• Title/Summary/Keyword: safety examination

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Single-dose Intramuscular Injection Toxicology of Danggui Pharmacopuncture (DGP) in Sprague-Dawley Rats

  • Sun, SeungHo;Jeong, JongJin;Park, Sunju;Lee, KwangHo;Yu, JunSang;Seo, Hyung-Sik;Kwon, KiRok
    • Journal of Pharmacopuncture
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    • v.18 no.1
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    • pp.56-62
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    • 2015
  • Objectives: The purpose of the study is to assess both the approximate lethal dose and the single dose intramuscular injection toxicity of Danggui (Angelica gigantis radix) pharmacopuncture (DGP) in Sprague-Dawley (SD) rats. Methods: The experiments were conducted at the good laboratory practice (GLP) laboratory, Biotoxtech Co., which is a laboratory approved by the ministry of food and drug safety (MFDS). The study was performed according to the GLP regulation and the toxicity test guidelines of the MFDS (2009) after approval of the institutional animal care and use committee of Biotoxtech. Single doses of DGP were injected intramuscularly into the rats in three test groups of 6 week old SD rats (5 male and 5 female rats per groups) in the amounts of 0.1, 0.5, and 1.0 mL/animal for groups 2, 3, and 4, respectively, and normal saline solution in the amount of 1.0 mL/animal was injected intramuscularly into the rats (5 male and 5 female rats) in the control group. Observations of the general symptoms and weight measurements were performed during the 14 day observation period after the injection. Hematologic and serum biochemical examination, necropsy, and a local tolerance test at the injection site were done after the observation period. Results: No death was observed in three test groups (0.1, 0.5 and 1.0 mL/animal group). In addition, the injection of DGP had no effect on general symptoms, weights, hematologic and serum biochemical examination, and necropsy. The results from the local tolerance tests at injection site showed no treatment related effects in the SD rats. Conclusion: The results of single dose intramuscular injection of DGP suggest that the approximate lethal dose is above 1.0 mL/animal for both male and female SD rats and that intramuscular injection of DGP may be safe.

Surface Dose Evaluation According to the Environment Around the Patient after Nuclear Medicine Examination (핵의학 검사 후 환자의 주위 환경에 따른 표면 선량 평가)

  • Lee, Young-Hee;Park, Jae-Yoon
    • Journal of the Korean Society of Radiology
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    • v.15 no.7
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    • pp.943-948
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    • 2021
  • The purpose of this study was to investigate changes in surface dose due to increased scattering of gamma rays from patients injected with 99mTc and 18F, which are radioactive isotopes, in close contact with materials with high atomic number such as the walls of the stable room. Prepare 99mTc and 18F by injecting 20 and 10 mCi respectively into the NEMA phantom, and then measuring the surface dose for 60 minutes by positioning the phantom at a height of 1 m above the surface, at a distance of 0, 5 and 10 cm from the wall, and at the same location as the phantom facing the wall. Each experiment was repeated five times for reproducibility of the experiment and one way analysis of variability (ANOVA) was performed for significance testing and Tukey was used as a post-test. The study found that surface doses of 220.268, 287.121, 243.957, and 226.272 mGy were measured at 99mTc, respectively, in the case of empty space and in the case of 0, 5 and 10 cm, while those of 18F were measured at 637.111, 724.469, 657.107, and 640.365 mGy, respectively. In order to reduce changes in surface dose depending on the patient's location while waiting, it is necessary to keep the distance from the ground or the wall where the patient is closely adhered to, or install an air mattress, etc., to prevent the scattered lines as much as possible, considering the scattered lines due to the wall etc. in future setup of the patient waiting room and safety room, and in addition to the examination, the external skin width may be reduced.

Effects of Sunbanghwalmyung-Eum Gamibang on MIA-Induced Osteoarthritis in Rats (흰쥐에서 MIA로 유발된 골관절염에 선방활명음 가미방이 미치는 영향)

  • You Bin, Shin;Han Byeol, Park;Jae Su, Kim;Hyun Jong, Lee;Sung Chul, Lim;Yun Kyu, Lee
    • Korean Journal of Acupuncture
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    • v.39 no.4
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    • pp.152-171
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    • 2022
  • Objectives : This study was designed to investigate the effects of Sunbanghwalmyung-eum gamibang on Monosodium iodoacetate-induced osteoarthritis rats. Methods : Forty Sprague-Dawley (SD) rats were divided into 5 groups of 8 rats each. Osteoarthritis (OA) was induced by injecting MIA (2 mg/50 µl) into the joint cavity of the left knee of SD rats belonging to the experimental group, and normal saline was injected into the joint cavity of the left knee instead of MIA in the normal group. To the normal group and the controlled group (OA group), 2 ml of distilled water was orally administered. To the positive control group (Indomethacin group), indomethacin 2 ml at a concentration of 2 mg/kg, to the low concentration group of SHG (Low group), 2 ml of SHG at a concentration of 2 mg/kg, and to the high concentration group of SHG (High group), 2 ml of SHG at a concentration of 4 mg/kg ml was orally administered. The drug was administered for a total of 4 weeks, and histological changes were analyzed by Hematoxylin-Eosin staining and Safranin-O staining. In addition, inflammatory cytokines such as TNF-α, IL-1β, and IL-6, and MMP-13, TIMP-1, and GAGs were immunohistochemically analyzed. Finally, hematological examination, blood biochemical examination, and liver and kidney biopsy were performed. Results : SHG groups (Low and High) inhibited the matrix destruction and damage of the knee joint cartilage in SD rat model, and significantly prevented the reduction in cartilage thickness. In SHG groups, the expressions of TNF-α, IL-1β, IL-6 and MMP-13 were significantly decreased, and the expressions of TIMP-1, GAGs were significantly increased compared with OA group. The safety indicators had no significant differences among five groups. Conclusions : These results show that SHG has cartilage protection capacity, anti-inflammatory effect.

Development and Research on a Functional Hydrolyzed Whey Protein Powder Product with Sialic Acid as a Marker Compound - II. Repeated 90-day Oral Administration Toxicity Test using Rats Administered Whey Protein Powder containing Highly Concentrated Sialic Acid (23%) produced by Enzyme Separation and Solvent Enrichment Method - (Sialic Acid를 지표성분으로 하는 유청가수분해단백분말의 기능성식품 개발연구 - II. 효소분리 용매정제로 고농도 Sialic Acid가 함유된 유청가수분해단백분말(23%)의 랫드를 이용한 90일 반복경구투여 독성시험 평가 연구 -)

  • Noh, Hye-Ji;Cho, Hyang-Hyun;Kim, Hee-Kyong;Koh, Hong-Bum
    • Journal of Dairy Science and Biotechnology
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    • v.34 no.2
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    • pp.117-135
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    • 2016
  • The present study was performed to develop a functional raw food material from hydrolyzed whey protein powder (23%-GNANA) medication containing sialic acid as a marker compound that is naturally occurring at 7% concentration in GMP (glycomacropeptide). GMP is used worldwide in foodstuffs for babies and infants and is obtained from the milk protein as safe food. While the purpose of our detailed evaluation was aimed to assess preliminary NOAEL values for and above 2,000 mg/kg/day, a clinical dose allowance for 23%-GNANA (as per characteristic of a functional health product, a highly refined test substance of 23% (v/v) sialic acid combined in GMP), at the same time we also wanted to assess the safety of GMP hydrolyzate lacking sialic acid but with identical properties as GMP. Animal safety evaluation was conducted using 23%-GNANA as the test substance, produced from hydrolyzed whey protein powder (product name: HELICOBACTROL-23; provided by Medinutrol Inc. [Korea]; composed of 23% sialic acid and GMP protein) after isolating the sialic acid using enzymes approved as food additives, with GMP as a raw material, and subsequently increasing the content of xx up to 23% through 80% (v/v) ethanol soaking and concentrating, in accordance with GLP Guideline. The animal safety evaluation mentioned above was made on the basis of toxicity in SPF Sprague-Dawley female and male rats dosed with 10 mL of the test substance diluted to 0, 1,250, 2,500, and 5,000 mg/kg directly into their stomachs for 90 d. This was determined in terms of the general symptoms and animal viability, weight and amount of feed intake, eye examination, uracrasia tests, hematological and blood biochemical disorder tests, blood coagulation test, abnormal intestine weight, abnormalities during postmortem and histopathological examinations. Statistical significance was set at P<0.05. Based on the toxicity determination, a certain minor effect associated with the test substance was observed in male rats with no major effects of the tested substance, in comparison with the control group dosed with sterilized water. Nevertheless, the NOAEL value, evaluated as per toxicity criteria, was verified as 5,000 mg/kg/day (P<0.05). Similarly, for female rats, a certain minor effect associated with the test substance was observed in 5,000 mg/kg/day dosed group, with no major effect, yet the NOAEL value (as assessed as per toxicity criteria) was determined to be 5,000 mg/kg/day (P<0.05), which was the same as for male rats. Accordingly, the NOAEL values of the test substances for all female and male rats were finally verified as 5,000 mg/kg/day (P<0.05). In conclusion, it was determined that the 23%-GNANA test substance exceeds 2,000 mg/kg/day, the clinical allowance characteristic for functional health food, and was finally evaluated to cause no safety concerns when used as a raw material in functional health food production, which was the ultimate goal of the present study.

Development and Validation of the 'Food Safety and Health' Workbook for High School (고등학교 「식품안전과 건강」 워크북 개발 및 타당도 검증)

  • Park, Mi Jeong;Jung, Lan-Hee;Yu, Nan Sook;Choi, Seong-Youn
    • Journal of Korean Home Economics Education Association
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    • v.34 no.1
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    • pp.59-80
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    • 2022
  • The purpose of this study was to develop a workbook that can support the class and evaluation of the subject, 「Food safety and health」 and to verify its validity. The development direction of the workbook was set by analyzing the 「Food safety and health」 curriculum, dietary education materials, and previous studies related to the workbook, and the overall structure was designed by deriving the activity ideas for each area. Based on this, the draft was developed, and the draft went through several rounds of cross-review by the authors and the examination and revision by the Ministry of Food and Drug Safety, before the final edited version was developed. The workbook was finalized with corrections and enhancements based on the advice of 9 experts and 44 home economics teachers. The workbook consists of 4 areas: the 'food selection' area, with 10 learning topics and 36 lessons, the 'food poisoning and food management' area, with 10 learning topics and 36 lessons, the 'cooking' area, with 11 learning topics and 43 lessons, and the 'healthy eating' area, with 11 learning topics and 55 lessons, resulting in a total of 42 learning topics, 170 lessons. The workbook was designed to evenly cultivate practical problem-solving competency, self-reliance capacity, creative thinking capacity, and community capacity. In-depth inquiry-learning is conducted on the content, and the context is structured so that self-diagnosis can be made through evaluation. According to the validity test of the workbook, it was evaluated to be very appropriate for encouraging student-participatory classes and evaluations, and to create a class atmosphere that promotes inquiry by strengthening experiments and practices. In the current situation where the high school credit system is implemented and individual students' learning options are emphasized, the results of this study is expected to help expand the scope of home economics-based elective courses and contribute to realizing student-led classrooms with a focus on inquiry.

The Effect of Seminal Plasma on Chilling and Freezing of Canine Spermatozoa (개 정액의 정장이 개정자의 냉각과 동결에 미치는 영향)

  • You, Myung-Jo;Lee, John-Hwa;Kim, In-Shik;Park, Jin-Ho;Kwon, Jung-Kee;Kim, Jong-Hoon;Kim, Bum-Seok;Yu, Il-Jeoung
    • Journal of Veterinary Clinics
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    • v.24 no.4
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    • pp.486-492
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    • 2007
  • Seminal plasma(SP) is usually removed from semen that is to be cryopreserved. However, some reports indicate that SP has beneficial effects on spermatozoa during chilling and freezing. The purpose of this study was to determine the effect of SP on sperm survival by adding SP to the extender before cooling and freezing canine spermatozoa. In replicate experiments, ejaculates obtained from four healthy dogs(1-4 years old) of various breeds were pooled, centrifuged at $300{\times}g$ for 10 min at $25^{\circ}C$, and the supernatant of seminal plasma was decanted. Spermatozoa were suspended in egg yolk-Tris(EYT) buffer. The study comprised two experiments: [Exp 1] Sperm were suspended in EYT extender containing either 0, 20, 40, 80 or 100% SP and were slowly cooled to $4^{\circ}C$ for 2h or held at $25^{\circ}C$ as controls. Sperm concentration was adjusted to $2{\times}10^8/ml$. [Exp II] Sperm samples, each of which contained $1{\times}10^8/ml$, were assigned to nine groups to be frozen. In the first four groups, sperm in EYT containing either 20, 40, 80 or 100% SP were cooled to $4^{\circ}C$, then diluted to contain final concentrations of EYT+0.6M glycerol and then were frozen. The final concentrations of SP were 10, 20, 40 or 50%. In the other four groups, sperm in EYT alone were first cooled slowly to $4^{\circ}C$, then diluted to contain final concentrations of EYT+0.6M glycerol plus 10, 20, 40 or 50% SP and then were frozen. Spermatozoa, which chilled in EYT alone and diluted to contain final concentrations of EYT+0.6M glycerol without seminal plasma, and then frozen, was regarded as control. Spermatozoa were frozen at $25^{\circ}C/min$ of cooling rate in plastic straws that were suspended above liquid nitrogen and thawed in water at $38^{\circ}C$ for 1 min. Sperm survival was assayed by determining progressive motility and integrity of plasma and acrosome membranes. Progressive motility was determined by microscopic examination at $200{\times}$ magnification. Membrane integrity was assessed by use of a double fluorescent dye, and acrosome integrity by staining sperm with Pisum sativum agglutinin. The results of the first experiment showed that adding SP did not improve motility of spermatozoa compared to those incubated without SP regardless of temperature. The results of the second experiment showed that spermatozoa suspended in EYT+0.6M glycerol containing SP exhibited the higher progressive motility before being frozen(P<0.05). However, frozen-thawed spermatozoa that had suspended in EYT+0.6M glycerol containing SP showed the similar or lower viability(P<0.05). In summary, although seminal plasma did not affect spermatozoa that were chilled in EYT without cryoprotectant(CPA), addition of seminal plasma to EYT containing CPA did significantly improved progressive motility of canine spermatozoa that were chilled.

Examination and Improvement of Accuracy of Three-Dimensional Elastic Crack Solutions Obtained Using Finite Element Alternating Method (유한요소 교호법으로 구한 삼차원 균열 탄성해의 정확성 향상 및 검토)

  • Park, Jai-Hak;Nikishkov, G.P.
    • Transactions of the Korean Society of Mechanical Engineers A
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    • v.34 no.5
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    • pp.629-635
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    • 2010
  • An SGBEM (symmetric Galerkin boundary element method)-FEM alternating method has been proposed by Nikishkov, Park and Atluri. This method can be used to obtain mixed-mode stress intensity factors for planar and nonplanar three-dimensional cracks having an arbitrary shape. For field applications, however, it is necessary to verify the accuracy and consistency of this method. Therefore, in this study, we investigate the effects of several factors on the accuracy of the stress intensity factors obtained using the abovementioned alternating method. The obtained stress intensity factors are compared with the known values provided in handbooks, especially in the case of internal and external circumferential semi-elliptical surface cracks. The results show that the SGBEM-FEM alternating method yields accurate stress intensity factors for three-dimensional cracks, including internal and external circumferential surface cracks and that the method can be used as a robust crack analysis tool for solving field problems.

Examination for Structural Safety of Floating Slab Design and Shear Connector (플로팅 슬래브 설계와 전단연결재의 구조안전성 검토)

  • Park, Sung-Jae;Ma, Chang-Nam;Lee, Jong-Ho;Lee, Du-Hwa
    • Proceedings of the KSR Conference
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    • 2011.10a
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    • pp.374-374
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    • 2011
  • Recently the construction of railway sections passing the central area of cities and stations under railway lines are increasing, and then it is urgently required to take the countermeasures against the railway vibration and the second-phase noise radiated from it. The most efficient countermeasure, out of technologies developed up to now, is the floating slab track which is the track system isolated from the sub-structure by springs. In other countries, the source technologies for anti-vibration design and vibration isolator - one of key components - have been developed and many installation experiences have been accumulated. However, in Korea, since the system design technology and technologies for key components are not yet developed, the foreign system are being introduced without any adjustment, and the key component, vibration isolator, depends on imports. In this study, based on the results of previous studies of the dust-control device installation using the slab and go through time after lifting impressive when stepped on power generated by the cross-section of the slab and shear connection re-examined the structural stability.

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Investigation of Development of Bumper Back-Beam Using a Thermoplastic Polyolefin (열가소성 폴리올레핀으로 구성된 범퍼 후방 보 개발에 관한 연구)

  • Ahn, Dong-Gyu;Kim, Se-Hun;Park, Gun-Sung
    • Journal of the Korean Society for Precision Engineering
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    • v.29 no.8
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    • pp.896-905
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    • 2012
  • Recently, the application of the plastic material to automotive components and structures has steadily increased to satisfy demands on the saving of overall weight and the improvement of energy efficiency. The objective of this paper is to investigate the development of a bumper back-beam using a thermoplastic olefin (TPO). The bumper back-beam was designed to be manufactured from the injection molding process. In order to obtain a proper design of the bumper back-beam, three-dimensional finite element analyses were performed for various design alternatives. Stress-strain curves for different strain rates were measured by high speed tensile tests of the TPO to consider strain rate effects in the FEA. The influence of the sectional shape and the rib formation on the contact force-intrusion curves, the deflection and the energy absorption rate of the bumper back-beam was examined. From the results of the examination, a proper design of the bumper back-beam was acquired. The bumper back-beam consisting of TPO was fabricated from the injection moulding process and the vibration welding. Pendulum crash tests were carried out using the fabricated bumper back-beam. The results of the tests showed that the designed bumper back-beam can satisfy requirements of the federal motor vehicle safety standard (FMVSS). Through the comparison of the previously designed bumper back-beam with the newly designed bumper back beam, it was noted that the weight of the designed bumper back-beam is lighter than that of the previously designed bumper back beam by nearly 16 %. In addition, it was considered that the newly designed bumper back beam can improve recycling of the bumper back-beam.

Reliability Analysis in Designing of Reinforced Soil Structures using Uni-Modal Bounds (단일모드 구간해법을 이용한 보강토옹벽 설계의 신뢰성해석)

  • Kim, Hyun-Ki;Lee, Sung-Hyouk;Choi, Chan-Yong
    • Journal of the Korean Geosynthetics Society
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    • v.9 no.4
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    • pp.17-25
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    • 2010
  • Evaluation of stability in traditional designing of reinforced soil structures is executed by examination of internal and external stability. Analysis of internal stability is for pull-out and ductile strength. Analysis of external stability is for settlement, overturning and sliding. To minimize inherent uncertainties of soil properties and analytical model, reliability analysis was developed recently. In this study, reliability analysis method considering simultaneous failure probability for various failure mode of internal and external stability is proposed. By applying uni-modal bounds, Stability of system reliability of reinforced soil structures is evaluated by integrating multi failure mode for various analytical model. Because of complex consideration for various failure shapes and modes, it is possible to secure advanced safety by using simultaneous failure probability. And evaluation of reinforced soil structure is executed by representative index, simultaneous failure probability, than previous method.

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