ĐÁNH GIÁ ĐỘC TÍNH CẤP CỦA CAO LỎNG LINH CHI – ĐAN SÂM TRÊN CHUỘT NHẮT TRẮNG

Abstract

Background: Ganoderma lucidum (Reishi) and Salvia miltiorrhiza (Danshen) are two traditional medicinal herbs commonly used in Traditional Medicine for tonifying qi and blood, as well as promoting blood circulation and resolving blood stasis. Pharmacological studies have demonstrated that polysaccharides and triterpenoids from Ganoderma lucidum, along with salvianolic acid B and tanshinones from Salvia miltiorrhiza, exhibit immunomodulatory, antioxidant, and hepatoprotective activities. However, scientific data regarding the safety of combined formulations of these two herbs remain limited, particularly in preclinical toxicity evaluation. Objectives: To assess the acute oral toxicity and preliminarily establish the preclinical safety profile of a combined extract of Ganoderma lucidum and Salvia miltiorrhiza in mice. Materials and methods:  This was a preclinical experimental study. The formulation was qualitycontrolled according to the Vietnamese Pharmacopoeia V. The liquid extract was prepared from Ganoderma lucidum and Salvia miltiorrhiza at a 1:1 ratio (based on dry raw material weight), extracted twice with water and concentrated to achieve a final concentration equivalent to 2 g of dried medicinal material per mL. The highest tested dose was 14.1 g/kg body weight, corresponding to three times the human-equivalent dose converted according to the Vietnamese Ministry of Health guideline. The study was conducted in accordance with the Ministry of Health guidelines and with reference to OECD principles. Animals were monitored for mortality and clinical signs over a 14day period (with the first 72 hours considered critical). Body weight was recorded at 0, 24, and 72 hours. On day 14, hematological parameters, biochemical indices (AST, ALT, urea, creatinine), and histopathological examinations of the liver and kidneys were evaluated. Results: No mortality was observed at any tested dose during the 14-day observation period. No adverse clinical, hematological or biochemical effects were observed. Gross and microscopic structures of the liver and kidneys were preserved. Conclusion: The oral LD₅₀ could not be determined under the present experimental conditions and was considered to be greater than 14.1 g/kg body weight.