• Title/Summary/Keyword: 수재해

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Development of Dissolution Testing Method for Piracetam Tablets and Fenoterol Hydrobromide Tablets in Korean Pharmaceutical Codex (고시 수재 의약품 중 피라세탐 정 및 브롬화수소산페노테롤 정의 용출시험법 개발)

  • Kim, Eun-Jung;Lee, Jin-Ha;Park, Chan-Ho;Sohn, Kyung-Hee;Kim, In-Kyu;Kim, Dong-Sup;Sah, Hong-Kee;Choi, Hoo-Kyun
    • YAKHAK HOEJI
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    • v.55 no.4
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    • pp.324-331
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    • 2011
  • Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo performance, there are a number of drugs with no established dissolution specifications in Korean Pharmaceutical Codex (KPC). Among those commercially available, Piracetam Tablets and Fenoterol hydrobromide Tablets were selected to develop the dissolution testing method. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korea Food & Drug Administration (KFDA). The dissolution test for Piracetam Tablets was carried out under sink condition with distilled water as dissolution medium, paddle rotation speed at 50 rpm and medium volume of 900 ml. More than 80% of its label claim was released within 30 min. In case of Fenoterol hydrobromide Tablets, distilled water was also found to be suitable to ensure sink condition. The rotation speed of 50 rpm and 900 ml of dissolution medium were used to evaluate the dissolution profile. The dissolution rate of fenoterol hydrobromide was over 90% in 15 min. The HPLC analysis methods were validated in terms of accuracy, precision, specificity, linearity, quantitation limit and range. The results suggested that the analytical methods used are simple and suitable to measure the dissolution rate of piracetam and fenoterol hydrobromide. Therefore, the analysis methods could be utilized in setting dissolution specifications of Piracetam Tablets and Fenoterol hydrobromide Tablets in the revised version of KPC.

Establishment of Quantitative Method for Generic Drugs in Korea Pharmaceutical Codex Monograph (공정서 수재 의약품의 정량법 개선에 관한 연구)

  • Song, JaeYong;Jang, JinSeob;Jang, SeungEun;Kim, SunHoi;Kim, InKyu;Lee, GilBong;Lee, JeaMan;Kim, YongHee
    • YAKHAK HOEJI
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    • v.56 no.5
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    • pp.288-292
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    • 2012
  • The aim of the paper is to ameliorate old research methods of Korean Pharmaceutical Codex to adjust the newest scientistic level which is necessary to maintain quality of medical supplies effectively. After reviewing result of Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph, there are two items chosen for the methods - Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph which KFDA researched in 2010, arranged new measuring standard by having an experiment to set measuring method after obtaining each item. According to the result, The experiment includes a measuring method of two items; Nafronyl Oxalate Capsules, and Ticlopidine Hydrochloride Tablets. The research is ameliorated by research methods through several experiments such as High Performance Liquid Chromatography validation, preparing items, implement of trial-experiment and authentic experiment, and experiment on measuring method of regulations of Korea Pharmaceutical Codex. The experiments are taken opinions of experts in KFDA into consideration and wrote out a report of the new measuring method on each last item. The report is combined as each two experiment sections of analyzing method to maintain the quality on the basis of the research in 2010 on setting of dissolution specifications for oral solid dosage forms. The result of measuring method of medical supplies through modernizing trial method of oral solid dosage forms is available to be accurate. In conclusion, this study could contribute to promotion of public health by organizing a basis for safe and high quality of medical supplies in domestic market.

Screening of Traditional Herbal Medicines to Develop New Materials for Anti-aging and Anti-wrinkle in the Skin (전통 생약재에서의 항노화와 주름 개선 활성 신소재 탐색)

  • Lee Sang Eun;Son Dong Wook;Yoon Year Pill;Lim Tae Young;Cho Ja Wun;Kim Haen Su
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.31 no.2 s.51
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    • pp.147-152
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    • 2005
  • As a part of searching tot the natural components which inhibit the skin aging and wrinkle formation, the $80\%$ methanolie extracts of 121 species of traditional herbal medicines used to treat lung and skin disease were investigated for their in vitro anti-oxidative activity against 1,1-diphenyl-2-picrylhydrazyl (DPPH) and superoxide radicals, and inhibitory activity against elastase. We selected 9 kinds of the traditional herbal medicines showing inhibitory activities of winkle formation. The effective concentrations of 9 candidates for anti-wrinke/skin firming activity was less than 0.1 mg/mL, and there is no toxicity to cell viability at these concentrations. Through analysis of human skin primary patch test data, the traditional herbal medicines represented non-irritant materials. We suggest that these 9 candidates with ability to help anti-wrinkle/skin firming may be useful for functional cosmetic materials.

Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph - Nicametate Citrate Tablet, Norfloxacin Capsule (고시 수재 의약품의 용출규격 설정 - 구연산니카메테이트 정, 노르플록사신 캡슐)

  • Kim, Hee-Yun;Choi, Seon-Hee;Bang, Su-Jin;Han, Kyung-Jin;Choi, Sung-Hee;Baek, Ji-Yun;Kim, Dong-Sup;Kim, Young-Ok;Sohn, Kyung-Hee;Song, Young-Me;Sah, Hong-Kee;Choi, Hoo-Kyun
    • YAKHAK HOEJI
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    • v.54 no.5
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    • pp.362-369
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    • 2010
  • Despite the fact that the dissolution test can serve as an effective tool for drug quality control and prediction of in vivo drug performance, there are a number of drugs with no established dissolution specifications because they were developed quite a long time ago. Under this circumstances, KFDA started the new project that establishes dissolution method and specifications for drugs with no dissolution specifications listed in the Korea Pharmaceutical Codex (KPC). This project aims for promoting the appropriate management of oral solid dosage forms. Seoul regional KFDA selected 2 items, Nicametate citrate tablet and Norfloxacin capsule, for establishing dissolution specifications. We went through the following procedures to develop the dissolution method and specifications: (1) Validation of dissolution test equipment, (2) Purchase of test drugs, (3) Preliminary test with one of the test products (1 lot), (4) Validation of analysis methods (3 lots), (5) Final tests and cross tests among other laboratory to establish dissolution specifications, (6) Additional test with the other test drugs. The outcome of this study will be reflected in revision of the KPC. It is believed that the quality control and evaluation of oral solid dosage forms listed in KPC will be advanced with the revision which adds additional dissolution test and specifications for the drugs with no established dissolution specifications.

Modelling of Principal Stress Rotation in Ko Consolidated Clay (Ko-압밀점토지반속 주응력회전 현상의 모형화)

  • Hong, Won-Pyo;Kim, Tae-Hyeong;Lee, Jae-Ho
    • Geotechnical Engineering
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    • v.13 no.1
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    • pp.35-46
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    • 1997
  • The isotropic single-hardening constitutive model has been applied to predict the behavior of soils during reorientation of principal stresses in the field. The predicted response by the model agrees well with the measured behavior for a series of torsion shear tests performed on hollow cylinder specimens of Ko consoildated clay along various stress -paths. This indicates that the soil behavior during reorientation of principal stresses can be predicted by using the model with application of simple informations given by isotropic compression tests and conventional consolidated-undxained triaxial compression tests. Isotropic elasto-plastic soil behavior has been served during primary loading from both the torsion shear tests and the predictions by the model. However, the directions of maj or principal strain increment given by the model have not coincided with the directions for tests during stress reversal, such as unloading and reloading, within isotropic yield surface for Ko consolidated stress. This indicates that kinematic hardening model instead of isotropic hardening model should be developed to predict the soil behavior during stress reversal. The experimental strain increment vectors in the work-space have been compared with the directions expected for associated and nonassociated flow rules.

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Investigation on Products and Regulation of Flexible Adhesive Rubber Asphalt Type Sealant for the Development of Korea-China Joint Standard (점착유연형 고무아스팔트계 씰재의 한중 공동 품질관리 규정 개발을 위한 제품 및 기술기준 현황 조사)

  • An, Ki-Won;Kim, Dong-Bum;Choi, Su-Young;He, Xing-Yang;Oh, Sang-Keun
    • Journal of the Korean Recycled Construction Resources Institute
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    • v.7 no.4
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    • pp.323-332
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    • 2019
  • Non-curable rubberized polymer asphalt waterproof coating materials in Korea and China are manufactured without advanced quality control techniques and common standard, And they are exposed consistent water leakage problems. Import and application of Korean waterproofing products and installation methods is difficult in the present situation as the Chinese standard(JC/T 2428) is different in nature with the Korean counterpart products, And quality assurance is inevitable based on mutual standards. In order to resolve this issue, alternatives such as using standards provided by the ISO (International Organization for Standardization) are generally employed, but there is no such ISO standard as a waterproof material for non-curable rubberized polymer asphalt material. Furthermore, it is unreasonable to develop the ISO standard for rubber asphalt seals for exchange in terms of time and cost. This study proposes that the establishment of a quality standard that can be applied for both countries will be required via an joint international standard that outlines the properties of materials if applied in mutual trade exchange.

Ancient Dujiangyan Irrigation System and Geographical Conditions in the Western Part of Sichuan Basin in China (중국(中國) 사천분지(四川盆地) 서부(西部)의 고대(古代) 관개시설(灌漑施設)과 지역적(地域的) 여건(與件) - 도강언(都江堰)의 경우 -)

  • Lee, Joon-Sun
    • Journal of the Korean association of regional geographers
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    • v.8 no.1
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    • pp.65-82
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    • 2002
  • This study tries to examine the characteristics of the ancient Dujiangyan Irrigation System and geographical conditions in the western part of Sichuan Basin in China. The Dujiangyan System constructed in the third century B.C is located at the mouth of gorge of the River Mi. This spot shows that its altitude above sea level is higher than that of the three other rivers in this district. Also, this river reaches the maximum discharge. These facts reveal the spot has the great potentiality as an ideal location for man-made channels. Li Bing realized the "three magical projects": Yuzui and Jinggang Dyke(a water dividing dyke), Baopingkou(a water inlet), and Feishayan(a spillway). The dyke divided the River Min into two parts. The inner river is connected to the Baopingkou. And the Feishayan discharges flood and silt from the inner river to the outer. These projects have composed a scientific irrigation and drainage network. Finally, in the Chengdu Plain were digged a dozen channels for irrigation. Some of them are connected eastward to the River Bu. Since then the Dujiangyan System has been bring great benefits to agricultural production. This resulted in the population increase and establishment of new counties which have made the plain a "Land of Abundance".

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The Effects of Negative Pressure and Drain Spacing in the Horizontal Method for an Early Settlement of Dredged and Filled Grounds (해안준설매립토의 조기안정을 위한 수평배수공법에서 부압과 배수재 배치간격의 영향)

  • 김수삼;한상재;김병일;김정기
    • Journal of Korean Society of Coastal and Ocean Engineers
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    • v.15 no.1
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    • pp.1-10
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    • 2003
  • In this paper, the laboratory test results with middle-sired ,soil box test in modeling the in-situ installing of horizontal drains are discussed the estimation of the optimum negative pressure. The test was carried out in the different vacuum pressure conditions together with the measurement for the settlement and volume change of drained water by the installed drains during the consolidation process. After the test, the water content was measured to both directions of lateral distance from the drain and depth of the soil, to find out the distribution of ground improvement and strength enhancement. From the analysis on the distribution of water content, the gradual application of vacuum pressure to higher level by pre-determined stages starting from low vacuum pressure is found to be effective and desirable. In the comparison of the degrees of consolidation with elapsed time, the calculated value by the prediction method based on the Barren's conventional theory showed a good agreement with the measured value. With this, It is positively considered that the applicability of the prediction method based on Barren's theory to the practical design of horizontal drains can be justified such as in the calculation of drain spacing and consolidation period.

Development and validation of a HPLC method for the simultaneous determination of chlorquinaldol and promestriene in complex prescription (복방제제 내 클로르퀴날돌과 프로메스트리엔에 대한 HPLC 기반 동시분석법의 개발 및 밸리데이션)

  • Lee, Seul-Ji;Shin, Sang-Yeon;Shin, Hae-Jin;Lee, Jin-Gyun;Kim, Dong-Hwan;Lee, Su-Jung;Han, Sang-Beom;Park, Jeong-Hill;Lee, Jeong-Mi;Kwon, Sung-Won
    • Analytical Science and Technology
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    • v.25 no.2
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    • pp.152-157
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    • 2012
  • Currently, many types of compound preparations are being used but the quality control guidelines for their use are lacking. In case of single compound drug, the quality control methods are specified in the pharmacopeia. However, there is no method to simultaneously analyze compound preparations. In this study, a simple validated analytical method for HPLC separation of chlorquinaldol and promestriene is introduced. Validation was divided into categories including linearity, precision, accuracy (recovery) and system suitability. The contents of the products which are on the market were monitored using the validated analytical method and the robustness of the analytical method was tested by conducting an inter-laboratory validation.

The feasibility study for reclaimed wastewater reuse in Saek-dal of Jeju island (제주 색달하수처리장 방류수 재이용 타당성 평가)

  • Lee, Kwang-Ya;Kim, Hae-Do;Joo, Jin-Hun;Kim, Young-Jin;Kang, Su-Man
    • Proceedings of the Korea Water Resources Association Conference
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    • 2012.05a
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    • pp.439-439
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    • 2012
  • 본 연구의 목적은 색달하수처리장 방류수를 농업용수 및 조경용수 등으로 활용하기 위해 하수 처리수 재이용 사업 타당성을 분석하고자 한다. 색달하수처리장 하수재이용사업은 제주도의 지하수자원 보존과 수자원 이용의 고도화 및 방류수 재이용을 통한 갈수기 농업용수 보급으로 물자원(지하수)을 절약하고자 색달하수처리장을 대상으로 하수처리수를 농업용수로 공급하는 사업이다. 대상지역은 서귀포시 예래동에 위치하고 있으며, 중문관광단지가 소재한 마을로 제주관광의 중심지이다. 서귀포시의 총 인구는 153,797명이며 하수도 보급률은 77.7%이다('10 제주특별자치도 통계연보). 색달하수처리장이 위치한 예래동의 농지면적이 1,122ha이며, 밭(772.6)과 과수원(280.2) 등 제주도의 전형적인 농촌마을이다. 대상지역의 주요작물은 감귤, 무, 마늘, 양배추 등이 많이 재배된다. 제주도는 연평균 강수량이 1,832.6mm로 전국평균 1,274 mm 보다 많은 편이며, 월별 강수량은 6~8월까지 3개월 동안 연 강우량의 44%정도가 내려 여름 장마철에 집중되는 것으로 나타났다. 대상지구의 필요수량은 농업생산정비 계획설계기준에 제시된 방법을 이용하여 산정하였다. 지구내 재이용수를 공급할 관정 4개소의 총 설계 채수량은 $2,916m^3/day$, 급수면적은 125.0ha이며, 10년한발(가뭄)시 안정적인 농업용수 공급을 위하여 $4,964m^3/day$(농업용수 $3,834m^3/day$, 조경용수 $1,130m^3/day$)이 필요하다. 하수처리수 재이용을 위한 처리시설의 연간 유지관리비는 인건비, 전력비, 시설물 내구연한을 고려하여 적용 하였으며, 상수도 생산비 절감 비용과 하수재이용수 생산단가를 통한 단위 편익을 산정하면 401.5원/$m^3$ 이다. 연차별 수익으로 산정하여 비용 편익 비율(B/C Ratio)을 나타내면 1.22로 나타났다. 본 연구의 결과로부터, 대상지구의 수자원여건, 입지여건, 장래 수요, 등을 고려할 때, 제주 색달 하수처리장의 하수처리수의 농업용수재이용 사업은 타당성이 매우 높다고 할 수 있다. 그리고 특히 이 지역은 관광단지의 조경용수 수요(중문골프장 등)가 있어 용수의 유료공급이 가능하고 이를 유지관리비로 충당할 수 있어 타지역에 비해 사업의 경제성과 환경보전성이 매우 크다.

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