• Journal of the Korea Institute of Military Science and Technology
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• v.24 no.3
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• pp.348-355
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• 2021

Hantaan virus(HTNV) causes hemorrhagic fever with renal syndrome(HFRS) with a case fatality rate ranging from <1 to 15 % in human. Hantavax^Ⓡ is a vaccine against the Hantavirus, which has been conditionally approved by the Ministry of Food and Drug Safety(MFDS). However, only 50 % of volunteers had neutralizing antibodies 1 year following the boost. Effective antiviral treatments against HTNV infection are limited. Hantaviruses generally cause asymptomatic infection in adult mice. On the other hand, infection of suckling and newborn mice with hantaviruses causes lethal neurological diesease or persistant infection, which is different from the disease in humans. The development of vaccines and antiviral strategies for HTNV has been partly hampered by the lack of an efficient lethal mouse model to evaluate the efficacy of the candidate vaccines or antivirals. In this report, we established a lethal mouse model for HTNV, which may facilitate in vivo studies on the evaluation of candidate drugs against HTNV. The median lethal dose value of HTNV was calculated by probit analysis of deaths occurring within two weeks. Five groups of ten ICR mice were injected intracranially with serial 2-fold dilutions (from 50 to 3.125 PFU/head) of HTNV. Mice injected with HTNV began to die at 8 days post-infection. The lethal dose required to kill 50 % of the mice (LD₅₀) was calculated to be 2.365 PFU/head.

• Pediatric Infection and Vaccine
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• v.23 no.2
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• pp.117-127
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• 2016

Purpose: Vaccine evaluation studies were initiated from 2000 by the Ministry of Food and Drug Safety to produce proper data about the safety and immunogenicity of vaccines. The purpose of this study was to review studies and reports on evaluation of vaccine such as immunogenicity, efficacy, effectiveness, safety and other related topics in order to find and analyze the data on the usefulness of each vaccine. Methods: From 2000 to 2014, the project "The vaccine evaluation" had been performed by several researchers, and studies and reports of vaccine evaluation. We reviewed the results and outcomes of studies regarding the evaluation of vaccine's usefulness and analyzed the possibilities of applying these data for establishing vaccine policies. For each vaccine, data analysis and organization were done according to evaluation fields. Results: A total of 83 studies were performed on vaccines from 2000 to 2014. For each vaccine, 8 studies were performed on BCG, 14 on DTaP/Td, 1 on poliovirus, 5 on Hib, 3 on pneumococcus, 11 on influenza, 3 on hepatitis A, 11 on MMR, 11 on varicella, and 16 on Japanese encephalitis. All studies were analyzed by the following evaluation area, such as safety, immunogenicity, seroprevalence, persistence of immunity, efficacy, effectiveness, vaccine evaluation methods, quality control product for vaccine, and others. Conclusions: Vaccine evaluation studies performed in Korea may be useful as references for establishing vaccination strategy and policy and could be used as baseline data for future studies on vaccine evaluation, vaccine policy establishment, and public/expert vaccine education in Korea.

• The Korea Journal of Herbology
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• v.37 no.5
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• pp.9-16
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• 2022

Objectives : The purpose of this study is to report that applying the genetic discrimination method to Pinelliae Tuber is suitable as a countermeasure for the limitations of morphological identification announced publicly in the Ministry of Food and Drug Safety(MFDS). Methods : Randomly selected fifty samples in Pinelliae Tuber imported from China were used for morphological and genetic identification. The morphological identification was applied method announced publicly by the MFDS. The traits of morphological identification were classified as Pinellia ternata, P. tripartita, Pinellia pedatisecta, and Typhonium flagelliforme, according to the formation of tuberous root and tuber morphology. The genetic identifications were conducted by Sequence Characterized Amplified Region(SCAR) marker and DNA barcoding analysis for cross-validation, respectively. SCAR marker was verified according to the presence or absence of amplicon through PCR amplification using species-specific primers. DNA barcoding analysis used sequence information of the matK region. Results : As a result of the morphological identification, 27 out of 50 samples were identified as original species 'P. ternata' of genuine 'Pinelliae Tuber', and 23 were identified as adulterant species 'P. pedatisecta'. Unlike this, the genetic identification was identified as the original species 'P. ternata' in all 50 samples in the SCAR marker and matK regional sequence analysis. Conclusions : Pinelliae Tuber of morphological mutant that can not be classified by morphological identification is imported from China. The SCAR marker would be used as accurate and efficient assays for species identification of the morphological mutant.

• Korean journal of food and cookery science
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• v.31 no.5
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• pp.534-543
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• 2015

Recently, the Tenebrio molitor larva was recognized as a novel food ingredient by the Ministry of Food and Drug Safety in Korea. Accordingly, we investigated its physical and sensory characteristics to establish the cooking conditions that may increase the demand of T. molitor larvae as a food. In this study, T. molitor larvae were cooked by various methods such as hot air dry, oven-broil, roast, pan fry, deep fry, boil, steam, and by microwave. In the physical evaluation of texture, the hardness and fracturability values were highest when larvae were cooked in the microwave. The adhesiveness, springiness, and chewiness values were highest when larvae were boiled. Boiled and steamed larvae had the highest lightness (L value), while oven-broiled larvae had the highest redness (a value) and yellowness (b value) values. Sensory evaluations assessed the appearance, aroma, flavor, and texture of cooked T. molitor larvae. Steamed and boiled larvae sizes were significantly large and the form was well preserved similar to fresh larvae. The moisture heat cooked (steamed and boiled) T. molitor larvae had the aroma and flavor of steamed corn, canned pupa, and boiled mushroom. In case of oven-broiled T. molitor larvae, the aroma and flavor of mealworm oil, seafood, sweet and roasted sesame were higher than in those cooked by other methods. In texture among sensory evaluation, the hardness and crispiness were the highest in the hot air dried and oven-broiled larvae, whereas juiciness was significantly higher in the boiled and steamed. Accordingly, we suggest that oven-broiled T. molitor larva will be prefered by consumer, due to its the rich aroma and flavor.

• Parasites, Hosts and Diseases
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• v.53 no.4
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• pp.455-463
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• 2015

The present study was performed to compare the mitochondrial genomes between 2 Spirometra tapeworms, Spirometra erinaceieuropaei and Spirometra decipiens (Cestoidea: Diphyllobothriidae), which larval stages are important etiological agents of sparganosis in humans. For each species, the full mitochondrial genome was amplified in 8 overlapping fragments using total genomic DNA purified from a single worm as the template. The mitochondrial genomes were 13,643 bp (S. erinaceieuropaei) and 13,641 bp (S. decipiens) in length and contained 36 genes; 12 protein-coding genes, 2 ribosomal RNA (rRNA, small and large subunits), and 22 transfer RNAs (tRNAs). The 12 protein-coding genes constituted 10,083 bp (S. erinaceieuropaei) and 10,086 bp (S. decipiens) of their respective mitochondrial genomes. The tRNA genes, ranging in length from 56 to 70 bp, were identified based on putative secondary structures such as the typical cloverleaf shape. A total of 23 intergenic sequences, varying from 1 to 204 bp in size, were interspersed in S. erinaceieuropaei (total, 504 bp) and S. decipiens (total, 496 bp) mtDNA. The 12 protein-coding genes of S. erinaceieuropaei and S. decipiens differed by 12.4%, whereas the overall difference in mtDNA sequence between S. erinaceieuropaei and S. decipiens was 12.9%. Thus, from the standpoint of the mitochondrial genome, S. decipiens represents a valid species that can be distinguished from S. erinaceieuropaei.

• Journal of Society of Preventive Korean Medicine
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• v.24 no.2
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• pp.43-55
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• 2020

Objectives : The general and specific characteristics inherited in Korean traditional medicine research is to be identified and on the basis of this, the role of researchers, research institutes and government organizations is to be presented. Method : Analysis data targeted 399 cases of traditional medicine researches out of 696 cases, excluding overlapped 297 cases, that are relevanttokey-words, 'Oriental Medicine' and 'Herbal Prescription' registered in the National Institutes of Health Clinical Research Information Service(CRIS) as of 31 December, 2019. Including the regulation of the Ministry of Food and Drug Safety, research fund supporting, type of mediation, targeting disease and so forth, frequency analysis was carried out in order to confirm the general and specific characteristics of traditional medicine. Results : As a result of analyzing the data, researches of medicines(herbal medicines) and mediation(acupuncture, moxibustion) and were identified as the most and in the case of the targeting disease, it appeared in the order of targeting the research on musculoskeletal system and the healthy person.

• Korean Journal of Poultry Science
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• v.43 no.4
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• pp.235-242
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• 2016

This study was conducted to investigate the microbiological sanitation status of raw chicken meat distributed in Korea, and potential changes in chicken breast quality during storage. The microbiological sanitation status analysis of raw chicken involved studying the results of microbiological monitoring for a 5-year period (2010~2014) by the Korean Food and Drug Administration. Furthermore, the microbiological status of raw chicken meat in meat packing centers and shops in Seoul/Gyeonggi, Kangwon, and Chungcheong Provinces was investigated from July to August 2015. The total bacterial counts of chicken meat in the packaging centers and meat shop of these Provinces were below the level specified in the Korean Meat Microbiological Guideline ($1{\times}10^7$ colony forming units [CFU]/g) and showed a similar microbiological sanitation status with results of the microbiological monitoring for the analyzed 5-year period. To evaluate the relationship between quality change and microbiological level of the meat distributed in Korea, the pH and microbiological and sensory quality characteristics of the chicken breast samples during storage at $4{\pm}2^{\circ}C$were determined. On day 4, the total bacterial count of the chicken breast was 6.76 log CFU/g, which was close to the official $1{\times}10^7CFU/g$ standard, the pH was 5.96, and the overall acceptability was reduced significantly (p<0.05). In particular, the aroma score was <5, indicating that the consumer panel expressed a negative perception even though the chicken contained a lower microbial level than that specified in the Korean microbiological guideline. These results suggest that the current Korean microbiological guideline for raw chicken meat may require a stricter level of up to $1{\times}10^6CFU/g$ to satisfy both meat safety standards and organoleptic quality for consumers.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.41-52
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• 2023

With the international change in the medical device market owing to the development of innovative medical engineering and the use of various raw materials, a systematic and rational medical device classification system is needed to safely manage newly developed medical devices. This study aims to improve the domestic medical device classification system by proposing product establishment and segmentation. It is based on medical device products from the United States and Europe that are only available in foreign systems and are more subdivided than domestic products. This study analyzes and compares the domestic and foreign medical device classification systems by examining laws, guidelines, and analysis reports in Korea, the United States, and Europe. In accordance with product establishment and segmentation criteria, products subject to improvement are presented. This study contributes to safely managing medical devices that do not fit with the current classification system and to solving the confusion caused by the lack of international harmony in product classification systems.

• Herbal Formula Science
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• v.32 no.3
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• pp.277-296
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• 2024

Objective : Dyspepsia is one of the most common ailments among Koreans, leading to a continuously expanding market for liquid digestive solutions. These products are popular due to their convenience and low risk of side effects. However, there is a lack of research on the basic prescription composition of these ingredients and their precise indications according to Korean Medicine. Methods : Drugs were selected from the Korea Pharmaceutical Information Service website (http://www.health.kr), focusing on oral and liquid products classified under the Ministry of Food and Drug Safety's category of stomach and digestive aids (category 233). Frequency analysis was conducted to determine the occurrence and combinations of herbal ingredients within each product. Additionally, the four properties and five flavors of each product were calculated using their herbal ingredient composition ratios, and Pearson correlation coefficients were employed to verify the linear relationships between the composition ratios of the ingredients. Results : A comparative analysis of 33 liquid digestive medicines revealed that Zingiberis Rhizoma was the most frequently used herb. The most common dual-herb combination was Zingiberis Rhizoma and Citri Unshius Pericarpium, and the most prevalent tri-herb combination was Zingiberis Rhizoma, Citri Unshius Pericarpium, and Cinnamomi Cortex. Pearson correlation coefficient analysis showed a strong positive correlation between the composition ratios of Zingiberis Rhizoma and Cinnamomi Cortex. The analysis of four properties and five flavors indicated that products with warm and bitter flavors were the most common. Conclusions : The most frequently used herbal combination in liquid digestive solutions was Zingiberis Rhizoma, Citri Unshius Pericarpium, and Cinnamomi Cortex. This composition is suitable for treating dyspepsia caused by cold-dampness in the digestive system.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.21 no.3
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• pp.137-146
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• 2020

Syrup agents are often used after opening, and therefore, there is a high possibility of decreased quality. The Ministry of Food and Drug Safety (MFDS) published guideline on stability testing for pharmaceuticals after opening in December, 2016. We compared guidelines related to the period of use after opening between the United States of America (USA), Europe (EU), and Korea, and we analyzed whether the period of use or storage conditions is stated based on the data of drug approval for 4 dry syrups and 3 large packing syrups before and after the introduction of the guideline. First, in USA and EU, the period of use and storage conditions after opening should be listed on the label on the packaging container (as well as the expiration date), while in Korea, those are included in the area of precautions for use. Second, all of the analyzed drugs were not changed by the guidelines for establishing the new post-opening period of use, and they were only presented for the existing expiration date prior to the establishment of the guideline. Medicines that are used for multiple uses after opening may need improved instructions to ensure that the period of use and storage conditions are listed on the packaging according to stability evaluation after opening.