• 제목/요약/키워드: intramuscular toxicity

검색결과 47건 처리시간 0.019초

FOUR-WEEK REPEATED INTRAMUSCULAR TOXICITY STUDIES OF A NEW TSUTSUGAMUSm VACCINE, MBRI-98305R IN BEAGLE DOGS

  • Ji, Hyeong-Jin;Roh,Yong-Woo;Sin, Ji-Soon;Jung, Eun-Yong;Zhang, Hu-Song;Huang, Zai-Zhi;Zheng, Mei-Shu;Choi, Ehn-Kyung;Kim, Dae-Joon;Kang, Jong-Koo
    • 한국독성학회:학술대회논문집
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    • 한국독성학회 2001년도 International Symposium on Dietary and Medicinal Antimutgens and Anticarcinogens
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    • pp.171-171
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    • 2001
  • This study was designed to evaluate a repeated dose toxicity of a new tsutsugamushi vaccine, MBRI-98305R in 4-month-old beagle dogs. Animals were intramuscularly injected with dosages of 283, 56.6, 14.15 and 0 $\mu\textrm{g}$/kg everyday for 4 weeks, respectively. There were no dose-related statistical significant changes in clinical signs, body weight changes, food or water consumption, opthalmoscopy, hematological findings and biochemical examination of all animals treated with MBRI-98305R.(omitted)

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Acute Oral, Intramuscular and Intravenous Toxicity Studies of Recombinant Interferon-$\alpha$2a in Sprague-Dawley Rats

  • Lee, Yong-Soon;Park, Jin-Sung;Che, Jeong-Hwan;Li, Guang-Xun;Kim, Tea-Won;Kim, Hyung-Sub;Park, Jie-Eun;Yun, Jun-Won;Kang, Kyung-Sun
    • Toxicological Research
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    • 제16권1호
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    • pp.73-76
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    • 2000
  • Acute oral, intramuscluar, and intravenous toxicity studies of recombinant human interferon $\alpha$2$\alpha$(rhIFN $\alpha$2$\alpha$) were performed in Sprague-Dawley (SD) rats. SD rats were administered with doses of 31.25, 62.5, 125, 250 and 500 MIU/kg, respectively, and clinical signs, mortality and body weight changes were observed for 2 weeks. In all animals administered with rhIFN $\alpha$2$\alpha$, there was neither dead animals nor significant changes of body weights. In addition, no differences were found between control and treated groups in clinical signs and autopsy findings. Therefore, $LD_{50}$ of rhIFN $\alpha$2$\alpha$ was considered to be higher than 500 MIU/kg in SD rats.

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A Study on Single Dose Toxicity of Mecasin Pharmacopuncture Injection in Muscle

  • Cha, Eunhye;Jeong, Hohyun;Lee, Jongchul;Lee, Seongjin;Park, Manyong;Kim, Sungchul
    • 대한한의학회지
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    • 제36권2호
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    • pp.36-42
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    • 2015
  • Objectives: This study was carried out to analyze the single dose toxicity of Mecasin(Gami-Jakyak Gamcho buja Decoction) pharmacopuncture in muscle of Sprague-Dawley rats. Methods: All experiments were performed at the Medvill, an institution acknowledged to conduct non-clinical studies, under the Good Laboratory Practice (GLP) regulations. Sprague-Dawley rats were chosen in this pilot study. The reason Sprague-Dawley rats were chosen is that they have been widely used in safety test in the field of medicine, so the results can be easily compared with many other databases. Doses of Mecasin pharmacopuncture, 0, 500, 1,000, and 2,000mg/kg, were registered to the experimental groups, and a dose of normal saline solution, 10 ml/kg, was registered to the control group. Mecasin pharmacopuncture and normal saline were injected into the thigh of the rats by disposable syringes at intervals of six hours twice a day. This study was performed under the approval of the Institutional Animal Ethic Committee. Results: There is no death or abnormality 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 inspect 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 outcomes suggest that treatment with Mecasin pharmacopuncture is relatively safe. Further evaluations and studies on this subject are needed to prove more concrete evidence.

Single-dose Toxicity of ShinYangHur Herbal Acupuncture

  • Cha, Eunhye;Lee, Jongcheol;Lee, Seongjin;Park, Manyong;Kim, Sungchul
    • 대한약침학회지
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    • 제18권2호
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    • pp.67-75
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    • 2015
  • Objectives: This study was carried out to analyze the single-dose toxicity of ShinYangHur (SYH) herbal acupuncture injected into the muscles of Sprague-Dawley (SD) rats. Methods: The SYH herbal acupuncture was made in a clean room at the Korean Pharmacopuncture Institute (KPI, Korea-Good Manufacturing Practice, K-GMP). After the mixing process with sterile distilled water, the pH was controlled to between 7.0 and 7.5. Then, NaCl was added to make a 0.9% isotonic solution by using sterilized equipment. All experiments were conducted at Biotoxtech, an institution authorized to perform non clinical studies under the regulations of Good Laboratory Practice (GLP). SD rats were chosen for the pilot study. Doses of SYH herbal acupuncture, 0.25, 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 Ethics 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 was used 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 outcomes suggest that treatment with SYH herbal acupuncture is relatively safe. Further studies on this subject are needed to yield more concrete evidence.

Genotoxicity Evaluation of Capsaicin-Containing (CP) Pharmacopuncture, in an In Vivo Micronucleus Test

  • Hwang, Ji Hye;Ku, Jaseung;Jung, Chul
    • 대한약침학회지
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    • 제23권4호
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    • pp.237-246
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    • 2020
  • Objectives: Capsaicin-containing (CP) pharmacopuncture was developed to treat neuropathic pain. This study was conducted to assess the toxicity of CP extract for pharmacopuncture, using a micronucleus test. Methods: First, a dose range finding study was conducted. Then an in vivo micronucleus test was performed to determine the induction of micronuclei in mouse bone marrow cells after intramuscular administration of CP twice with a 24-hour interval to 8-week-old ICR mice. A high dose of 0.2 mL/animal was selected, and this was sequentially diluted by applying a geometric ratio of 2 to produce two lower dose levels (0.1 and 0.05 mL/animal). In addition, negative and positive control groups were set up, and an HPLC analysis was conducted to confirm the capsaicin content of CP. Results: The incidence of micro-nucleated polychromatic erythrocytes in polychromatic erythrocytes in the CP-treated group was similar to that in the negative-control group, while that in the positive-control group was significantly greater. In addition, the ratio of polychromatic erythrocytes to total erythrocytes in the CP treatment group and the positive control group was not significantly different from the negative control group. In the HPLC analysis, capsaicin in the CP was identified through a comparison with the retention time of the capsaicin standard of 27 min. Conclusion: CP did not show any indication of any potential to induce micronuclei formation in bone marrow cells of ICR mice under the conditions of this study. Further toxicity studies are necessary to ensure the safety of the use of CP in clinical practice.

Effects of butaphosphan and cyanocobalamin mixture on immunity and stress in olive flounder, Paralichthys olivaceus

  • Kim, Seung Min;Kim, You Jeong;Lee, Da Won;Jun, Lyu Jin;Jeong, Joon Bum;Park, Hyun Kyung;Jeong, You Young;Lee, Sung Ho;Kwon, Mun-Gyeong;Lee, Soon Jeong
    • Fisheries and Aquatic Sciences
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    • 제23권9호
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    • pp.26.1-26.9
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    • 2020
  • Background: The study evaluated the effects of a butaphosphan and cyanocobalamin mixture on the immune system and stress in olive flounders, Paralichthys olivaceus. Methods: The mixture was intramuscularly injected into olive flounders at the current recommended dose. Furthermore, to determine the toxicity of overdose, a histological examination was performed after injection of 1-, 2-, and 4-fold higher than the recommended dose. Results: Immunity parameters were altered during the first 2 weeks after a single intramuscular injection of the mixture in olive flounders (average weight 20.5 ± 1.1 g). The levels of all tested items, except glutathione and antiprotease, were higher in the treated group than in the control group in the first week; the levels of all tested items were even higher in the second week in the treated group than in the control group. The level of nitro-blue tetrazolium, myeloperoxidase, and superoxide dismutase between the two groups differed significantly. Changes in the stress response to different seawater temperatures (increase or decrease in seawater temperature by 3-5 ℃ using 50 L heated or cooled seawater tanks) were studied by determining the changes in cortisol and glucose levels on days 1 and 7. Both cortisol and glucose levels were significantly lower in the treated group than in the control group. Histological analysis did not reveal any abnormalities after intramuscular injection of the mixture at doses that were 1-, 2-, and 4-fold higher than the recommended dose. Conclusions: Intramuscular injection of a butaphosphan and cyanocobalamin mixture is safe and effective in reducing stress and improving immunity in olive flounders.

Repeated-Dose Toxicity Testing of Scolopendrid Pharmacopuncture in Sprague-Dawley Rats

  • Jang, Jongwon;Seo, Wookcheol;Chu, Hongmin;Park, Kyungtae;Kim, SunKyung;Park, Ju-Hun;Shin, Joon young;Choi, Dong ho;Kang, Hyung Won;Kim, Sungchul
    • Journal of Acupuncture Research
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    • 제37권2호
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    • pp.110-117
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    • 2020
  • Background: The aim of this pilot study was to assess the safety and dosing of scolopendrid pharmacopuncture (SPP). Methods: A total of 40 healthy Sprague-Dawley rats (males and 20 females 20) were selected following a 7-day inspection and acclimation period. SPP was administered via intramuscular injection, over a 2-week period using 3 doses including a high-dose [0.84 mg of scolopendrid per kg of body weight (BW)], a med-dose (0.42 mg/kg BW), and a low-dose (0.21 mg/kg BW). The control group was injected with sterile water into the muscles. Unusual changes caused by administration of the test substance were observed. Weight, feed intake, organ weight, and hematological examinations were compared among the groups. Using the SPSS statistical program, Levene's test was performed to evaluate the homogeneity of variances, and a one-way ANOVA test was subsequently performed to assess the significance between each test group. Results: During the experiment no animals died. Weight change, food consumption, organ weight, hematological test, and blood biochemical tests showed no significant differences in the treatment groups compared to controls. Conclusion: No toxicological changes related to the administration of test substances were observed. Therefore, the LD50 (lethal-dose that kills 50%) of scolopendrid pharmacoupuncture in rats was greater than 0.84 mg/kg.

새로운 과립구 콜로니 자극인자(rhG-CSF) DA-3030의 국소자극성에 관한 연구 (Studies on Local Irritation of DA-3030, a new granulocyte colony stimulating factor)

  • 김옥진;안병옥;이순복;김원배;양중익
    • Biomolecules & Therapeutics
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    • 제2권3호
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    • pp.247-255
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    • 1994
  • As a series of safety studies of DA-3030, a new rhO-CSF, its local irritancy was examined in the rabbits after the following treatment; application into the conjunctival sac of the eye(single), subcutaneous injection(single), intramuscular injection(single), and intravenous injection(8-day repeated). In addition, paravenous irritation of DA-3030 was investigated in mice. The results obtained were as follows. 1. In the result of ocular irritation test, 0.03% solution of DA-3030 could be considered as a non-irritating material. 2. The local irritation of DA-3030 by an injection of 0.5mι of its solution subcutaneously or intramuscularly was negligible and not so much different from that of saline. 3. In the vascular irritancy test, macro- and microscopic observations revealed that the irritating activity of DA-3030 in blood vessels was not different from that of saline when they were injected once a day into vein retroauricularis of rabbits for 8 days.4. The paravenous administration of DA-3030 did not induce any abnormal changes at injection sites except mild swelling in 1 mouse at 3 hours after injection which was thought to be due to slow absorption. The above-mentioned results suggest that DA-3030 has no irritating activity when injected through intravenous or subcutaneous route for clinical practice as 0.03% solution.

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Study on the Single Dose Toxicity of ShinEumHur Pharmacopuncture Injected into the Muscles of Rats

  • Jeong, Hohyun;Cha, Eunhye;Lee, Jongcheol;Lee, Seongjin;Park, Manyong;Kim, Dongwoung;Song, Bongkeun;Lee, Jongdeok;Kim, Sungchul
    • 대한약침학회지
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    • 제19권4호
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    • pp.350-358
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    • 2016
  • Objectives: This study was carried out to analyze the single dose toxicity of ShinEumHur (SEH) pharmacopuncture injected into the muscles of Sprague-Dawley rats. Methods: The SEH pharmacopuncture was made in a clean room at the Korean Pharmacopuncture Institute (K-GMP). After the mixing process with sterile distilled water had been completed, the pH was controlled to between 7.0 and 7.5. All experiments were conducted at Biotoxtech, an institution authorized to perform non-clinical studies under the Good Laboratory Practice (GLP) regulations. Sprague-Dawley rats were chosen for the pilot study. Doses of SEH pharmacopuncture, 0.25, 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. We examined the survival rate, weights, clinical signs, mean hematology parameters, mean clinical chemistry, necropsy and histopathological 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. 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. Conclusion: The above findings suggest that treatment with SEH pharmacopuncture is relatively safe. Further studies on this subject are needed to yield more concrete evidence.