Sweet Bee Venom의 비글견을 이용한 4주 반복 근육시술 독성시험
Study of four week repeated dose toxic test of Sweet Bee Venom in Beagle Dogs
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Objectives: This study was performed to analyse four week repeated 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 four week repeated dose toxicity of Sweet BV which was administered at the level of 0.56㎎/㎏ body weight which is eighty times higher than the clinical application dosage as the high dosage, followed by 0.28 and 0.14㎎/㎏ as midium and low dosage, respectively. Equal amount of excipient(normal saline) to the Sweet BV experiment groups was administered as the control group every day for four weeks. Results:1. No mortality was witnessed in all of the experiment groups. 2. All experiment groups were appealed pain sense in the treating time compared to the control group,and hyperemia and movement disorder were observed around the area of administration in all experiment groups, and higher occurrence in the higher dosage treatment. 3. For weight measurement, Neither male nor female groups showed significant changes. 4. In the urine analysis, CBC and biochemistry didn't show any significant changes in the experiment groups compared with control group. 5. For weight measurement of organs, experiment groups didn't show any significant changes compared with control group. 6. To verify abnormalities of organs and tissues, thigh muscle which treated with Sweet BV, cerebrum,liver, lung, kidney, and spinal cords were removed and conducted histologocal observation with H-E staining. In the histologocal observation of thigh muscle, cell infiltration, inflammatory,degeneration, necrosis of muscle fiber, and fibrosis were found in both thigh tissue. And the changes were depend on the dose of Sweet BV. But another organs were not detected in any abnormalities. 7. The proper high dosage of Sweet BV for the thirteen week repeated test in Beagle dogs may be 0.28㎎/㎏ in one time. Conclusion: Above findings suggest that Sweet BV is relatively safe treatment medium. Further studies on the subject should be conducted to yield more concrete evidences.
Abstract
Objectives: This study was performed to analyse four week repeated 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 four week repeated dose toxicity of Sweet BV which was administered at the level of 0.56㎎/㎏ body weight which is eighty times higher than the clinical application dosage as the high dosage, followed by 0.28 and 0.14㎎/㎏ as midium and low dosage, respectively. Equal amount of excipient(normal saline) to the Sweet BV experiment groups was administered as the control group every day for four weeks. Results:1. No mortality was witnessed in all of the experiment groups. 2. All experiment groups were appealed pain sense in the treating time compared to the control group,and hyperemia and movement disorder were observed around the area of administration in all experiment groups, and higher occurrence in the higher dosage treatment. 3. For weight measurement, Neither male nor female groups showed significant changes. 4. In the urine analysis, CBC and biochemistry didn't show any significant changes in the experiment groups compared with control group. 5. For weight measurement of organs, experiment groups didn't show any significant changes compared with control group. 6. To verify abnormalities of organs and tissues, thigh muscle which treated with Sweet BV, cerebrum,liver, lung, kidney, and spinal cords were removed and conducted histologocal observation with H-E staining. In the histologocal observation of thigh muscle, cell infiltration, inflammatory,degeneration, necrosis of muscle fiber, and fibrosis were found in both thigh tissue. And the changes were depend on the dose of Sweet BV. But another organs were not detected in any abnormalities. 7. The proper high dosage of Sweet BV for the thirteen week repeated test in Beagle dogs may be 0.28㎎/㎏ in one time. Conclusion: Above findings suggest that Sweet BV is relatively safe treatment medium. Further studies on the subject should be conducted to yield more concrete evidences.
참고문헌 (36)
- 김양강, "독성학", pp.15~18 (1984), 동화기술
- 허인회, "독성학", pp.9~186 (1993), 신일상사
- 식품의약품안정청, "식품의약품안전청고시 제2005-60호", ~
- Academic committee of KPI, "Pharmacopuncturology", Elsevier Korea, 3~199 (2008)
- Kwon KR, "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 Theraphy on the Analgesic, Anti-pyretic and Anti-inflammatory Action", Korean Journal of Oriental Medicine, 13(1), pp.283~292 (1992)
- Kwon KR, "The Effect of Bee Venom Aqua - acupuncture on the Antitumor and Immune Response in the Epithelioma by 3 - MCA", The Journal of Korean Acupuncture & Moxibustion Society, 14(2), pp.151~172 (1997)
- 이성노, "蜂藥鍼治療의 退行性膝關節炎에 대한 臨床的 考察", 대한침구학회지, 20(5), pp.73~78 (2003), 대한침구학회
- Wang WH, "Clincal Investigation Compared with the Effects of the Bee Venom - Acupuncture on Knee Joint with Osteoarthritis", The Journal of Korean Acupuncture & Moxibustion Society, 18(3), pp.35~47 (2001)
- Kim TH, "Three cases of affections of the hip treated with Korean Bee-Venom therapy", Journal of Korean Pharmacopuncture Institute, 4(3), pp.122~130 (2001)
- 이상훈, "봉독약침이 류마티스 관절염 환자관절 통증, 종창 및 급성 염증 반응에 미치는 영향", 대한침구학회지, 20(2), pp.77~84 (2003), 대한침구학회
- 이상훈, "무작위 대조 이중맹검 시험을 통한 봉독 약침의 류마티스 관절염 치료 효과 연구", 대한침구학회지, 20(6), pp.80~88 (2003), 대한침구학회
- 김경운, "요추간판탈출증에 봉약침의 근위 취혈과 근위 및 원위 취혈의 비교", 대한침구학회지, 22(6), pp.181~187 (2005), 대한침구학회
- 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", 한침구학회지, 21(5), pp.13~26 (2004), 대한침구학회
- 전형준, "봉약침으로 치료한 요추간판탈출증 환자의 임상적 평가", 대한침구학회지, 20(5), pp.63~72 (2003), 대한침구학회
- 이대용, "中風後遺症으로 인한 肩臂痛 患者의 蜂藥鍼治療에 대한 臨床的 考察", 대한침구학회지, 23(4), pp.69~80 (2006), 대한침구학회
- 정경숙, "뇌졸중 후 중추성 통증 환자에 대한 봉독약침요법 치료 효과에 대한 임상적 연구", 대한침구학회지, 22(3), pp.69~76 (2005), 대한침구학회
- 최영권, "Gel filtration chromatography와 propionic acid", urea polyacrylamide gel electrophoresis를 이용한 봉독 성분의 분리, 2006, pp.9(2), 105~111[DOI]
- Barbara, "Chemistry and Pharmacology of Honey Bee venom", pp.329~402 (1986), Academic Press
- Park HJ, "Antiarthritic effect of Bee Venom", Arthritis & Rheumatism, 50(11), pp.3504~3515 (2004)
- Park HJ, "JNK pathway is involved on the inhibition of inflammatory target gene expression and NF-κB activation by melittin", J. Inflammation, 5(7), pp.1~13 (2008)
- 김영진, "Sweet BV의 rat를 이용한 단회 근육시술 독성시험", 대한약침학회지, 12(4), pp.5~32 (2009), 대한약침학회
- 식품의약품안정청, "식품의약품안전청고시 제2008-56호", ~
- 이상인, "본초학", pp.4~5 (1985), 수서원
- 강계성, "다발성 경화증 환자 5례에 대한 임상보고", 대한침구학회지, 20(1), pp.209~217 (2003), 대한침구학회
- 권기록, "한방치료를 통한 근위축성 측삭경화증(ALS)의 임상적 연구", 대한침구학회지, 20(3), pp.209~216 (2003), 대한침구학회
- Lee JS, "A Clinical Study on the case of Fascioscapulohumeral ( FSH ) Muscular Dystrophy Treated with Traditional Korean Medicine", The Journal of Korean Acupuncture & Moxibustion Society, 18(3), pp.227~238 (2001)
- Hwang YJ, "Clinical Study of Anaphylaxis on Bee-Venom Acupuncture", The Journal of Korean Acupuncture & Moxibustion Society, 17(4), pp.149~159 (2000)
- 윤현민, "봉약침요법으로 발생한 Anaphylaxis에 대한 임상보고", 대한침구학회지, 22(4), pp.179~188 (2005), 대한침구학회
- Robert L, "Allergy, Hypersensitivity, Anaphylaxis. Emergency Medicine", pp.2759~2766 (1998), Mosby Year Book
- 권기록, "Sweet BV의 함량분석과 시술 부위별 LD50관찰", 대한약침학회지, 10(2), pp.81~86 (2007), 대한약침학회
- 권기록, "Sweet BV의 성분분석과 항체역가 및 allergy 반응에 대한 임상적 연구", 대한약침학회지, 9(2), pp.79~86 (2006), 대한약침학회
- 이진선, "봉약침(Bee Venom)과 Sweet Bee Venom의 Allergy 반응에 대한 비교연구", 대한약침학회지, 9(3), pp.61~77 (2006), 대한약침학회
- Renata MS, "Structural and functional behavior of biologically active monomeric melittin", J Molecular Graphics and Modelling, 25, pp.767~772 (2007)
- Lind DS, "Mishra G, et al. nuclear factor-κB is upregulated in colorectal cancer", Surgery, 130, pp.363~369 (2001)
- Aranha MM, "NF-κB and apotosis in colorectal tumorigenesis", Eur J Clin Invest, 37, pp.416~424 (2007)