• Title/Summary/Keyword: Single-dose toxicity

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Intravenous Single Dose Toxicity of Sweet Bee Venom in Sprague-Dawley Rats

  • Lee, Kwang-Ho;Yu, JunSang;Sun, Seungho;Kwon, KiRok
    • Journal of Pharmacopuncture
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    • v.18 no.3
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    • pp.49-56
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    • 2015
  • Objectives: Anaphylactic shock can be fatal to people who become hypersensitive when bee venom pharmacopuncture (BVP) is used. Thus, sweet bee venom (SBV) was developed to reduce these allergic responses. SBV is almost pure melittin, and SBV has been reported to have fewer allergic responses than BVP. BVP has been administered only into acupoints or intramuscularly, but we thought that intravenous injection might be possible if SBV were shown to be a safe medium. The aim of this study is to evaluate the intravenous injection toxicity of SBV through a single-dose test in Sprague-Dawley (SD) rats. Methods: Male and female 6-week-old SD rats were injected intravenously with SBV (high dosage: 1.0 mL/animal; medium dosage: 0.5 mL/animal; low dosage: 0.1 mL/animal). Normal saline was injected into the control group in a similar method. We conducted clinical observations, body weight measurements, and hematology, biochemistry, and histological observations. Results: No death was observed in any of the experimental groups. Hyperemia was observed in the high and the medium dosage groups on the injection day, but from next day, no general symptoms were observed in any of the experimental groups. No significant changes due to intravenous SBV injection were observed in the weights, in the hematology, biochemistry, and histological observations, and in the local tolerance tests. Conclusion: The results of this study confirm that the lethal dose of SBV is over 1.0 mL/animal in SD rats and that the intravenous injection of SBV is safe in SD rats.

Intravenous Single-dose Toxicity of Mountain Ginseng Pharmacopuncture in Sprague-Dawley Rats

  • Lee, Kwangho;Sun, Seungho;Yu, Junsang;Lim, Chungsan;Kwon, Kirok
    • Journal of Pharmacopuncture
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    • v.17 no.3
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    • pp.50-56
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    • 2014
  • Objectives: Mountain ginseng pharmacopuncture (MGP) is an extract distilled from either mountain cultivated ginseng or mountain wild ginseng. This is the first intravenous injection of pharmacopuncture in Korea. The word intravenous does not discriminate between arteries, veins, and capillaries in Oriental Medicine, but only the vein is used for MGP. The aim of this study is to evaluate the intravenous injection toxicity of MGP through a single-dose test in Sprague-Dawley (SD) rats. Methods: Male and female 6-week-old SD rats were injected intravenously with MGP (high dosage of 20 mL/kg or low dosage of 10 mL/kg). Normal saline was injected into the rats in the control group by using the same method. After the rats has treated, we conducted clinical observations, body-weight measurements and histological observations. Results: In this study, no mortalities were observed in any of the experimental groups. Also, no significant changes by the intravenous injection of MGP were observed in the body weights, or the histological observations in any of the experimental groups compared to the control group. The lethal dose for intravenous injection of MGP was found to be over 20 mL/kg in SD rats. Conclusion: Considering that the dosage of MGP generally used each time in clinical practice is about 0.3 mL/kg, we concluded with confidence that MGP is safe pharmacopuncture.

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

  • Cha, Eunhye;Jeong, Hohyun;Lee, Jongchul;Lee, Seongjin;Park, Manyong;Kim, Sungchul
    • The Journal of Korean Medicine
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    • v.36 no.2
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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
    • Journal of Pharmacopuncture
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    • v.18 no.2
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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.

Potential ameliorative effects of bilberry (Vaccinium myrtillus L.) fruit extract on cisplatin-induced reproductive damage in adult male albino rats

  • Fatma B. Mossa;Nadia Bakry;Mamdouh Rashad El-Sawi
    • Clinical and Experimental Reproductive Medicine
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    • v.51 no.3
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    • pp.192-204
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    • 2024
  • Objective: Cisplatin (CP) is a widely used chemotherapeutic agent, but its severe side effects impact testicular function. We investigated the potential protective effects of bilberry extract against CP-induced testicular toxicity. Methods: Forty adult male albino rats were divided into four groups. Control animals received a single oral dose of 0.9% saline. Bilberry-treated rats received oral bilberry extract (200 mg/kg body weight [BW] dissolved in 1 mL of saline) daily for 10 consecutive days. CP-treated animals were administered a single intraperitoneal dose (7.5 mg/kg BW). Finally, a bilberry+CP group received oral bilberry extract (200 mg/kg BW) daily for 10 consecutive days, with one intraperitoneal dose of CP (7.5 mg/kg BW) on day 2. We assessed sperm count, motility, viability, and abnormalities, along with testis weight, testis weight-to-BW ratio, antioxidant activity, levels of oxidative stress markers (malondialdehyde [MDA] and hydrogen peroxide [H2O2]), sex hormones (follicle-stimulating hormone [FSH], luteinizing hormone [LH], and testosterone), and apoptotic and anti-apoptotic markers, and DNA damage. Testicular tissue underwent histopathological examination. Results: Among CP-treated rats, significantly lower values were observed for testis weight; testis weight-to-BW ratio; levels of FSH, LH, testosterone, superoxide dismutase, catalase, glutathione S-transferase, glutathione, and B-cell lymphoma 2; and sperm count, motility, and proportion of normal sperm. CP administration was associated with higher MDA, H2O2, p53, Bax, cytochrome c, caspase 9, and caspase 3 levels, along with elevated tail moment. However, bilberry extract administration significantly improved all altered parameters. Conclusion: Bilberry treatment demonstrated protective effects and reduced CP-induced testicular toxicity via antioxidant activity and cytoprotection.

Acute and Subacute Toxicity Study of Artemisia asistica Nakai Aqua-acupuncture Solution in Mice (애엽(艾葉) 약침액(藥鍼液)의 급성(急性)·아급성(亞急性) 독성(毒性)에 관한 연구(硏究))

  • Youn, Seong-Muk;Lim, Jong-Kook
    • Journal of Acupuncture Research
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    • v.17 no.1
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    • pp.143-151
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    • 2000
  • Acute and subacute toxicity of Artemisia asistica Nakai Aqua-acupuncture Solution (ANAS) were studied in ICR mice. In acute toxicity test, mice were injected intraperitoneally with single dose of $1{\times}$, $5{\times}$, $10{\times}$ ANAS, and toxicological responeses were observed for consecutive 14 days. Mortality, body weight changes, organ weight, and serum chemistry were performed. The mortality and body weight changes of mice treated with $1{\times}$ and $5{\times}$ ANAS were not affected during the experimental periods. With the $10{\times}$ ANAS treatment, there were dead animals and changes of body weight, organ weight and serum biochemical values were observed during the experimental period. In subacute toxicity test, mice were injected intraperitoneally with doses of $1{\times}$, $10{\times}$ ANAS for 14 days. No difference was found between control and $1{\times}$ ANAS treated group in mortality, changes of body weight and organ weight, and serum biochemical values. However, Dead animals, changes of body weight and organ weight, and increased serum biochemical values were observed with $10{\times}$ ANAS treated groups. These results suggest that $1{\times}$ ANAS causes no toxicity in acute and subacute toxicity tests. However $10{\times}$ ANAS causes toxicity in both tests.

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Evaluation of Acute and Sub-acute Oral Toxicity Effect of Aquilaria malaccensis Leaves Aqueous Extract in Male ICR Mice

  • Musa, Nur Hidayat Che;Zain, Haniza Hanim Mohd;Ibrahim, Husni;Jamil, Nor Nasibah Mohd
    • Natural Product Sciences
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    • v.25 no.2
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    • pp.157-164
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    • 2019
  • The study was conducted to investigate the acute and sub-acute toxicity effect of Aquilaria malaccensis leaves aqueous extract (AEAM) towards male ICR mice in terms of body weight, relative organ weight, mortality rate and sperm parameters. In acute toxicity study, a single dose at of 2000 mg/kg was performed. In sub-acute toxicity study, the mice were received normal saline (control group), 50, 100, 150, 200, 500, or 1000 mg/kg of AEAM orally for 21 days of treatment. In sub-acute toxicity study, the number of abnormal sperm were significantly decreased in AEAM 100, 150, 200, 500, and 1000 when compared to the control group. While, the motility of sperm were found to be significantly increased in AEAM 100, 150, 200, and 1000 as compared to the control group. No mortality was recorded in the control group and treated groups in both toxicity studies except for one mouse from AEAM 1000 group. However, the mild sedative effect in terms of the tendency to sleep was clearly noticeable in both toxicity studies. Results indicated that the AEAM can be one of the useful alternative medicine to enhance fertility rate by increasing healthy sperm production.

Single Dose Oral Toxicity Study of Cicadidae Periostracum Extracts in Sprague-Dawley Rats (선퇴 추출물의 Sprague-Dawley rat를 이용한 단회 경구 투여 독성시험)

  • Byung-Suk Jeon;Huiyeong Jeong;Sueun Lee;Yun-Soo Seo;Joong-Sun Kim;Hyeon Hwa Nam;Ji Hye Lee
    • The Korea Journal of Herbology
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    • v.39 no.3
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    • pp.107-114
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    • 2024
  • Objective : Cicadae Periostracum (CP), which is the discarded shell of the Cryptotympana atrata (Fabricius, 1775), is a recognized component of oriental medicine for treatment sore throat, itching, shock, sedation, edema. However, the safety and toxicity of CP have not yet been established. It has been reported that symptoms of addiction or side effects may occur in patients who take high doses of CP or who are hypersensitive to it. Therefore, we investigated the acute toxicity of an CP extracts in Sprague-Dawley (SD) rats. Methods : To study acute toxicity, five SD rats of each sex per group were treated with CP extracts at single doses of 0, 500, 1000, or 2000 mg/kg administrated by oral gavage, and body weight, clinical signs, and mortality were observed after dosing. At the end of 14-day observation period, all animals were sacrificed and complete hematological and macroscopic examinations were performed. Results : There were no dead animal and test article-related effects on body weight change or the gross finding. No toxicologically significant results were observed between control and treated groups in hematology. Although salivation related to stress at the highest dose was observed in clinical signs immediately after administration, it is considered to have no toxicological significance. Conclusion : As the results, we did not find any adverse effect at the dose levels of 500, 1000, or 2000 mg/kg in rats. The minimal lethal dose was considered to be over 2000 mg/kg body weight in rats.