Bangpungtongseong-san (BPTS) Cytotoxicity and Oral Toxicity in a 4-Week Repeated Dose Test in Crl:CD (SD) Rats

Abstract

Background: Bangpungtongseong-san (BPTS) is a traditional oriental herbal prescription, with alleged antiinflammatory, antipyretic, anti-obesity, and choleretic properties that is widely used for patients in Korea, Japan, and China with obesity and hyperlipidemia resulting from long-term inappropriate lifestyle. Although BPTS is a widely used herbal prescription in Asian countries, little information is available regarding its safety and toxicity. As part of a safety evaluation of
BPTS, the present study evaluated its cytotoxicity in various cells and oral toxicity over 4 weeks through repeated administration of an aqueous extract of BPTS to Crl:CD (SD) rats.
Methods: BPTS was prepared using a water extraction method and three compounds were simultaneously isolated from BPTS using high-performance liquid chromatography. This study is the first reported evaluation of the cytotoxicity of BPTS and its repeated-dose (over 4 weeks) oral toxicity. BPTS was orally administered in daily doses of 0, 500, 1,000, and 2,000 mg/kg for 4 weeks. Cytotoxicity was conducted at various concentration ranges in BEAS-2B, LNCaP, RBL-1 cell lines, and in splenocytes.
Results: Resulting analysis of body weight gain, mortality, clinical observation, urinalysis, blood biochemistry, hematology, organ weight, and histopathological data did not show significant differences between V.CONTROL and BPTStreated groups. Additionally, we investigated the cytotoxicity of the extract against  LNCaP and splenocytes. Cytotoxic effects were observed in LNCaP cells and splenocytes, where the mean cell viability was significantly decreased at 500 g/mL and 200 g/mL of BPTS after 48 or 72 h treatment, respectively.
Conclusion: These studies found no observed adverse effects for BPTS at 2,000 mg/kg/day or less for 4 weeks repeated toxicity under the conditions of this study.