• Title/Summary/Keyword: Good Laboratory Practice

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Effect of nutritional supplement formula on catch-up growth in young children with nonorganic faltering growth: a prospective multicenter study

  • Shim, Jung Ok;Kim, Seung;Choe, Byung-Ho;Seo, Ji-Hyun;Yang, Hye Ran
    • Nutrition Research and Practice
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    • v.14 no.3
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    • pp.230-241
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    • 2020
  • BACKGROUND/OBJECTIVES: Inadequate nutrition in infants and young children affects physical growth and neurocognitive development. Therefore, early nutritional intervention is important to promote catch-up growth in young children with faltering growth. The aim of this study was to evaluate the effect of nutritional supplementation with a pediatric concentrated and balanced nutritional supplement formula on promoting growth and improving nutritional status in children with nonorganic faltering growth. SUBJECTS/METHODS: Children aged 12-36 months whose body weight-for-age was < 5th percentile on the Korean Growth Charts were enrolled. Children born premature or having organic diseases were excluded. Children were instructed to consume 400 mL of formula per day in addition to their regular diet for 6 months. Pediatricians and dietitians educated the parents and examined the subjects every 2 months. Anthropometric parameters were measured at baseline and at 2, 4, and 6 months, and laboratory tests were done at baseline and 6 months. The good consumption group included children who consumed ≥ 60% of the recommended dose of formula. RESULTS: Total 82 children completed the 6-month intervention. At baseline, there were no significant differences in all variables between the good consumption and poor consumption groups. Weight and weight z-scores were significantly improved in the good consumption group compared to the poor consumption group at the end of the intervention (P = 0.009, respectively). The good consumption group showed a significant trend for gaining weight (P < 0.05) and weight z-score (P < 0.05) compared to the poor consumption group during 6 months of formula intake. The concentration of blood urea nitrogen was significantly increased in the good consumption group (P = 0.001). CONCLUSIONS: Nutritional supplementation with a concentrated and balanced pediatric nutritional formula along with dietary education might be an effective approach to promote catch-up growth in children with nonorganic faltering growth.

Screening of Staphylococcus aureus and Staphylococcal Enterotoxin a, b, c gene in Strains Isolated from Strawberry Farms in Western Gyeongnam (서부 경남지역 딸기 농장에서의 Staphylococcus aureus의 분리와 Staphylococcal enterotoxin a, b, c gene 검색)

  • Kim, Se-Ri;Shim, Won-Bo;Kim, Ji-Hun;Hwang, Seung-Jae;Park, Seon-Ja;Ha, Sang-Do;Kim, Keun-Sung;Lee, Kyu-Ho;Kim, Min-Gon;Kim, Kwang-Yup;Kim, Cheol-Ho;Chung, Duck-Hwa
    • Korean Journal of Food Science and Technology
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    • v.37 no.2
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    • pp.321-327
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    • 2005
  • Staphylococcus aureus is spread worldwide and can result in food poisoning outbreaks. Among samples collected from soil, water, protected houses, packing houses, employees, strawberries, and leaves, and analyzed for S. aureus contamination, 16% samples 'showed S. aureus contamination, particularly on employees' hands, scissors, and strawberries. Examination of enterotoxins A, B, and C genes of S. aureus by PCR revealed sea and seb in 92 and 38% of total strains, respectively, whereas sec was not detected. In conclusion, implementation of Good Agricultural Practice is necessary for preventing food-borne diseases of staphylococcal origin, thereby ensuring the safety of farm-to-table products.

Alternative Immunossays

  • Barnard, G.J.R.;Kim, J.B.;Collins, W.P.
    • Korean Journal of Animal Reproduction
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    • v.9 no.2
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    • pp.133-139
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    • 1985
  • An immunoassay may be defined as an analytical procedure involving the competitive reaction between a limiting concentration of specific antibody and two populations of antigen, one of which is labelled or immobillized. The advent of immunoassay has revolutionised our knowledge of reproductive physiology and the practice of veterinary and clinical medicine. Radioimmunoassay (RIA) was the first of these methods to be developed, which meausred the analyte with good sensitivity, accuracy and precision (1,2). The essential components of RIA are:-(i) a limited concentration of antibodies, (ii) a reference preparation, and (iii) an antigen labelled with a radioisotope (usually tritium or iodine-125). Most procedures invelove isolating the antibody-bound fraction and measuring the amount of labelled antigen. Good facilities are available for scintilltion counting, data reduction nd statistical analysis. RIA is undergoing refinement through:-(i) the introduction of new techniques to separate the antibody-bound and free fractions which minimize the misclassification of labelled antigen into these compartments, and the amount of non-specfic binding. (3), (ii) the development of non-extration for the measurement of haptens (4), (iii) the determination of a, pp.rent free (i.e. non-protein bound) analytes (5), and (iv) the use of monoclonal antibodies(6). In 1968, Miles and Hales introduced in important new type of immunoassay which they termed immunora-diometric assay (IRMA) based on t도 use of isotopically labelled specific antibodies(7) in a move from limited to excess reagent systems. The concept of two-site IRMAs (with a capture antibody on a solid-phase, and a second labelled antibody to a different antigenic determinant of the analyte) has enabled the development of more sensitive and less-time consuming methods for the measurement of protein hormones ovar wide concentration of analyte (8). The increasing use of isotopic methos for diverse a, pp.ications has exposed several problems. For example, the radioactive half-life and radiolysis of the labelled reagent limits assay sensitivity and imposes a time limit on the usefulness of a kit. In addition, the potential health hazards associated with the use and disposal of radioactive cmpounds and the solvents and photofluors necessary for liquid scientillation counting are incompatable with the development of extra-laboratory tests. To date, the most practical alternative labels to radioisotopes, for the measurement of analytes in a concentration > 1 ng/ml, are erythrocytes, polystyrene particiles, gold sols, dyes and enzymes or cofactors with a visual or colorimetric end-point(9). Increased sensitivity to<1 pg/ml may be obtained with fluorescent and chemiluminescent labels, or enzymes with a fluorometric, chemiluminometric or bioluminometric end-point. The sensitivity of any immunoassay or immunometric assay depends on the affinity of the antibody-antigen reaction, the specific activity of the label, the precision with which the reagents are manipulated and the nonspecific background signal (10). The sensitivity of a limited reagent system for the measurement of haptens or proteins is mainly dependent upon the affinity of the antibodies and the smalleest amount of reagent that may be manipulated. Consequently, it is difficult in practice to improve on the sensitivity obtained with iodine-125 as the label. Conversely, with excess reagent systems for the measurement of proteins it is theoretically possible to increase assay sensitivity at least 1000 fold with alternative luminescent labels. To date, a 10-fold improvement has been achieved, and attempts are being made to reduce the influence of other variables on the specific signal from the immunoreaction.

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Epidemiological Characterization of Group A Streptococci Using emm Genotyping from Throat Cultures in Patients with Acute Pharyngitis in Children (소아과 의원을 방문한 급성인두염 환자의 인후배양과 emm 유전자형을 이용한 A군 연쇄구균의 역학조사)

  • Jung, Hyun Ju;Lee, Nam Yong;Kwon, Oh-Young;Maeng, Kook Young;Kim, Sunjoo
    • Pediatric Infection and Vaccine
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    • v.10 no.2
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    • pp.178-185
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    • 2003
  • Purpose : Group A streptococci(GAS) was isolated from the patients with acute pharyngitis. Epidemiological studies using T typing and emm genotyping was performed for GAS and compared with the results of the carriers. Methods : Throat cultures were taken from 246 children(123 boys, 123 girls) from November, 2001 to May, 2002 who visited a pediatrician's office located in Jinju, Gyeongnam province. T types were identified with slide agglutination and emm genotypes were identified with DNA sequencing after amplification of emm genes. Results : One hundred thirty(52.8%) out of 246 children yielded beta-hemolytic streptococci, of which 96.1% were group A. Children from 4 to 7 years old comprised 70.4% of the GAS positive group. T12 were the most common(35.2%) and T non-typeable strains were the next(30.4%). emm12 was most frequent(28.5%), and emm75(18.7%), emm22(13.0%), emm2(12.2%), and emm8(8.1%) were relatively common. Conclusion : Since GAS is so highly prevalent in acute pharyngitis, indeed being half of the population, good clinical practice dictates the systematic employment of throat culture for acute pharyngitis before prescribing antibiotics in a pediatric setting. The distribution of the T antigens and emm genes showed similar pattern between the acute pharyngitis and the carriers.

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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.

Intravenous Injection of Saeng Maek San - A Safe Method of Treatment in Rats

  • Choi, Min-Ji;Kim, Sung-Chul;Cho, Seung-Hun
    • Journal of Pharmacopuncture
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    • v.17 no.2
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    • pp.67-72
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    • 2014
  • Objectives: This study evaluated the single-dose toxicity of Saeng Maek San (SMS) in rats. Methods: All experiments were conducted at Biotoxtech (Chungwon, Korea), an institute authorized to perform non-clinical studies under the regulations of Good Laboratory Practice (GLP). A single-dose intravenous toxicity study was carried out on 40 6-week-old Sprague-Daley rats. The animals were randomly divided into the following four groups of ten animals each: Group 1 (G1) was the control group, with each animal receiving an intravenous injection of 1.0 mL of saline, and Groups 2, 3 and 4 (G2, G3 and G4) were the experimental groups, with the animals in the groups receiving an injection of 0.1, 0.5 and 1.0 mL of SMS, respectively. Mortality, clinical signs, body-weight changes and gross pathological findings were observed for 14 days following a single administration of SMS or saline. Organ weights, clinical chemistry and hematology were analyzed at 14 days. This study was conducted with the approval of the Institutional Animal Ethics Committee. Results: No deaths occurred in any of the four groups, indicating that the lethal dose of SMS in rats is greater than 1.0 mL/animal. Some changes in weights of male rats between the control group and the experimental groups were observed, but no significant changes in the weights of female rats were noted. To identify abnormalities in organs and tissues, we stained representative sections of each specified organ with hematoxylin and eosin for examination with a light microscope. No significant abnormalities were observed in any of the organs or tissues. Conclusion: The results suggest that intravenous injection of SMS is a safe method of treatment.

A Pilot Study on Single-dose Toxicity Testing of Scolopendrid Pharmacopuncture in Sprague-Dawley Rats

  • Son, Ilhong;Lee, Sangmi;Kim, Doho;Jeong, Hohyung;Cho, Seung-Hun;Lee, Eun-Yong;Lee, Seung-Deok;Ahn, Seong-Hun;Kim, Sungchul
    • Journal of Pharmacopuncture
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    • v.17 no.2
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    • pp.57-66
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    • 2014
  • Objectives: This study was performed to analyze single dose toxicity and the lethal dose of Scolopendrid Pharmacopuncture in rats. Methods: All experiments were conducted at the Korea Testing & Research Institute (KTR), an institution authorized to perform non-clinical studies, under the regulations of Good Laboratory Practice (GLP). Sprague-Dawley rats were chosen for the pilot study. Doses of Scolopendrid pharmacopuncture, 0.1, 0.5, and 1.0 mL, were administered to the experimental group, and 1.0 mL doses of normal saline solution were 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 groups. No significant changes in the weight, hematological parameters or clinical chemistry were noted between the control group and the experimental group. 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. Conclusion: The above findings suggest Scolopendrid Pharmacopuncture is a relatively safe to use for treatment. Further studies on the subject should be conducted to yield more concrete evidence.

A Study on the Oral Toxicity of Mecasin in Rats

  • Jeong, Hohyun;Lee, Jongchul;Cha, Eunhye;Park, Manyong;Son, Ilhong;Song, Bongkeun;Kim, Sungchul
    • Journal of Pharmacopuncture
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    • v.17 no.4
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    • pp.61-65
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    • 2014
  • Objectives: In this study, we investigated the oral toxicity of Gami-Jakyak Gamcho buja Decoction (Mecasin) to develop safe treatments. Methods: All experiments were conducted at the Medvill, an institution authorized to perform non-clinical studies, under the Good Laboratory Practice (GLP) regulations. In order to investigate the oral toxicity of Mecasin, we administered Mecasin orally to rats. Sprague-Dawley 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 Mecasin, 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 rate, weight, clinical signs, and gross findings. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: No deaths or abnormalities occurred in any of the four groups. Although slight decreases in the weights of some female rats were noted on the third day, no significant changes in weights or 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 showed that administration of 500 - 2,000 mg/kg of Mecasin did not cause any changes in weight or in the results of necropsy examinations. It also did not result in any mortalities. The above findings suggest that treatment with Mecasin is relatively safe. Further studies on this subject are needed to yield more concrete evidence.

Study on a Single-Dose Toxicity Test of D-Amino Acid Oxidase (DAAO) Extracts Injected into the Tail Vein of Rats

  • Kang, Jungue;Lee, Eun-Yong;Song, Bong-Keun;Lee, Seung-Deok;Yook, Tae-Han;Ahn, Seong-Hun;Son, Il-Hong;Kim, Sungchul
    • Journal of Pharmacopuncture
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    • v.16 no.2
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    • pp.28-32
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    • 2013
  • Objective: This study was performed to analyze the single-dose toxicity of D-amino acid oxidase (DAAO) extracts. Methods: All experiments were conducted at the Korea Testing & Research Institute (KTR), an institution authorized to perform non-clinical studies, under the regulations of Good Laboratory Practice (GLP). Sprague-Dawley rats were chosen for the pilot study. Doses of DAAO extracts, 0.1 to 0.3 cc, were administered to the experimental group, and the same doses of normal saline solution were administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: In all 4 groups, no deaths occurred, and the $LD_{50}$ of DAAO extracts administered by IV was over 0.3 ml/kg. No significant changes in the weight between the control group and the experimental group 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 organs or tissues. Conclusion: The above findings suggest that treatment with D-amino acid oxidase extracts is relatively safe. Further studies on this subject should be conducted to yield more concrete evidence.

Study of single dose toxic test of Sweet Bee Venom in Beagle Dogs (Sweet Bee Venom의 비글견을 이용한 단회근육시술 독성시험)

  • Yoon, Hye-Chul;Lee, Kwang-Ho;Kwon, Ki-Rok
    • Journal of Pharmacopuncture
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    • v.13 no.4
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    • pp.43-61
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    • 2010
  • Objectives : This study was performed to analyse single dose toxicity of Sweet Bee Venom(Sweet BV) extracted from the bee venom in Beagle dogs. Methods : All experiments were conducted under the regulations of Good Laboratory Practice (GLP) at Biotoxtech Company, a non-clinical study authorized institution. Male and female Beagle dogs of 5-6 months old were chosen for the pilot study of single dose toxicity of Sweet BV which was administered at the level of 9.0 mg/kg body weight which is 1300 times higher than the clinical application dosage as the high dosage, followed by 3.0 and 1.0 mg/kg as midium and low dosage, respectively. Equal amount of excipient(normal saline) 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 the experiment groups, and higher occurrence in the higher dosage treatment. 3. For weight measurement, Neither male nor female groups showed significant changes. 4. To verify abnormalities of organs and tissues, thigh muscle which treated with Sweet BV, brain, liver, lung, kidney, and spinal cords were removed and histologocal observation using H-E staining was conducted. In the histologocal observation of thigh muscle, cell infiltration, inflammation, degeneration, necrosis of muscle fiber, and fibrosis were found in both thigh tissue. And the changes depend on the dose of Sweet BV. But the other organs did not showed in any abnormality. 5. The maximum dose of Sweet BV in Beagle dogs were over 9 mg/kg in this study. Conclusions : The above findings of this study suggest that Sweet BV is a relatively safe treatment medium. Further studies on the toxicity of Sweet BV should be conducted to yield more concrete evidences.