SD(Sprague-Dawley) 랫드를 이용한 신바로 약침의 4주 반복 근육투여 독성시험 (Multiple－dose Intramuscular Toxicity Study of Shinbaro Pharmacop- uncture in Sprague-Dawley Rats over a 4－week period)

서지정보

· 발행기관 : 대한침구의학회
· 수록지 정보 : Journal of Acupuncture Research / 32권 / 4호 / 77 ~ 89페이지
· 저자명 : 이진호, 하인혁, 김미령, 김민정, 이재웅, 이인희, 정화진, 김은지

초록

Objectives: To evaluate the safety of multiple-dose intramuscular Shinbaro Pharmacopuncture in male and female Sprague-Dawley(SD) rats over a period of 4 weeks(12 sessions).
Methods: In order to test the safety of multiple-dose intramuscular Shinbaro Pharmacopuncture we used 40 healthy male and female 6-week old SD rats(male weight 171.79~196.37 g, female weight 127.93~146.43 g). Shinbaro Pharmacopuncture was administered intramuscularly to male and female SD rats at doses of 4.6 (low dose group, n＝10), 9.2 (moderate dose group, n＝10), and 18.5 mg/kg(high dose group, n＝10), respectively. General symptoms, body weight changes, blood tests, biochemical testing, necropsy, organ weight and histopathogical findings were examined over a 4-week period.
Results: 1. No mortalities or adverse effects were caused by the investigational substance were ob- served during the study period.
2. There was no significant difference in body weight caused by the the investigational sub- stance across all groups.
3. No significant between-group difference was found to be caused by the investigational substance in blood tests and biochemical testing.
4. No abnormalities were detected by a necropsy examination with the unaided eye at the macro level after treatment with the investigational substance.
5. Difference in organ weight between groups caused by the investigational substance was not found.
6. All groups did not exhibit pathological findings caused by the investigational substance in histopathogical examination.
Conclusions: According to these results, Shinbaro Pharmacopuncture has no systemic or organ toxicity with multiple-dose intramuscular administrations in male and female SD rats over a 4- week period (12 sessions). These results imply that no adverse effects are observed at a level (NOAEL) of Shinbaro Pharmacopuncture of 18.5 mg/kg.

영어초록

Objectives: To evaluate the safety of multiple-dose intramuscular Shinbaro Pharmacopuncture in male and female Sprague-Dawley(SD) rats over a period of 4 weeks(12 sessions).
Methods: In order to test the safety of multiple-dose intramuscular Shinbaro Pharmacopuncture we used 40 healthy male and female 6-week old SD rats(male weight 171.79~196.37 g, female weight 127.93~146.43 g). Shinbaro Pharmacopuncture was administered intramuscularly to male and female SD rats at doses of 4.6 (low dose group, n＝10), 9.2 (moderate dose group, n＝10), and 18.5 mg/kg(high dose group, n＝10), respectively. General symptoms, body weight changes, blood tests, biochemical testing, necropsy, organ weight and histopathogical findings were examined over a 4-week period.
Results: 1. No mortalities or adverse effects were caused by the investigational substance were ob- served during the study period.
2. There was no significant difference in body weight caused by the the investigational sub- stance across all groups.
3. No significant between-group difference was found to be caused by the investigational substance in blood tests and biochemical testing.
4. No abnormalities were detected by a necropsy examination with the unaided eye at the macro level after treatment with the investigational substance.
5. Difference in organ weight between groups caused by the investigational substance was not found.
6. All groups did not exhibit pathological findings caused by the investigational substance in histopathogical examination.
Conclusions: According to these results, Shinbaro Pharmacopuncture has no systemic or organ toxicity with multiple-dose intramuscular administrations in male and female SD rats over a 4- week period (12 sessions). These results imply that no adverse effects are observed at a level (NOAEL) of Shinbaro Pharmacopuncture of 18.5 mg/kg.

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