• 제목/요약/키워드: Good Laboratory Practice

검색결과 104건 처리시간 0.025초

Sweet BV의 조제물 농도분석 및 안정성 확인을 위한 시험적 연구 (Experimental studies of validation and stability of Sweet Bee Venom using HPLC)

  • 강계성;권기록
    • 대한약침학회지
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    • 제12권4호
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    • pp.33-50
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    • 2009
  • Objectives : This study was conducted to confirm validation and stability of concentration analysis method of pure melittin (Sweet Bee Venom-Sweet BV) extracted from the bee venom by utilizing protein isolation method of gel filtration. Methods : All experiments were conducted at Biotoxtech, a non-clinical studies authorized institution, under the regulations of Good Laboratory Practice (GLP). Standard solutions of melittin (SIGMA, USA) and test substances were dispensed and were analyzed with HPLC for Sweet BV to secure the validation of analysis. Results : 1. Measurement of system suitability of Sweet BV satisfied criterion of below 3%. 2. Confirming Linearity of Sweet BV in 10-200${\mu}g/m\ell$ solution yielded correlation coefficient (r) of 0.995 and accuracy of 85-115% which satisfy criterion. 3. Measurement of Specificity of Sweet BV didn't yield any substance affecting the peak of test substances, but detected at 21.22min verified as the test substance. 4. Confirming Intra-day of Sweet BV, accuracy and precision of 0.1, 100${\mu}g/m\ell$ were 105.70, 95.81 and 0.66, 0.73, respectively, satisfying both criteria of accuracy (85-115%) and precision (within 10%). 5. To measure Stability in autosampler, all samples used in Intra-day reproducibility sat in the autosampler for five hours and were re-analyzed. Both variability and precision satisfied the criteria. 6. Homogeneity of Sweet BV (0.1, 100${\mu}g/m\ell$) at upper, middle, and lower layers all satisfied the accuracy and precision criteria. 7. Stability of Sweet BV (0.1, 100${\mu}g/m\ell$) at room temperature for four hours and refrigerated for 7 days all satisfied the criterion. 8. For the measurement of Quality control, QC samples measured on the first and eighth day all satisfied accuracy and precision criteria. Conclusion : Above experiment data satisfies validation and stability of concentration analysis method of Sweet BV.

Sweet BV가 비글견의 심혈관계에 미치는 영향 (Effects of Sweet Bee Venom on cardiovascular system in the conscious telemetered Beagle Dogs)

  • 임청산;이광호;권기록
    • 대한약침학회지
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    • 제13권3호
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    • pp.15-46
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    • 2010
  • Objectives: This study was performed to analyse the effects of Sweet Bee Venom(Sweet BV) on cardiovascular system in the conscious telemetered Beagle Dogs. Methods: All experiments were conducted at Biotoxtech Company, a non-clinical studies authorized institution, under the regulations of Good Laboratory Practice (GLP). Male Beagle dogs of 13-19 months old were chosen for the pilot study and surgical implantation was performed for conscious telemetered Beagle dogs. And after confirming condition of Beagle dogs was stable, Sweet BV was administered 4 times(first: 0.0 mg/kg, 2nd: 0.01 mg/kg, 3rd: 0.1 mg/kg, and forth: 0.5 mg/kg, one time/week) in thigh muscle of Beagle dogs. And blood pressure, heart rate, electrocardiography and clinical responses were measured. Equal amount of normal saline to the Sweet BV experiment groups was administered to the control group. Results: 1. In the analysis of body weight and taking amount, Beagle dogs did not show significant changes. 2. In the clinical observation, responses of pain and edema were showed depend on dosage of Sweet BV. 3. In the analysis of blood pressure, treatment with Sweet BV did not show significant changes in the dosage of 0.01 mg/kg, but in the dosage of 0.1 mg/kg and 0.5 mg/kg, treatment with Sweet BV increased blood pressure significantly. 4. In the analysis of heart rate, treatment of Sweet BV did not show significant changes in all dosage and period. 5. In the analysis of electrocardiography, treatment of Sweet BV was not showed significant changes in all dosage and period. Conclusion: Above findings suggest that Sweet BV is relatively safe treatment in the cardiovascular system. But in the using of over dosage, Sweet BV may the cause of increasing blood pressure. Further studies on the subject should be conducted to yield more concrete evidences.

Sweet BV의 rat를 이용한 단회 근육시술 독성시험 (Study of single dose test of Sweet Bee Venom in rats)

  • 김영진;임청산;권기록
    • 대한약침학회지
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    • 제12권4호
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    • pp.5-32
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    • 2009
  • Objectives: This study was performed to analyse single dose toxicity of pure melittin(Sweet Bee Venom-Sweet BV) extracted from the bee venom by utilizing protein isolation method of gel filtration. Methods: All experiments were conducted at Biotoxtech, a non-clinical studies authorized institution, under the regulations of Good Laboratory Practice (GLP). Six weeks old female Sprague-Dawley rats were chosen for the pilot study and determined 30㎎/㎏ which is 4285 times higher than the clinical application dosage as the high dosage, followed by 15 and 7.5㎎/㎏ as mid and lose dosage, respectively. Equal amount of excipient to the Sweet BV experiment groups was administered as the control group. Results: 1. No mortality was witnessed in all of the experiment groups. 2. Hyperemia and movement disorder were observed around the area of administration in all groups, and higher occurrence in the higher dosage groups. Hyperemia and movement disorder diminished with elapsed time. 3. For the weight measurement, male groups showed larger reduction in weight in accordance with higher dosage. Female groups didn't s how significant changes. 4. To verify abnormalities of organs and tissues, cerebellum, cerebrum, liver, lung, kidney, and spinal nerves were removed and conducted histological observation with H-E staining. No abnormalities were detected in any of organs and tissues. 5. One female rat in the 30㎎/㎏ group had amputated toe near the administered area and histopathological finding was hemorrhage with inflammation. This is presumed as a secondary infection after the administration of Sweet BV. Conclusion: Above findings suggest Sweet BV is relatively s safe treatment medium. Further studies on the subject should be conducted to yield more concrete evidences.

A simplified method for estimating the fundamental period of masonry infilled reinforced concrete frames

  • Jiang, Rui;Jiang, Liqiang;Hu, Yi;Ye, Jihong;Zhou, Lingyu
    • Structural Engineering and Mechanics
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    • 제74권6호
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    • pp.821-832
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    • 2020
  • The fundamental period is an important parameter for seismic design and seismic risk assessment of building structures. In this paper, a simplified theoretical method to predict the fundamental period of masonry infilled reinforced concrete (RC) frame is developed based on the basic theory of engineering mechanics. The different configurations of the RC frame as well as masonry walls were taken into account in the developed method. The fundamental period of the infilled structure is calculated according to the integration of the lateral stiffness of the RC frame and masonry walls along the height. A correction coefficient is considered to control the error for the period estimation, and it is determined according to the multiple linear regression analysis. The corrected formula is verified by shaking table tests on two masonry infilled RC frame models, and the errors between the estimated and test period are 2.3% and 23.2%. Finally, a probability-based method is proposed for the corrected formula, and it allows the structural engineers to select an appropriate fundamental period with a certain safety redundancy. The proposed method can be quickly and flexibly used for prediction, and it can be hand-calculated and easily understood. Thus it would be a good choice in determining the fundamental period of RC frames infilled with masonry wall structures in engineering practice instead of the existing methods.

Study of Single-dose Toxicity of Aconitum Kusnezoffii Reichb. Pharmacopuncture in Rats

  • Kim, Jae-Kyoun;Kim, Sung-Ha;Lee, Sang-Mi;Jeong, Ho-Hyun;Park, Man-Yong;Kim, Dong-Woung;Song, Bong-Keun;Lee, Jong-Deok;Kim, Sung-Chul
    • 대한약침학회지
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    • 제15권3호
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    • pp.48-52
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    • 2012
  • Objective: This study was performed to analyze the single-dose toxicity of Aconitum kusnezoffii Reichb. pharmacopuncture (AKRP). Methods: All experiments were conducted at the Korea Testing & Research Institute (KTRI), an institute authorized to perform non-clinical studies, under the regulations of Good Laboratory Practice (GLP). Twenty (20) Sprague-Dawley rats were chosen for the pilot study. The animals were divided into four groups of five animals per group: group 1 (G1) being the control group with each animal receiving an injection of 0.3 ml of saline and groups 2, 3, and 4 (G2, G3, and G4) being the experimental groups with each animal receiving an injection of 0.1, 0.2 or 0.3 ml of AKRP, respectively. This study was conducted with the approval of the Institutional Animal Ethics Committee. Results: No deaths occurred in any of the 4 groups, and the $LD_{50}$ of AKRP administered via IV was higher than 1.77 ml/kg. Some changes in the weights of the male rates were observed between the control group and the experimental groups, but no significant differences were noted in the weights of the female rats. To check for abnormalities in organs and tissues, we stained representative sections of each specified organ with Hematoxylin & Eosin for light microscopic examination. The results showed no significant differences in any of the organs or tissues. Conclusions: The above findings suggest that Aconitum kusnezoffii Reichb. pharmacopuncture is a relatively safe treatment. Further studies on the subject should be conducted to yield more concrete evidence.

Sluice Gate를 이용한 고립파 발생조건에 따른 형상 및 압력 특성에 관한 실험적 연구 (Experimental Study of Shape and Pressure Characteristics of Solitary Wave generated by Sluice Gate for Various Conditions)

  • 조재남;김동현;이승오
    • 한국안전학회지
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    • 제31권2호
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    • pp.70-75
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    • 2016
  • Recently, coastal erosion has been widely in progress and the erosion level becomes also serious in the world wide, espeically in East Sea in Korea. Since it would threaten the life, economics and security risk, it is necessary to much comprehend the reason why coastal erosion has occurred according to the geographical characteristics. Meanwhile, analysis about hydrodynamics of the solitary wave such as tunami in swash zone is needed for the best management practice of coastal erosion. Solitary wave is nonlinear wave and can be reproduced in the laboratoy scale by openning suddenly a sluice gate with water head difference, of which methodology was found in the literature, since it could be simply determined by a significant wave height. Thus, in this sutdy the generation of solitary wave was experimentalized using the sluice gate. Experimental conditions were classified by angles of a beach slope, a water level in a beach slope and a difference of water level between in a headtank and a channel bed. Two kinds of dimensionless analyses based from experimental results in this study were presented; the first analysis indicates nondimensionalization between the wave height and the water level in a beach slope in order to investigate characteristics of solitary wave approaching the beach. The second shows the other nondimensionalization between dynamic pressure and static pressure on a beach slope to investigate the relationship between wave breaking and wave pressure. Under the same conditions as laboratory experiments, the numerical results computed with a SWAN model embedded in FLOW 3D were compared in terms of wave height, and pressure on the beach slope, which shows good agreement with each other. Overall results from this study could provide fundamental hydraulic data for the reliabile verification of numerical simulation results about coastal erosion in swash zone caused by solitary waves.

Molecular Imaging in the Age of Genomic Medicine

  • Byun, Jong-Hoe
    • Genomics & Informatics
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    • 제5권2호
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    • pp.46-55
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    • 2007
  • The convergence of molecular and genetic disciplines with non-invasive imaging technologies has provided an opportunity for earlier detection of disease processes which begin with molecular and cellular abnormalities. This emerging field, known as molecular imaging, is a relatively new discipline that has been rapidly developed over the past decade. It endeavors to construct a visual representation, characterization, and quantification of biological processes at the molecular and cellular level within living organisms. One of the goals of molecular imaging is to translate our expanding knowledge of molecular biology and genomic sciences into good patient care. The practice of molecular imaging is still largely experimental, and only limited clinical success has been achieved. However, it is anticipated that molecular imaging will move increasingly out of the research laboratory and into the clinic over the next decade. Non-invasive in vivo molecular imaging makes use of nuclear, magnetic resonance, and in vivo optical imaging systems. Recently, an interest in Positron Emission Tomography (PET) has been revived, and along with optical imaging systems PET is assuming new, important roles in molecular genetic imaging studies. Current PET molecular imaging strategies mostly rely on the detection of probe accumulation directly related to the physiology or the level of reporter gene expression. PET imaging of both endogenous and exogenous gene expression can be achieved in animals using reporter constructs and radio-labeled probes. As increasing numbers of genetic markers become available for imaging targets, it is anticipated that a better understanding of genomics will contribute to the advancement of the molecular genetic imaging field. In this report, the principles of non-invasive molecular genetic imaging, its applications and future directions are discussed.

Single Dose Toxicity of Chukyu (spine-healing) Pharmacopuncture Injection in the Muscle of Rats

  • Jeong, Hohyun;Cho, Seung-Hun;Lee, Eun-Yong;Lee, Seung-Deok;Ahn, Seong-Hun;Kim, Sungchul
    • 대한약침학회지
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    • 제17권1호
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    • pp.35-43
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    • 2014
  • Objectives: This study was performed to analyze the single dose toxicity of Chukyu (spine-healing) pharmacopuncture. Methods: All experiments were conducted at the Biotoxtech, an institution authorized to perform non-clinical studies under the regulations of Good Laboratory Practice (GLP) regulations. Sprague-Dawley rats were chosen for the pilot study. Doses of Chukyu (spine-healing) pharmacopuncture, 0.1, 0.5 and 1.0 mL, were administered to the experimental groups, and a dose of normal saline solution, 1.0 mL, was administered to the control group. This study was conducted under the approval of the Institutional Animal Ethic Committee. Results: No deaths or abnormalities occurred in any of the four groups. No significant changes in weight, hematological parameters or clinical chemistry between the control group and the experimental groups were observed. To check for abnormalities in organs and tissues, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs or tissues except in one case, where interstitial infiltrating macrophages were found in one female rat in the 0.5-mL/animal experimental group. Conclusion: The above findings suggest that treatment with Chukyu (spine-healing) pharmacopuncture is relatively safe. Further studies on this subject are needed to yield more concrete evidence.

산양산삼복합약침의 표준화 및 급성독성시험 (Component Analysis and Toxicity Study of Combined Cultivated Wild Ginseng Pharmacopuncture)

  • 백상현;이인희;김민정;김은지;하인혁;이진호;이재웅
    • 대한한방내과학회지
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    • 제36권2호
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    • pp.189-199
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    • 2015
  • Objectives: The marker substances of cultivated wild ginseng pharmacopuncture that may not be detected during the process of steaming remain controversial. We developed a combined cultivated wild ginseng pharmacopuncture that contains all the marker substances. The aim of this experiment was to investigate the marker substances and test the toxicity of the combined cultivated wild ginseng pharmacopuncture. Methods: The marker substances were detected using HPLC. Intravenous injection toxicity studies were conducted at Medvill, an authorized institution for non-clinical studies, under the regulations of Good Laboratory Practice. We observed survival rates, abnormal behaviors, weight changes, gross findings in autopsy, blood biochemical properties, and histological abnormalities of organs such as the liver and kidney. Results: HPLC data showed that ginsenosides Rg1, Rb1, and Rg3 were detected at concentrations of 19.29, 47.64, and 3.02 μ g /ml, respectively. Administration of combined cultivated wild ginseng pharmacopuncture resulted in no dead animals or significant toxicological changes. Conclusions: The combined cultivated wild ginseng pharmacopuncture contains all the marker substances and is a relatively safe treatment medium. Further studies should be conducted to confirm the present findings.

A Study on the Single-dose Oral Toxicity of Super Key in Sprague-Dawley Rats

  • Kim, Jinhee;Lee, Jongcheol;Kim, Sungchul
    • 대한약침학회지
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    • 제18권3호
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    • pp.63-67
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    • 2015
  • Objectives: This study was performed to analyze the single-dose oral toxicity of the super key (processed sulfur). Methods: All experiments were conducted at Medvill, an institution authorized to perform non-clinical studies, under the Good Laboratory Practice (GLP) regulations. In order to investigate the oral toxicity of super key. We administered it orally to Sprague-Dawley (SD) rats. The SD rats were divided into four groups of five male and five female animals per group: group 1 being the control group and groups 2, 3, and 4 being the experimental groups. Doses of super key 500 mg/kg, 1,000 mg/kg and 2,000 mg/kg were administered to the experimental groups, and a dose of normal saline solution, 10 mL/kg, was administered to the control group. We examined the survival rates, weights, clinical signs, gross findings and necropsy findings. This study was conducted under the approval of the Institutional Animal Ethics Committee. (Approval number: A01-14018). Results: No deaths or abnormalities occurred in any of the four groups. Although slight decreases in the weights of some female rats were noted, no significant changes in weights or differences in the gross findings between the control group and the experimental groups were observed. To check for abnormalities in organs, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs. Conclusion: The results of this research showed that administration of 500 - 2,000 mg/kg of super key did not cause any changes in the weights or in the results of necropsy examinations. Neither did it result in any mortalities. The above findings suggest that treatment with super key is relatively safe. Further studies on this subject are needed to yield more concrete evidence.