Baskar Rajamanickam, Bharathkumar Govindaraju, Manekshah Yovas Rajammal, Selvapriya Sikkal Selvaraaju, Devi Thangarasu Hema, Bharathi Selvaraj, Kavitha Kuppuswamy, Rajalakshmi Arumugam, Ramesh Balasubramanian
Department of Gunapadam (Pharmacology), Government Siddha Medical College, The Tamil Nadu Dr.MGR Medical University, Chennai, 600106, Tamil Nadu, India.
Department of Siddha, The Tamil Nadu Dr. MGR Medical University, Chennai, 600 032, Tamil Nadu, India.
Protoplasma. 2025 Apr 3. doi: 10.1007/s00709-025-02056-y.
Madhumukthi Kudineer Chooranum (MKC) is a decoction from polyherbal Siddha formulation for managing diabetes. The safety of this formulation has not been reported earlier. This study evaluates the chronic toxicity of the Siddha herbal formulation MKC in experimental Sprague-Dawley (SD) rats. In an acute oral toxicity study, male and female SD rats were orally administered a single dose of MKC (2000 mg/kg), and clinical signs and mortality stages were observed for 14 days along with weekly body weight. On day 15, the rats were euthanized and the gross morphology was carried out during necropsy. In a chronic (repeated dose) oral toxicity study, the male and female rats were orally administered MKC (200, 400, and 800 mg/kg) once daily for up to 180 days. MKC showed outstanding tolerance in SD rats with a NOAEL of 2000 mg/kg, with no adverse effects or death during the study. In acute and chronic toxicity trials, MKC did not alter parameters or cause harmful effects. No group died or became moribund in either study.
马杜穆克蒂古迪内尔煎剂(MKC)是一种用于治疗糖尿病的 Siddha 多草药配方煎剂。此前尚未报道过该配方的安全性。本研究评估了 Siddha 草药配方 MKC 对实验性斯普拉格-道利(SD)大鼠的慢性毒性。在急性经口毒性研究中,对雄性和雌性 SD 大鼠经口单次给予 MKC(2000 mg/kg),观察 14 天的临床症状和死亡阶段,并每周测量体重。在第 15 天,对大鼠实施安乐死,并在尸检时进行大体形态学检查。在慢性(重复给药)经口毒性研究中,雄性和雌性大鼠每天经口给予 MKC(200、400 和 800 mg/kg),持续 180 天。MKC 在 SD 大鼠中表现出显著的耐受性,无观察到有害作用水平(NOAEL)为 2000 mg/kg,研究期间无不良反应或死亡。在急性和慢性毒性试验中,MKC 未改变参数或造成有害影响。在两项研究中,均无动物死亡或濒死。