Toxicological evaluation of Shanzhu Tiqusan, a Garcinia mangostana pericarp-based preparation: Acute and chronic oral safety assessment in rats.

Abstract

Ethnopharmacological relevance: Garcinia mangostana L. (Shanzhu), commonly known as mangosteen, is a tropical tree traditionally used in Southeast Asia and southern China to treat diarrhea, abdominal pain, skin infections, malaria, and septicemia. Its pericarp extract, Shanzhu Tiqusan (SZTQS), is prepared through reflux extraction, spray drying, and sucrose addition.

Aim of the study: This study aimed to systematically evaluate the acute and long-term oral toxicity of SZTQS to verify its safety for potential long-term use.

Materials and methods: The α-mangostin content in SZTQS was determined by high-performance liquid chromatography (HPLC). Acute oral toxicity was evaluated in rats using a limit dose of 15 g/kg body weight, with a 14-day observation period. For chronic toxicity assessment, SZTQS was incorporated into the feed at concentrations of 2.5, 5, and 15 g/kg feed and administered continuously for 180 days. Parameters monitored throughout the study included clinical signs, body weight, food consumption, hematological and biochemical profiles, and histopathological examination of major organs.

Results: HPLC analysis revealed 34.3 mg/g α-mangostin in SZTQS. The acute study showed no mortality or toxicity at 15 g/kg BW, indicating a high safety margin. Chronic administration at 2.5 g/kg feed caused no adverse effects. At 5 g/kg feed, mild changes in blood parameters and occasional organ lesions were observed. At 15 g/kg feed, a significant reduction in body weight and feed/water intake was observed, particularly in male rats, indicating a dose-dependent toxicological effect.

Conclusions: SZTQS is non-toxic at a single oral dose exceeding 15 g/kg BW in rats. Long-term intake at 2.5 g/kg feed for 180 days was well tolerated, with a calculated no-observed-effect level (NOEL) of 0.16 g/kg BW/day based on actual intake. This corresponds to a human equivalent dose (HED) of approximately 26 mg/kg BW/day. These findings support the safety of SZTQS for potential long-term oral use in humans.