• Title/Summary/Keyword: 의약품사용평가

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Bioequivalence Evaluation of Two Cefquinome 2.5% Injectable Products in Piglets (돼지에서 두 가지 Cefquinome 2.5% 제제의 생물학적 동등성 평가)

  • Song, In-Bae;Kim, Tae-Won;Lee, Hong-Gee;Kim, Myoung-Seok;Hwang, Youn-Hwan;Park, Byung-Kwon;Lim, Jong-Hwan;Yun, Hyo-In
    • Journal of Veterinary Clinics
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    • v.29 no.3
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    • pp.233-236
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    • 2012
  • Cefquinome, a fourth generation cephalosporin, has been solely used for veterinary medicine and has a broad antibacterial spectrum against gram-negatives and gram-positives being very stable to ${\beta}$-lactamases. This study was conducted to evaluate the bioequivalence of two cefquinome 2.5% products in piglets. Plasma cefquinome concentrations were analyzed by liquid chromatography-mass spectrometry (LC/MS). Mean maximum concentration ($C_{max}$) of test product ($Cequus^{(R)}$) and reference product ($Cobactan^{(R)}$) were $4.34{\pm}0.58$ and $4.22{\pm}0.47{\mu}g/mL$, and mean area under the concentration time curve ($AUC_{0{\rightarrow}{\infty}}$) values were $10.43{\pm}1.96$ and $10.25{\pm}2.98{\mu}g{\cdot}h/mL$, respectively. The 90% confidence intervals for the ratio of $C_{max}$ (0.941-1.115), and $AUC_{0{\rightarrow}{\infty}}$ (0.927-1.172) values for the test and reference products were within the acceptable bioequivalence limit of 0.80-1.25. It is concluded that two commercial cefquinome injectable solutions are bioequivalent in their extent of drug absorption in piglets.

Comparison of Ga-67, Tl-201 and Tc-99m MIBI Imaging in Lymphoma Patients (림프종 환자에서의 갈륨, Tl-201 그리고 Tc-99m MIBI 섭취의 비교)

  • Chun, Kyung-Ah;Cho, Ihn-Ho;Won, Kyu-Chang;Lee, Kyung-Hee;Lee, Hyung-Woo;Hyun, Myung-Soo;Lee, Jae-Tae;Lee, Kyu-Bo
    • Journal of Yeungnam Medical Science
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    • v.19 no.2
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    • pp.107-115
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    • 2002
  • Purpose: Ga-67 scintigraphy has been used for the evaluation of tumors, especially lymphoma. Recently, Tl-201 and Tc-99m MIBI were also used to tumor imaging. Tl-201 and Tc-99m MIBI had better physiologic characteristics than Ga-67, so we studied 32 biopsy proven lymphoma patients (male 24, female 8, mean age 46 years) with Ga-67, Tl-201 or Tc-99m MIBI and compared the scan findings. Materials and Methods: Twenty-three of 32 patients were injected 74-111 MBq (2-3 mCi) of Tl-201, before chemotherapy and imaged with dual-headed SPECT (Prism 2000, Picker, USA) at 30 minutes after injection. Delayed images were obtained after 3 hr in 8 patients. Twenty seven of 32 patients were injected 740 MBq (20 mCi) of Tc-99m MIBI and imaged at 30 minutes after injection. 111-185 MBq (3-5 mCi) of Ga-67 was injected in 12 patients and imaged at 48 and 72 hours after injection. Twenty eight patients were diagnosed as non-Hodgkin's lymphoma and others were Hodgkin's lymphoma. Results: Twenty patients were positive on Tl-201 scan and 3 patients showed negative findings. One of these 3 patients, Tc-99m MIBI and Ga-67 scan were positive. Twenty two patients were positive on Tc-99m MIBI scan and 5 patients showed negative findings. One of these 5 patients, Tl-201 was positive and 2 were positive on Ga-67 scan. Ten of 12 patients showed positive findings on Ga-67 scan. The sensitivity of these agents were 83.3%, 87.0% and 81.5% for Ga-67, Tl-201 and Tc-99m MIBI, respectively. The sensitivity was highest in Tl-201 scan, but there were no significant differences among three tests. In this study, there was no significant difference of uptake ratios between early and delayed images of Tl-201. Conclusion: Scintigraphy with Tl-201 and Tc-99m MIBI in lymphoma patients have similar sensitivity with Ga-67.

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Skin Improvement Effects and Development of Liposome Capsule Technology Using Centella Asiatica Extract Powder (센텔라아시아티카정량추출물의 리포좀 캡슐기술 개발과 피부개선효과)

  • Kim, Seong Jang;Ju, Yeon Jeong;Kim, In-Young
    • Journal of the Korean Applied Science and Technology
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    • v.37 no.5
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    • pp.1285-1297
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    • 2020
  • In this study, we report the results of a study on the clinical evaluation of wrinkle improvement by developing a method for liposome of high-purity Centella asiatica extract used in pharmaceuticals and cosmetics, and a cream using the same. In order to make Centellasome-10EX stabilizing centella asiatica extract in liposome lamella vesicle, it could be completed using 5% hydrogenated lecithin and 2% sucrose distearate. The appearance of Centellasome-10EX was a creamy form of low viscosity, the color was pale yellow, and the odor had the inherent odor of the raw material. The pH was about 6.12, the specific gravity was 1.09, and the acid value was about 0.35. The content of the main constituents of centella asiatica extract contained in the liposome vesicle contains 10,800 ppm of asiatic acid, 10,900 ppm of asiaticoside, 6,000 ppm of madecasic acid, and 1,600 ppm of madecassoside, and long-term storage. There was no discoloration even at the time, and it was found that the main component remained stable thermodynamically. To mechanistically analyze the structure of the liposome vesicle of Centellasome-10EX, as a result of observation with a transmission electron microscope (Cryo-TEM), the multilayer vesicles are formed and filled with moisture, and there are 10 to 60 multilayers around it. It was confirmed that the liposome lamella vesicle was formed. As a clinical trial (in-vivo) test, the moisturizing effect of centellasome cream after application for 5 weeks was 28.3%, which was significantly increased compared to placebo. The skin elasticity effect was 13.6%, which significantly increased the moisturizing power than the placebo. The effect of improving fine wrinkles around the eyes was improved by 23.52% compared to placebo cream. Through the results of this study, it was possible to study the formulation and manufacturing method for encapsulation and stabilization of the developed Centellasome-10EX in the liposome vesicle. It is expected that the results obtained through clinical research on the wrinkle improvement effect of the cream using this can be widely used to study skin science in the cosmetic industry and to develop high-quality cosmetics with high efficacy.

Development and Validation of an Analytical Method for Determination of Fungicide Benzovindiflupyr in Agricultural Commodities Using LC-MS/MS (LC-MS/MS를 이용한 농산물 중 살균제 벤조빈디플루피르의 잔류시험법 개발 및 검증)

  • Lim, Seung-Hee;Do, Jung-Ah;Park, Shin-Min;Pak, Won-Min;Yoon, Ji Hye;Kim, Ji Young;Chang, Moon-Ik
    • Journal of Food Hygiene and Safety
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    • v.32 no.4
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    • pp.298-305
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    • 2017
  • Benzovindiflupyr is a new pyrazole carboxamide fungicide that inhibits succinate dehydrogenase of mitochondrial respiratory chain. This study was carried out to develop an analytical method for the determination of benzovindiflupyr residues in agricultural commodities using LC-MS/MS. The benzovindiflupyr residues in samples were extracted by using acetonitrile, partitioned with dichloromethane, and then purified with silica solid phase extraction (SPE) cartridge. Correlation coefficient ($r^2$) of benzovindiflupyr standard solution was 0.99 over the calibration ranges ($0.001{\sim}0.5{\mu}g/mL$). Recovery tests were conducted on 5 representative agricultural commodities (mandarin, green pepper, potato, soybean, and hulled rice) to validate the analytical method. The recoveries ranged from 79.3% to 110.0% and then relative standard deviation (RSD) was less than 9.1%. Also the limit of detection (LOD) and limit of quantification (LOQ) were 0.0005 and 0.005 mg/kg, respectively. The recoveries of interlaboratory validation ranged from 83.4% to 117.3% and the coefficient of variation (CV) was 9.0%. All results were followed with Codex guideline (CAC/GL 40) and Ministry of Food and Safety guideline (MFDS, 2016). The proposed new analytical method proved to be accurate, effective, and sensitive for benzovindiflupyr determination and would be used as an official analytical method.

Antioxidant Effects of Stewartia koreana Nakai Leaves and Branch Extracts (노각나무 잎과 가지 추출물의 항산화 효과)

  • Kim, Hye Soo;Park, Min Jeong;Kim, Soo Jeong;Kim, Bu Kyung;Park, JunHo;Kim, DaeHyun;Cho, Soo Jeong
    • Journal of Life Science
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    • v.31 no.2
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    • pp.229-236
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    • 2021
  • This study was carried out to evaluate the antioxidant properties of the dried leaves and branches of Stewartia koreana Nakai. The dried leaf and branch of S. koreana were extracted with 70% ethanol at 80℃. The antioxidant activities of ethanol extracts of S. koreana leaf (EESL) and S. koreana branch (EESB) were analyzed. The total polyphenol contents in EESL and EESB were 162.57±0.9 mg of GAEs/extract g and 59.1±0.9 mg of GAEs/extract g, respectively. The flavonoid contents in EESL and EESB were 59.1±0.9 mg of QEs/extract g and 4.7±0.1 mg of QEs/extract g, respectively. EESL showed a better scavenging ability with DPPH and ABTS than EESB, at 0.4 mg/ml. Moreover, EESL were more effective according to ORAC values than EESL. The toxicity of EESL was investigated using a WST-1 assay on the human skin fibroblast cell line CCD-986sk. Therefore, EESL can be used as a potential source of functional, naturally-sourced material in cosmetics as well as food.

A study of analytical method for Benzo[a]pyrene in edible oils (식용유지 중 벤조피렌 분석법 비교 연구)

  • Min-Jeong Kim;jun-Young Park;Min-Ju Kim;Eun-Young Jo;Mi-Young Park;Nan-Sook Han;Sook-Nam Hwang
    • Analytical Science and Technology
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    • v.36 no.6
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    • pp.291-299
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    • 2023
  • The benzo[a]pyrene in edible oils is extracted using methods such as Liquid-liquid, soxhlet and ultrasound-assisted extraction. However these extraction methods have significant drawbacks, such as long extraction time and large amount of solvent usage. To overcome these drawbacks, this study attempted to improve the current complex benzo[a]pyrene analysis method by applying the QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) method that can be analyzed in a simple and short time. The QuEChERS method applied in this study includes extraction of benzo[a]pyrene into n-hexane saturated acetonitrile and n-hexane. After extraction and distribution using magnesium sulfate and sodium chloride, benzo[a]pyrene is analyzed by liquid chromatography with fluorescence detector (LC/FLR). As a result of method validation of the new method, the limit of detection (LOD) and quantification (LOQ) were 0.02 ㎍/kg and 0.05 ㎍/kg, respectively. The calibration curves were constructed using five levels (0.1~10 ㎍/kg) and coefficient (R2) was above 0.99. Mean recovery ratio was ranged from 74.5 to 79.3 % with a relative standard deviation (RSD) between 0.52 to 1.58 %. The accuracy and precision were 72.6~79.4 % and 0.14~7.20 %, respectively. All results satisfied the criteria ranges requested in the Food Safety Evaluation Department guidelines (2016) and AOAC official method of analysis (2023). Therefore, the analysis method presented in this study was a relatively simple pretreatment method compared to the existing analysis method, which reduced the analysis time and solvent use to 92 % and 96 %, respectively.

Analysis of Aminoglycoside Antibiotics in Meat and Cell Culture Medium Coupled with Direct Injection of an Ion-pairing Reagent (이온쌍 시약 직접 주입법을 활용한 육류 및 세포배양액 내 아미노글리코사이드계 항생제 분석)

  • Kyung-Ho Park;Song-Yi Gu;Geon-Woo Park;Jong-Jib Kim;Jong-soo Lee;Sang-Gu Kim;Sang-Yun Lee;Hyang Sook Chun
    • Journal of Food Hygiene and Safety
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    • v.38 no.5
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    • pp.319-331
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    • 2023
  • Aminoglycoside antibiotics, also known as aminoglycosides (AGs), are veterinary drugs effective against a wide range of gram-negative and gram-positive bacteria. Owing to their recent use in cultured meats, it has become essential to establish an analytical method for safety management. AGs are highly polar compounds, and ion-pair reagents (IPRs) are used to ensure component separation. Owing to the high possibility of potential mechanical problems resulting from IPR addition to the mobile phase, an analytical method in which IPRs are added directly to the vial was explored. In this study, methods for analyzing 10 AGs via liquid chromatography-tandem mass spectrometry (LC-MS/MS) with the addition of two IPRs were validated for selectivity, detection limit, quantitation limit, recovery, and precision. The detection limit was 0.0001-0.0038 mg/kg, the quantification limit was 0.004-0.011 mg/kg, and the linearity (R2) within the concentration range of 0.01-0.5 mg/kg was over 0.99. Recovery and precision (expressed as relative standard deviation) evaluated in the two matrices (beef and cell culture media) ranged from 70.7% to 120.6% and 0.2% to 24.7%, respectively. The validated AG analytical method was then applied to 15 meats prepared from chicken, beef, and pork, and 6 culture media and additives used in cultured meat. No AGs were detected in any of the 15 meats distributed in Korea; however, streptomycin and dihydrostreptomycin were detected at levels ranging from 695.85 to 1152.71 mg/kg and 6.35 to 11.11 mg/kg, respectively, in the culture media additives. The LC-MS/MS method coupled with direct addition of IPRs to the vial can provide useful basic data for AG analysis and safety evaluation of meats as well as culture media and additives for cultured meats.

Evaluation of Liver Function Using $^{99m}-Lactosylated$ Serum Albumin Liver Scintigraphy in Rat with Acute Hepatic Injury Induced by Dimethylnitrosamine (Dimethylnitrosamine 유발 급성 간 손상 흰쥐에서 $^{99m}-Lactosylated$ Serum Albumin을 이용한 간 기능의 평가)

  • Jeong, Shin-Young;Seo, Myung-Rang;Yoo, Jeong-Ah;Bae, Jin-Ho;Ahn, Byeong-Cheol;Hwang, Jae-Seok;Jeong, Jae-Min;Ha, Jeong-Hee;Lee, Kyu-Bo;Lee, Jae-Tae
    • The Korean Journal of Nuclear Medicine
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    • v.37 no.6
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    • pp.418-427
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    • 2003
  • Objects: $^{99m}-lactosylated$ human serum albumin (LSA) is a newly synthesized radiopharmaceutical that binds to asialoglycoprotein receptors, which are specifically presented on the hepatocyte membrane. Hepatic uptake and blood clearance of LSA were evaluated in rat with acute hepatic injury induced by dimethylnitrosamine (DMN) and results were compared with corresponding findings of liver enzyme profile and these of histologic changes. Materials and Methods: DMN (27 mg/kg) was injected intraperitoneally in Sprague-Dawley rat to induce acute hepatic injury. At 3(DMN-3), 8(DMN-8), and 21 (DMN-21) days after injection of DMN, LSA injected intravenously, and dynamic images of the liver and heart were recorded for 30 minutes. Time-activity curves of the heart and liver were generated from regions of interest drawn over liver and heart area. Degree of hepatic uptake and blood clearance of LSA were evaluated with visual interpretation and semiquantitative analysis using parameters (receptor index : LHL3 and index of blood clearance : HH3), analysis of time-activity curve was also performed with curve fitting using Prism program. Results: Visual assessment of LSA images revealed decreased hepatic uptake in DMN treated rat, compared to control group. In semiquantitative analysis, LHL3 was significantly lower in DMN treated rat group than control rat group (DMN-3: 0.842, DMN-8: 0.898, DMN-21: 0.91, Control: 0.96, p<0.05), whereas HH3 was significantly higher than control rat group (DMN-3: 0.731,.DMN-8: 0.654, DMN-21: 0.604, Control: 0.473, p<0.05). AST and ALT were significantly higher in DMN-3 group than those of control group. Centrilobular necrosis and infiltration of inflammatory cells were most prominent in DMN-3 group, and were decreased over time. Conclusion: The degree of hepatic uptake of LSA was inversely correlated with liver transaminase and degree of histologic liver injury in rat with acute hepatic injury.

Health Management and Services of School-Nurse in Special Schools (특수학교의 보건관리)

  • Lee, Kyung Hee;Park, Jae Yong
    • Journal of the Korean Society of School Health
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    • v.4 no.2
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    • pp.176-192
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    • 1991
  • School nurses, in service of 102 special schools in Korea, were urveyed by mail questionnaires from February to March, 1991 and 77 of hem responded. Collected data were analyzed to establish the direction of health management in special school and to provide basic reference data for improving the quality of the management of school-nurses' services. The major findings are as follows: Out of special schools surveyed, 67.5% is private school and 83.2% is located in city. The average number of classes, students, and educational personnels per special school is 17.2, 194, and 28 respectively. The average age of school-nurses surveyed is 32.7. The proportion of graduates from the junior college and upward was 97.4%, the proportion of the married was 71.4%. Out of respondents, 71.4% has religion : 79.2% has past career in the fields of clinics or public health: 62.3% accompanishes independent services: 77.9% belongs to primary school. About 69% of nursing room in special schools surveyed is located at the first floor. Out of special school surveyed, 90.9% has no organization for school health programms: Only 18.2% entrusted everyone of school doctor, school dentist, and school pharmacists with school health. 46.8% of respondents didn't know about the annual budget for school health programmes. The average annual expenditure for school health programme per special school was 317,000F26. won and the purchase cost for medical supplies accounted for the larger part of them. The monthly average number of students utilizing school nursing room was 71 per school, annual utilization times of school nursing room was 4.4 per student and utilization due to injury was prevalent by 26.6% and there is some differences in using the school nursing room according to disabled area. Rate of referral to medical facilities was 1.4%. The leading reason of referral to medical facilities was high fever among those who have visual handicaps, fracture among those who have emotional disturbance, injury by trauma among others. Nine hundred fifty six students of students in special school surveyed have sufferd from epilepsy and prevalence rate of epilepsy was 6.4%. Only 22.6% of respondents replied that they had physical examination more than 2 times per year. Out of respnodents, 98.7% answered that they had health education and 67.1% of them ansered that they educated in a classroom, 98.7% of respondents emphasized need of sex education. Respondents put the most emphasis on the personal hygiene when they performed health education and they used broadcasting education in the area of visual handicaps, OHP or VTR in hearing handicaps, home correspondence or OHP VTR in other area importantly. About 47% of repondents answered that health education was the most difficult and they emphasized that definite guide on health management was requested. Respondents had self-confidence and high perfomance rate in most of school-nurses' services completely, but so they was not in area of evaluation of school health programmes, an examination of physical strength, evaluation of health education, management of school purification area, suture of wounds. In consideration of above findings, we may conclude that special education for school-nurse in special schools as well as improvement of definite guiding principles are requested to establish direction for health management in special schools and to improve the degree of quality for school-nurses' sevices in special schools.

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Biological Activity of Sorghum bicolor M. cv. Bulgeunjangmoksusu Extracts (붉은장목수수 추출물의 생리활성)

  • Kim, Joo-Seok;Lee, Yea-Ji;Yang, Jinfeng;Sa, Yeo-Jin;Kim, Myeong-Ok;Park, Jong-Hyuk;Park, Dong-Sik;Yu, Chang-Yeon;Kim, Myong-Jo
    • Korean Journal of Plant Resources
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    • v.26 no.1
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    • pp.111-118
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    • 2013
  • The objective of this study was to determine the biological activities of Sorglum bicolor extracts. Organic fractions, including n-Hexane, EtOAc, and n-BuOH fractions were obtained from the methanol extract of Sorglum bicolor M.. In DPPH radical scavenging activity, $SC_{50}$ values of methanol extract and EtOAc fraction were exhibited $0.66{\pm}0.26{\mu}g/mL$ and $1.03{\pm}0.02{\mu}g/mL$, respectively. Contents of total polyphenol and flavonoids in EtOAc fraction, which were much higher than those of other fractions, were 58.12 mg/g and 4.79 mg/g respectively. Also, effects of reducing power was strongly showed in EtOAc fraction. ${\alpha}$-Glucosidase and ${\alpha}$-amlyase inhibition activities were showed the higher effect in D.W. fraction ($2.83{\mu}g/mL$, $36.64{\mu}g/mL$). In MTT assay in the AGS, HT29 and HCT116 cell lines were significantly higher in the n-BuOH fraction than in the other fractions at $50{\mu}g/mL$ concentration of extracts.