Abstract
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 observed during the study period. 2. There was no significant difference in body weight caused by the the investigational substance 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.
