@article {2497, title = {Acute and Subchronic Toxicity Study of Sampilnorov Wurile}, journal = {Pharmacognosy Journal}, volume = {17}, year = {2025}, month = {April 2025}, pages = {203-210}, type = {Original Article}, chapter = {203}, abstract = {

Introduction: Sampilnorov Wurile (SW) is a traditional medicinal preparation containing 29 plant-, mineral-, and animal-derived components. It is used for cerebrovascular ischemia, retinal disorders, cardiovascular diseases, and neurological conditions. This study aimed to evaluate the acute and subchronic toxicities of SW. Methods: Acute toxicity was assessed in C57BL/6 mice based on OECD-423 guidelines, with oral doses ranging from 500 to 6,000 mg/kg body weight. Subchronic toxicity was evaluated in Wistar rats following OECD-407 guidelines, with daily oral doses of 300 and 600 mg/kg of SW daily for 4 weeks. Clinical signs, mortality, body weight, and physical condition were monitored. Hematological, biochemical, and histopathological analyses were conducted on day 29. Results: No mortality or significant clinical signs of toxicity were observed at doses up to 6,000 mg/kg, suggesting an oral median lethal dose exceeding this level. Subchronic toxicity assessment revealed no clinical signs of toxicity or mortality. SW at 300 and 600 mg/kg had no significant effects on serum biochemical parameters or vital organ histology compared to controls. Conclusion: SW exhibited no acute toxicity at doses up to 6,000 mg/kg and showed no adverse effects in a 28-d subchronic toxicity study. These findings support its safety at tested doses.

}, keywords = {Acute and subchronic toxicity; biochemistry; blood test; histopathological analysis; Sampilnorov Wurile}, doi = {10.5530/pj.2025.17.25}, author = {Li ChangSheng and Chimgee Tserendash and Maral-Erdene Gerelt-Od and Batdavaa Batbayar and Uyangamaa Altankhuyag and Mend-Amar Batbaatar and Narankhajid Myadagsuren and Davaadagva Damdinjav and Enkhmaa Gonchig and Yeruult Chultemsuren} } @article {2573, title = {Preclinical Safety Assessment of a Polyherbal Formulation: Acute, Subchronic, and Mutagenic Evaluation}, journal = {Pharmacognosy Journal}, volume = {17}, year = {2025}, month = {December 2025}, pages = {322-328}, type = {Original Article}, chapter = {322}, abstract = {

Introduction: Before market approval, novel herbal medicines and bioactive compounds require rigorous genotoxicity and safety evaluations. A polyherbal formulation derived from Dasiphora fruticosa, Cynara scolymus, and Rosa acicularis has previously demonstrated antioxidant and nephroprotective properties. However, comprehensive toxicological and mutagenicity evaluations are needed to support its clinical development. In this study, we aimed to evaluate the acute and subchronic toxicities and mutagenic potential of this polyherbal formulation. Methods: Acute oral toxicity was assessed in C57BL/6 mice using a two-phase protocol based on Lorke{\textquoteright}s method. Subchronic toxicity was evaluated in Wistar rats following OECD guideline 407, with daily oral administration of the polyherbal formulation at doses of 500 and 1,000 mg/kg for 28 days. Mutagenicity was assessed using the Muta-Chromoplate (Ames test) kit according to OECD guideline 471. Results: Acute toxicity evaluation determined that the median lethal dose (LD50) of the polyherbal formulation exceeds 5,000 mg/kg, categorising it as practically nontoxic. The subchronic toxicity assessment revealed that doses of 500 and 1,000 mg/kg had no significant effects on body and organ weight, haematological and biochemical parameters, and histopathological features compared with the controls. Furthermore, the Ames test confirmed that the polyherbal formulation had no mutagenic activity. Conclusions: The polyherbal formulation exhibited no acute toxicity at doses up to 5,000 mg/kg, and no adverse effects were observed in a 28-day subchronic toxicity study. Furthermore, its favourable safety profile was further confirmed by its lack of mutagenic potential. Collectively, these findings provide a robust foundation for continued preclinical and clinical development of the polyherbal formulation

}, keywords = {acute toxicity; mutagenicity; phytochemicals; polyherbal formulation; safety evaluation; subchronic toxicity}, doi = {10.5530/pj.2025.17.102}, author = {Enkhmaa Gonchig and Chimgee Tserendash and Maral-Erdene Gerelt-Od and Batdavaa Batbayar and Mend-Amar Batbaatar and Perleidulam Bunddulam and Enerel Yeruult and Narankhajid Myadagsuren and Otgonbat Altangerel and Yeruult Chultemsuren} }