Study of a 13-weeks, Repeated, Intramuscular Dose, Toxicity Test of Sweet Bee Venom in Sprague-Dawley Rats
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Objectives: This study was performed to analyze a 13-week repeated dose toxicity test of Sweet Bee Venom (SBV) extracted from bee venom and administered in Sprague-Dawley (SD) rats. Methods: Male and female 5-week-old SD rats were treated once daily with SBV (high-dosage group: 0.28 mg/kg; medium-dosage group: 0.14 mg/kg; or low-dosage group: 0.07 mg/kg) for 13 weeks. Normal saline was administered to the control group in a similar manner (0.2 mL/kg). We conducted clinical observations, body weight measurements, ophthalmic examinations, urinalyses, hematology and biochemistry tests, and histological observations using hematoxylin and eosin (H&E) staining to identify any abnormalities caused by the SBV treatment. Results: During this study, no mortality was observed in any of the experimental groups. Hyperemia and a movement disorder were observed around the area of in all groups that received SBV treatment, with a higher occurrence in rats treated with a higher dosage. Male rats receiving in the high-dosage group showed a significant decrease in weight during the treatment period. Compared to the control group, no significant changes in the ophthalmic parameters, the urine analyses, the complete blood cell count (CBC), and the biochemistry in the groups treated with SBV. Compared to the control group, some changes in organ weights were observed in the medium-and the high-dosage groups, but the low-dosage group showed no significant changes. Histological examination of thigh muscle indicated cell infiltration, inflammation, degeneration, and necrosis of muscle fiber, as well as fibrosis, in both the medium- and the high-dosage groups. Fatty liver change was observed in the periportal area of rats receiving medium and high dosages of SBV. No other organ abnormalities were observed. Conclusion: Our findings suggest that the NOAEL (No Observed Adverse Effect Level) of SBV is approximately 0.07 mg/kg in male and female SD rats.
Abstract
Objectives: This study was performed to analyze a 13-week repeated dose toxicity test of Sweet Bee Venom (SBV) extracted from bee venom and administered in Sprague-Dawley (SD) rats. Methods: Male and female 5-week-old SD rats were treated once daily with SBV (high-dosage group: 0.28 mg/kg; medium-dosage group: 0.14 mg/kg; or low-dosage group: 0.07 mg/kg) for 13 weeks. Normal saline was administered to the control group in a similar manner (0.2 mL/kg). We conducted clinical observations, body weight measurements, ophthalmic examinations, urinalyses, hematology and biochemistry tests, and histological observations using hematoxylin and eosin (H&E) staining to identify any abnormalities caused by the SBV treatment. Results: During this study, no mortality was observed in any of the experimental groups. Hyperemia and a movement disorder were observed around the area of in all groups that received SBV treatment, with a higher occurrence in rats treated with a higher dosage. Male rats receiving in the high-dosage group showed a significant decrease in weight during the treatment period. Compared to the control group, no significant changes in the ophthalmic parameters, the urine analyses, the complete blood cell count (CBC), and the biochemistry in the groups treated with SBV. Compared to the control group, some changes in organ weights were observed in the medium-and the high-dosage groups, but the low-dosage group showed no significant changes. Histological examination of thigh muscle indicated cell infiltration, inflammation, degeneration, and necrosis of muscle fiber, as well as fibrosis, in both the medium- and the high-dosage groups. Fatty liver change was observed in the periportal area of rats receiving medium and high dosages of SBV. No other organ abnormalities were observed. Conclusion: Our findings suggest that the NOAEL (No Observed Adverse Effect Level) of SBV is approximately 0.07 mg/kg in male and female SD rats.
참고문헌 (23)
- Korean Pharmacopuncture, Institute, "Pharmacopuncturology: principles and clinical applications", pp.147~149 (2012), Elsevier Korea LLC
- 이성노, "蜂藥鍼治療의 退行性膝關節炎에 대한 臨床的 考察", 대한침구의학회지, 20(5), pp.6~81 (2003), 대한침구의학회
- 왕오호, "Clinical investigation compared with the effects of the bee-venom Acupuncture on knee joint with osteoarthritis", Journal of Pharmacopuncture, 4(3), pp.101~103 (2001), 대한약침학회[DOI]
- 권기록, "Three cases of affections of the hip treated with Korean Bee-Venom therapy", Journal of Pharmacopuncture, 4(3), pp.127~134 (2001), 대한약침학회[DOI]
- 이상훈, "봉독약침이 류마티스 관절염 환자의 관절 통증, 종창 및 급성 염증 반응에 미치는 영향", 대한침구의학회지, 20(2), pp.7~84 (2003), 대한침구의학회
- 이상훈, "무작위 대조 이중맹검 시험을 통한 봉독 약침의 류마티스 관절염 치료 효과 연구", 대한침구의학회지, 20(6), pp.9~88 (2003), 대한침구의학회
- 김경운, "요추간판탈출증에 봉약침의 근위 취혈과 근위 및 원위 취혈의 비교", 대한침구의학회지, 22(6), pp.181~187 (2005), 대한침구의학회
- 이건목, "蜂藥鍼을 위주로 한 腰椎椎間板脫出症 의 突出型 患者(protrusion disc patients) 에 대한 臨床的 考察", 대한침구의학회지, 21(5), pp.13~26 (2004), 대한침구의학회
- Habermann E., "Bee and wasp venoms", Science, 177(4046), pp.314~322 (1972)
- Gauldie J., "The Peptide Components of Bee Venom", Eur. J. Biochem, 61(2), pp.369~376 (1976)
- 이진선, "봉약침(Bee Venom)과 Sweet Bee Venom의 Allergy 반응에 대한 비교연구", Journal of Pharmacopuncture, 9(3), pp.61~77 (2006), 대한약침학회
- 권기록, "Sweet BV의 함량분석과 시술 부위별 LD50관찰", Journal of Pharmacopuncture, 10(2), pp.81~86 (2007), 대한약침학회
- Kwon KR., "An experimental study with bee venom therapy on anti-inflammatory and analgesic effects", The Journal of Korean Acupuncture & Moxibustion Society, 15(2), pp.97~103 (1998)
- Ko HK., "Experimental studies on the effect of bee venom therapy on the analgesic, anti-pyretic and anti-inflammatory action", Korean Journal of Oriental Medicine, 13(1), pp.283~292 (1992)
- 김영진, "Sweet BV의 rat를 이용한 단회 근육시술 독성시험", Journal of Pharmacopuncture, 12(4), pp.5~32 (2009), 대한약침학회
- 윤휘철, "Sweet Bee Venom의 비글견을 이용한 단회근육시술 독성시험", Journal of Pharmacopuncture, 13(4), pp.43~62 (2010), 대한약침학회
- 권혜연, "Sweet Bee Venom의 rat를 이용한 4주 반복 근육시술 독성시험", Journal of Pharmacopuncture, 14(1), pp.5~24 (2011), 대한약침학회
- 박재석, "Sweet Bee Venom의 비글견을 이용한 4주 반복 근육시술 독성시험", Journal of Pharmacopuncture, 13(4), pp.5~42 (2010), 대한약침학회
- Bartlett MS., "Properties of sufficiency and statistical test", Pros R Soc London A, 160(901), pp.268~282 (1937)
- Dunnett CW., "New tables for multiple comparisons with control", Biometrics, 20(3), pp.482~491 (1964)
- 권기록, "Sweet BV의 성분분석과 항체역가 및 allergy 반응에 대한 임상적 연구", Journal of Pharmacopuncture, 9(2), pp.79~86 (2006), 대한약침학회
- 최영권, "Gel filtration chromatography와 propionic acid", urea polyacrylamide gel electrophoresis를 이용한 봉독 성분의 분리, 2006, pp.9(2), 105~111[DOI]
- 안중철, "봉독과 Sweet Bee Venom의 항균 및 항산화능 비교연구", Journal of Pharmacopuncture, 9(3), pp.97~104 (2006), 대한약침학회