein appeared in W₂. Afterwards, it started to partition from W₁ to W₂/W₃, and such a tendency was affected by the amount of PLGA75:25 used to make microspheres. Different solvent properties (e.g., water miscibility) and their effect on microsphere hardening were to be held answerable for such marked differences observed with the two microencapsulation processes.

      • KCI등재

        경구용 서방성/지연성 성형제품의 허가 후 변경사항 관리를 위한 SUPAC-MR 응용

        사홍기,조미현,박상애,윤미옥,강신정 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.3

        The objective of this study was to scrutinize the rationale of SUPAC-MR and its application in processing postapproval changes to modified release solid oral dosage forms. The types of postapproval changes that were primarily covered with SUPAC-MR included variations in the components and composition, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. SUPAC-MR defined levels of postapproval changes that the industry might make. Classification of such categories was based on the likelihood of risk occurrence and potential impact of changes upon the safety and efficacy of approved drug products. In most cases, the changes could be classified into 3 levels. It described what chemistry, manufacturing, and control tests should be conducted for each change level. The important tests specified in SUPAC-MR were batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. It then suggested what type of a filing report should be submitted to the FDA for each change level. In general, level 1 changes could be reported in an annual report, whereas level 2 and/or 3 changes could be submitted in changes-being-effected or prior approval supplements. It could be understood that the purpose of SUPAC-MR was to maintain the safety and quality of approved modified release solid oral dosage forms undergoing certain changes. At the same time, it contributed to providing a less burdensome regulatory process with the manufacturers when they wanted to make postapproval changes. European regulatory agencies also implemented SUPAC-like regulations in handling such changes to drug products. Therefore, in this study a recommendation was made for KFDA and the Korean industry to evaluate thoroughly the usefulness of these guidances and regulations in dealing with postapproval changes to modified release solid oral dosage forms.

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