Objectives : To evaluate the safety of TA pharmacopuncture, bacterial reverse mutation test was performed using histidine requiring Salmonella typhimurium (TA98, TA100, TA1535, and TA1537) and tryptophan requiring Escherichia coli (WP2uvrA (pKM101)) strains in the absence and presence of metabolic activation. Methods : TA pharmacopuncture was prepared by extracting from a herbal mixture (Scutellariae Radix 20 g, Phellodendri Cortex 20 g, Pulsatillae Radix 20 g, Sophorae Tonkinensis Radix et Rhizoma 20 g, Aucklandiae Radix 10 g, Carthami Fructus 30 g) using a mixture solvent of purified water for injection (500 mL) and alcohol (500 mL). In order to determine the dose levels of the main study, the dose range finding study was performed. The high dose of TA pharmacopuncture was selected at 100% and it was sequentially diluted by applying a geometric ratio of 2 to produce lower dose levels of 50.0, 25.0, 12.5, and 6.25%. The treatment volume was 100 μL. As a result, the growth inhibition and precipitation of the test substance were not evident at any dose level in each strain in the absence and presence of metabolic activation. Therefore, the dose levels of the main study were selected as 100, 50.0, 25.0, 12.5, and 6.25%. Also, the negative and positive control groups were set. Results : The mean number of revertant colonies was less than twice when compared to the negative control values at all dose levels of the TA pharmacopuncture in the presence and absence of metabolic activation, showing no dose-related increase. In the positive control group, the number of revertant colonies was markedly increased by more than twice when compared to the negative control group. Conclusions : TA pharmacopuncture did not exhibit any indications of mutagenic potential under the conditions of this study.
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