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ABSTRACT 8
I. 서론 10
II. 재료 및 방법 11
1. Sweet BV의 조제 및 조제물의 분석 11
2. 실험동물 11
2.1. 실험동물 및 사육 환경 11
2.2. 군의 분리 12
2.3. 1회 시술 용량의 설정 12
3. 관찰 및 검사 13
3.1. 일반증상 관찰 13
3.2. 체중측정 13
3.3. 부검 13
3.4. 조직병리학적 검사 13
4. 통계처리 14
III. 결과 15
1. 개체의 사망유무 및 일반증상 관찰 15
2. 체중변화 16
3. 부검 및 조직병리학적 검사 17
IV. 고찰 18
V. 결론 23
參考文獻 25
APPENDICES 46
Appendix 1. Body weights during an acclimation period (Individual) 46
Appendix 2. Clinical signs of single intramuscular toxicity study in SD rats (Individual) 47
Appendix 3. Body weights of single intramuscular toxicity study in SD rats (Individual) 51
Appendix 4. Necropsy findings of single intramuscular toxicity study in SD rats (Individual) 53
Table 1. Mortality and approximate lethal dose of single intramuscular toxicity study in SD rats (Group summary) 40
Table 2. Clinical signs of single intramuscular toxicity study in SD rats (Group summary) 41
Table 3. Body weights of single intramuscular toxicity study in SD rats (Group summary) 43
Table 4. Necropsy findings of single intramuscular toxicity study in SD rats (Group summary) 44
Table 5. Histopathological findings of single intramuscular toxicity study in SD rats (Group summary) 45
Fig.1. Body weights of single intramuscular toxicity study in male SD rats 30
Fig.2. Body weights of single intramuscular toxicity study in female SD rats 30
Fig.3. The tissue of cerebellum 31
Fig.4. The tissue of cerebrum 32
Fig.5. The tissue of liver 33
Fig.6. The tissue of lung 34
Fig.7. The tissue of spinal cord 35
Fig.8. The tissue of left toe 36
Fig.9. Most probable conformations of melittin. 37
Fig.10. Molecular dynamics simulation of oligomeric melittin. 38
Fig.11. HPLC analysis of Sweet BV. 39
초록보기 더보기
Objectives: This study was performed to analyse single dose toxicity of pure melittin(Sweet Bee Venom - Sweet BV) extracted from the bee venom by utilizing protein isolation method of gel filtration.
Methods: All experiments were conducted at Biotoxtech, a non-clinical studies authorized institution, under the regulations of Good Laboratory Practice (GLP). Six weeks old female Sprague-Dawley rats were chosen for the pilot study and determined 30 ㎎/㎏ which is 4285 times higher than the clinical application dosage as the high dosage, followed by 15 and 7.5 ㎎/㎏ as mid and lose dosage, respectively. Equal amount of excipient to the Sweet BV experiment groups was administered as the control group.
Results:
1. No mortality was witnessed in all of the experiment groups.
2. Hyperemia and movement disorder were observed around the area of administration in all groups, and higher occurrence in the higher dosage groups. Hyperemia and movement disorder diminished with elapsed time.
3. For the weight measurement, male groups showed larger reduction in weight in accordance with higher dosage. Female groups didn't s how significant changes.
4. To verify abnormalities of organs and tissues, cerebellum, cerebrum, liver, lung, kidney, and spinal nerves were removed and conducted histological observation with H-E staining. No abnormalities were detected in any of organs and tissues.
5. One female rat in the 30 ㎎/㎏ group had amputated toe near the administered area and histopathological finding was hemorrhage with inflammation. This is presumed as a secondary infection after the administration of Sweet BV.
Conclusion: Above findings suggest Sweet BV is relatively s safe treatment medium. Further studies on the subject should be conducted to yield more concrete evidences.
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