Abstract
Objectives : The contents of aconitine in aconiti radix lateralis preparata, purified hot water extract of Aconiti Radix lateralis preparata, and purified hot water extract of Sambutang-P that contains Aconiti Radix lateralis preparata was analyzed to compare toxicity. Toxicity of Sambutang-P that contains Aconiti Radix lateralis preparata was assessed with a single oral toxicity test on 6-week-old male and female Sprague-Dawley rats. Methods : 1. The contents of aconitine in Aconiti Radix lateralis preparata, purified hot water extract of Aconiti Radix lateralis preparata, and purified hot water extract of Sambutang-P that contains Aconiti Radix lateralis preparata was analyzed using the purity test according to the "Korean Herbal Pharmacopoeia". 2. 2,000mg/kg was injected for the single oral toxicity test of purified hot water extract of Sambutang-P that contains Aconiti Radix lateralis preparata, and the test was done for a test group (injection) and a control group, each with 5 male and 5 female rats. For 14 days after injection, rats were observed for general symptoms and changes in weight. Afterwards, blood biochemical test, autopsy, and histophathological exam of the liver was conducted. Results : 1. The contents of aconitine was 0.0785% for Aconiti Radix lateralis preparata, 0.1510% for purified hot water extract of Aconiti Radix lateralis preparata, and 0.1248% for purified hot water extract of Sambutang-P that contains Aconiti Radix lateralis preparata. 2. There was no death of either male or female rats in both the control group and the test group (injection of 2,000mg/kg). 3. No unusual symptom was observed in both the control group and the test group (injection of 2,000mg/kg). 4. No significant change in weight was observed for both male and female rats in the test group (2,000mg/kg). 5. The histopathological exam of ALT, AST, ALP, GGT and LDH showed no significant changes for both male and female rats in the test group (2,000mg/kg). 6. According to the autopsy results, no visible abnormality of organs or tissues was found in both the control group and the test group (2,000mg/kg). 7. According to the histopathological exam of the liver, the effect of the injected material was not observed for either male or female rats in the test group (2,000mg/kg). Conclusions : The contents of aconitine in Aconiti Radix lateralis preparata was lower for decoction of Sambutang-P with ginseng radix alba than for decoction of only Aconiti Radix lateralis preparata. This suggests that ginseng radix alba can dilute toxicity of Aconiti Radix lateralis preparata. As for a single oral toxicity test of Sambutang-P that contains Aconiti Radix lateralis preparata, no abnormal reaction was observed even when the injection amount far exceeded a toxic dose or a lethal dose. Thus, it is deemed that using Sambutang-P at a clinically prescribed dose would not lead to hepatoxicity.
