Assessment of the Toxicity and the Stability of Saeng Mak San by Using Repeated Intravenous Injections in Sprague-Dawley Rats.
OBJECTIVE
This study used repeated intravenous injections of Saeng Maek San (SMS) injection in Sprague-Dawley (SD) rats to assess the toxicity and the stability of SMS.


METHODS
Six-week-old male and female SD rats reared by Orient bio Inc were chosen for this pilot study. They were randomly split into four groups: Group 1 (G1), the control group (0.3 mL of normal saline solution/day/animal), and Groups 2, 3 and 4 (G2, G3 and G4), the experimental groups (0.1, 0.2 and 0.3 mL/day/animal of SMS), respectively. Each animal received an intravenous injection of SMS once a day for four weeks. Clinical signs, body weight changes, and food consumption were monitored during the observation period, and urinalysis and hematology were conducted after four weeks of SMS or saline administration.


RESULTS
No deaths occurred in any of the four groups during the observation period. Compared to the control group, male and female rats in groups 3 and 4 (0.2 and 0.3 mL/animal/day) showed hemoglobinuria, but the low-dosage group (G2, 0.1 mL/animal/day) showed no significant changes in the clinical signs test. No significant changes due to SMS were observed in the experimental groups regarding body weight changes, food consumption urinalysis, or hematology.


CONCLUSIONS
During this study, no mortalities were observed in any of the experimental groups and no hemoglobinuria was observed in the low dosage group (0.1 mL/animal/day) while it was intermittently observed in groups 3 and 4 (0.2 and 0.3 mL/animal/day). Thus, we suggest that the no-observed adverse-effect level (NOAEL) is 0.1 mL/animal/day in male and female SD rats.
Department of Neuropsychiatry, Hospital of Korean Medicine, Kyung-Hee University Medical Center, Kyung-Hee University, Seoul, Korea.
Hwa-Young
HY
Lee
ALS/MND Center of Wonkwang University, Gwangju, Korea.
Sungchul
S
Kim
Department of Neuropsychiatry, Hospital of Korean Medicine, Kyung-Hee University Medical Center, Kyung-Hee University, Seoul, Korea.
Seung-Hun
SH
Cho
 Saeng Maek San;  pharmacopuncture;  toxicity test; intravenous injection
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