• Title/Summary/Keyword: Hematological value

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Intravenous Single Dose and Four-week Repented Dose Toxicity Study of YHB216, a Recombinant Human Erythropoietin, in Beagle Dogs (YHB216의 비글개에서 정맥내 단회 및 4주 반복투여독성시험)

  • 노용우;장호송;지형진;정은용;신지순;강민정;안경규;최연식;이종욱
    • Biomolecules & Therapeutics
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    • v.10 no.1
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    • pp.59-69
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    • 2002
  • Recently, recombinant human erythropoietin (rHu-EPO) has been used to treat various types of anemia. YHB216 is a new rHu-EPO developed by Yuhan Research Institute. In this study, we investigated the single dose and 4-week repeated dose toxicity of YHB216 in Beagle dogs. In the single dose toxicity study, YHB216 was administered intravenously at single dose levels of 0 and 25,000 IU/kg to dogs (2 dogs/sex/group). There were no treament-related changes in survivals, clinical signs, body weight gain, hematological values, blood chemical values, and necropsy finding during experimental period. In the repeated dose toxicity study, YHB216 was administered intravenously to dogs for 4 weeks at the dose levels of 0, 100, 500, and 2,500IU/kg (3 dogs/sex/group). There were no toxicologically significant changes in clinical signs, body weights, food and water consumptions, ophthalmoscopy, urinalysis and blood chemistry. There were increased values of red blood cell, hemoglobin, and hematocrit at all treated groups. Spleen revealed increased weight and extramedullary hematopoiesis at 500 IU/kg or more. These changes are all considered to be Pharmacology-related effects and were recovered after 4-week recovery period. From these results, it is concluded that LD50 value was above 25,000 IU/kg in the single dose toxicity study of YHB216 in dogs and the no observed adverse effect level (NOAEL) was 100 IU/kg day in the repeated dose toxicity study of YHB216 in dogs.

Acute Toxicity Study of the Hwangryunhaedok-tang Extract in ICR Mice (황련해독탕(黃連解毒湯) 열수 추출물의 급성독성 연구)

  • Lee, Ji-Hye;Eum, Hyun-Ae;Chung, Tae-Ho;Lee, Yoon-Hee;Um, Young-Ran;Yim, Nam-Hui;Kim, Dong-Seon;Ma, Jin-Yeul
    • Herbal Formula Science
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    • v.18 no.2
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    • pp.159-166
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    • 2010
  • Objective : The objective of this study was to evaluate the single dose oral toxicity of Hwangryundaedok-tang extract in ICR mice. Methods : 0(control group), 1250, 2500 and 5000 mg/kg of Hwangryundaedok-tang extracts were orally administered to 20 male and 20 female ICR mice. After single oral administration of Hwangryundaedok-tang extract to ICR mice, we observed number of the death, clinical signs, changes of body weights for 14 days. After 14 day of Hwangryundaedok-tang extract administration, all mice were sacrificed and major organs were observed. Results : Compared with the control group, we could not find any toxic signs in the mortalities, clinical signs, body weight changes, necropsy findings and hematological values in all treated groups(1250, 2500 and 5000 mg/kg). Conclusions : $LD_{50}$ value of Hwangryundaedok-tang extracts may be over 5000 mg/kg and it may have no side toxic effect to ICR mice.

The acute and sub-acute toxicity of C60/PVP complex in vivo

  • Dumpis, Marina A.;Iljin, Viktor V.;Litasova, Elena V.;Nikolaev, Dmitry N.;Bulion, Valentina V.;Krylova, Irina B.;Okunevich, Irina V.;Rodionova, Olga M.;Safonova, Albina F.;Selina, Elena N.;Piotrovsky, Levon B.
    • Advances in nano research
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    • v.4 no.3
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    • pp.167-179
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    • 2016
  • The detailed study of acute and sub-acute toxicity of the complex polyvinylpyrrolidon (PVP 20 kDa)-wrapped fullerene $C_{60}$ after intraperitoneal (ip) administration was carried out on adult male Wistar rats. The $LD_{50}$ value of $C_{60}/PVP$ complex was found to be 7, 8 g/kg. In sub-acute study which lasted for 30 days the rats were exposed to daily administration of the complex in the doses of 350 or 700 mg/kg. All animals survived during the study and had no significant changes in clinical signs, organ weight, hematological and biochemical parameters of blood. The electrophysiological properties of myocardium and the excretory function of kidneys remained normal. Histological analysis of liver, kidney and spleen at the end of the study also did not demonstrate toxic alterations. It was thus established that intraperitoneal administration of complex $C_{60}/PVP$ has no toxic effect. These results suggest that $C_{60}/PVP$ has no acute and sub-acute toxicity and is a perspective substance for potential application in biology and medicine.

Clinico-pathological studies on the experimental lead poisoning in goats I. Clinical observations(Clinical, hematological and urinary findings) (산양의 실험적 납중독에 관한 임상병리학적 관찰 I. 임상학적 관찰(증상, 혈액, 뇨))

  • Kwon, Oh-deog;Lee, Hyun-beom;Lee, Joo-mook;Chae, Joon-seok
    • Korean Journal of Veterinary Research
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    • v.32 no.1
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    • pp.127-134
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    • 1992
  • Present experiments were undertaken in order to clarify the clinico-pathological characteristics of lead poisoning in goats. Twenty goats were divided into three experimental groups(A, B and C) and a control(D). The three experimental groups received diets contaminated artificially with 10(A group), 200(B group) and 1,000(C group) ${\mu}g/$ of lead, for 70 days respectively. The control group received normal diets. Blood samples were collected 1 or 2 weeks interval and were examined for anemia(erythrocyte counts, hemoglobin concentrations and hematocrit values) and lead contents of erythrocyte and serum. Urine samples collected similarly with blood were examined for delta-aminolevulinic acid and lead content. Collected samples were analyzed for lead content by atomic absorption spectrophotometry. From these experiments following results were obtained : In group B and C, marked decreases in body weight and feed intake, and diarrhea were observed from the $30^{th}$ day of experimental periods. The B and C groups showed pronounced anemia(decrease in erythrocyte count, hemoglobin concentration and hematocrit value) from the $21^{st}$ or $42^{nd}$ day. In group B and C, the lead content of erythrocytes was increased significantly from the $28^{th}$ or $14^{th}$ day. The lead content of serum was increased significantly from the $42^{nd}$ or $14^{th}$ day in B and C groups. The lead content of urine was increased significantly from the first day in both B and C groups. The urinary delta-aminolevulinic acid content was increased significantly from $14^{th}$ day in both B and C groups.

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Acute Oral Toxicity of Alismatis Rhizoma in SD Rats (택사(Alismatis Rhizoma) 추출물의 급성 경구투여 독성 연구)

  • Seok, Ji-Hyun;Roh, Hang-Sik;Jeong, Ja-Young;Ha, Hun-Yong
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.26 no.4
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    • pp.15-25
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    • 2013
  • Objectives : This study was carried out to evaluate the acute oral toxicity of Alismatis Rhizoma in Sprague-Dawley(SD) rats. Methods : male and female rats were administered orally with Alismatis Rhizoma water extract of 1,000 mg/kg (low dosage group), 2,000 mg/kg(middle dosage group) and 4,000 mg/kg(high dosage group). We daily observed number of deaths, clinical signs and gross findings for 7 days. After 7 days, we measured body and organs weight. Also we analyzed hematological changes. Results : No dead SD rats and no clinical signs were found during the experiment period. Also other specific changes were not found between control and treated groups in hematology and serum biochemistry. In addition no significant changes of gross body and individual organs weight. Conclusions : These results suggest that water soluble extract of Alismatis Rhizoma has not acute oral toxicity and oral $LD_{50}$ value was over 4,000 mg/kg in SD rats.

A Repeated-dose 28-Day Oral Toxicity Test of Aconitum jaluense Extract in Sprague-Dawley Rats (초오 추출물의 Sprague-Dawley 랫드를 이용한 28일 반복 경구투여독성시험)

  • Lee, Jong Suk;Lee, Ji Sun;Park, Yeong-Chul;Choi, Sun Mi;Lee, Sanghun
    • YAKHAK HOEJI
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    • v.58 no.1
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    • pp.62-70
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    • 2014
  • A 28-day repeated-dose oral toxicity test was performed to determine the no-observed-effect level (NOEL) and establish an optimum dose of the highly toxic Aconiti Ciliare Tuber (ACT) used as a folk remedy. Repeated oral doses of 1,250, 2,500, and 5,000 mg/kg/day of the hot water extract of ACT were administered to five male and five female Sprague-Dawley rats in each group for 4 weeks. The indicators for toxicity included results of examination of common symptoms and changes in weight and feed intake, eye test, urinalysis, hematological and serum biochemical analyses, and post-mortem weight measurement of organs, and visual inspections. All animals survived at the end of the experiment; in addition, we observed no specific test substance-mediated symptoms. We observed no test substance-mediated changes in body weight and feed intake. We observed statistically significant changes in male OB and pH levels (p<0.05). Further, the biochemical test showed statistically significant changes in the IP value of male rats and $CL^-$valueoffemalerats (p<0.05). However, all changes were within historical data. The post-mortem examinations showed no test substance-mediated changes. Moreover, statistically significant changes under the test conditions were confirmed to have been caused by factors other than the test substance. Thus, the maximum NOEL of ACT extract in rats was estimated to be 5,000 mg/kg/day.

A convergence study about Influences of hematopoietic stem cell transplantation on children growth (소아암 환아의 조혈모세포이식 후 성장에 관한 융합 연구)

  • Lim, Su-Jin
    • Journal of the Korea Convergence Society
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    • v.8 no.4
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    • pp.49-57
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    • 2017
  • This is a convergence study about influences of hematopoietic stem cell transplantation on children growth. For this explanatory survey research, data were collected with medical record of 112 children with malignant and hematological diseases received HSCT from February to March, 2009. To analyze the growth after HSCT, mixed-effects model was used. The mean SDS of height and weight were negative values in HSCT. The mean value of SDS were significantly lower in autologous HSCT group by height(p=0.0008) and weight(p= 0.0012). Significant factors on changes of SDS of height growth were age at HSCT(p=0.0251), autologous HSCT(p=0.0020) and total dose of steroid in allogeneic HSCT (p=0.0403) and age at HSCT(p=0.0042), autologous HSCT(p=0.0035), and duration of TPN(p=0.0159) for weight growth. According to the results, we must learn to recognize the predicting growth impairment after HSCT in children. regarding nursing interventions should be conducted in the care of these children.

Repeated Dose Oral Toxicity Study of Alismatis Rhizoma in SD Rats (택사(Alismatis Rhizoma) 추출물의 반복 경구투여 독성 연구)

  • Roh, Hang-Sik;Seok, Ji-Hyun;Jeong, Ja-Young;Lee, Jong-Kwon;Kim, Tae-Sung;Choi, Hye-Kyung;Ha, Hun-Yong
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.27 no.1
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    • pp.79-90
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    • 2014
  • Objectives : This study was carried out to evaluate the repeated dose oral toxicity of Alismatis Rhizoma in Sprague-Dawley(SD) rats. Methods : Male and female rats were administered orally with Alismatis Rhizoma water extract of 500 mg/kg(low dosage group), 1,000 mg/kg(middle dosage group) and 2,000 mg/kg(high dosage group). We daily observed number of deaths, clinical signs and gross findings for 14 days(twice a day). After 14 days, we measured body and organs weight. Also we analyzed hematological changes. Results : No dead SD rats and no clinical signs were found during the experiment period. Also other specific changes were not found between control and treated groups in hematology and serum biochemistry. In addition no significant changes of gross body and individual organs weight. Conclusions : These results suggest that water soluble extract of Alismatis Rhizoma has not repeated dose oral toxicity and oral LD50 value was over 2,000 mg/kg in SD rats. As a result, we can determine Alismatis Rhizoma is a relatively safe substance.

A Clinical Study on the Treatment of Atopic Dermatitis by Using Kami-chungsimyeunjatang(加味淸心蓮子湯) (가미청심련자탕(加味淸心蓮子湯)의 아토피 피부염 치료에 대한 임상고찰)

  • Song, Hyun-Jee;Han, Jae-Kyung;Kim, Yun-Hee
    • The Journal of Pediatrics of Korean Medicine
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    • v.21 no.3
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    • pp.21-31
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    • 2007
  • Objectives The purpose of this study is to investigate the clinical effect of Kami-chungsimyeunjatang on atopic dermatitis and to survey the general characteristics in children with atopic dermatitis. Methods 30 patients suffering from atopic dermatitis were treated with water extract of Kami-chungsimyeunjatang and the clinical evaluation were made by SCORAD index system before and after treatment. We also investigated some characteristics of improvements by using questionnaire. Results 1. Among 30 patients diagnosed as atopic dermatitis, 18 of the people were male(60%) and 12 of the people were female(40%). 2. Among 30 patients diagnosed as atopic dermatitis, 24 of them have family history of allergic disease(80%) and 18 of them have past history of allergic disease(60%). 3. The distribution of nursing method, 13 of them (44%) had powdered milk, 10(33%) of them had both breast milk and powdered milk, 7 of them (23%) had only breast milk. 4. 20 patients(67%) who have atopic dermatitis were less than 1 year old and 6 of them (20%) were between 1 or 2 years old. The initial lesion of 22(74%) of the patients were face and neck. 5. 9 patients(30%) of them answered that the symptoms are getting worse especially during the winter while 8 patients(25%)of them said summer. 6. The mean period of treatment value was $4.6{\pm}2.20$ months. 7. After treatment, there was statistically significant decrease(p<0.05) of extent, intensity, subjective symptoms and total SCORAD index score(p=0.001). 8. After treatment, 28(93%) of the patients were improved. Conclusions Considering the above results, we speculate that Kami-chungsimyeunjatang is effective in the treatment of atopic dermatitis, and further studies are needed with more clinical cases of hematological evaluation.

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A Study on Subchronic Inhalation Toxicity of Isoprene Using Sprague-Dawely Rats (Isoprene 아급성 흡입독성 연구)

  • Chung, Yong Hyun;Lee, Sung Bae;Han, Jeong Hee;Kang, Min Gu;Kim, Jong Kyu;Rim, Kyung Taek;Yang, Jung Sun
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.21 no.2
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    • pp.73-81
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    • 2011
  • The purpose of this study was to obtain scientific information regarding classification and health hazards that may result from a 13 weeks inhalation exposure of isoprene in Sprague-Dawley (SD) rats. The testing method was conducted in accordance with OECD guidelines for the testing of chemicals No. 413. The Rats were divided into 4 groups (10 male and 10 female rats in each group) and exposed to 0, 360, 1,620, 7,300 ppm isoprene in each exposure chamber for 6 h/day, 5 days/week, for 13 weeks. As a result, there were no mortality or abnormality during the period of study and did not show any significant changes of body weight. There were no dose response changes in urinalysis, hematological and serum biochemical value examination. Relative organ weight was increased significantly the right kidney in 7,300 ppm group of male rats. In female rats, relative organ weight of the left kidney and the both lungs in 1,620 ppm group and the left lung and the both kidneys in 7,300 ppm group were increased significantly. But the histopathological findings did not reveal any exposure-related changes. According to the above results, the no observable adverse effect level (NOAEL) of isoprene was 7,300 ppm (20.3 mg/L) in both male and female rats. In conclusion, Isoprene was not classified specific target organ toxicity of the 'Standard for Classification and Labeling of Chemical Substance and Material Safety Data Sheet' (Ministry of Employment and Labor, 2009).