Jamadagni Pallavi S, Jamadagni Shrirang B, Singh Rajendrakumar, Gaidhani Sudesh N, Upadhyay Sachchidanand, Hazra Jayram
Research Officer (Pharmacology), National Research Institute of Ayurveda for Drug Development, Kolkata, West Bengal, India.
Ayu. 2013 Jan;34(1):118-23. doi: 10.4103/0974-8520.115449.
Trivanga Bhasma, a metallic preparation containing Bhasmas of Naga (lead), Vanga (tin) and Yashada (zinc), was studied for repeated dose toxicity in Swiss albino mice to estimate No Observed Effect Level (NOEL) or No Observed Adverse Effect Level (NOAEL). A total of 80 Swiss albino mice of either sex with an average body weight of 28-30 g were equally divided into four groups (Group I, II, III, and IV). Group I served as control and was given vehicle (honey: water in 2:3 ratio) Group II, III, and IV received Trivanga Bhasma @ 7.8, 39.5,and 78 mg/kg body weight for 90 consecutive days. The effect of drug was assessed on body weight, feed and water consumption changes, hematological, and histopathological parameters. At the end of the study, all animals were sacrificed and examined for gross pathological changes. Histopathological evaluation was performed for control and high dose group. Trivanga Bhasma was found to be safe. No significant clinical signs were noted in all groups studied. No major alterations were observed during histopathological evaluation. Hence, dose rate of 78 mg/kg body weight was established as NOAEL. It is suggested to carry out a toxicity study at possible higher doses and in a different species so as to establish target organ of toxicity.
三味煅灰制剂是一种含有那伽（铅）、万加（锡）和雅沙达（锌）煅灰的金属制剂，对瑞士白化小鼠进行了重复给药毒性研究，以评估无观察到效应水平（NOEL）或无观察到不良反应水平（NOAEL）。总共80只平均体重为28 - 30克的瑞士白化小鼠，雌雄各半，被平均分为四组（第一组、第二组、第三组和第四组）。第一组作为对照组，给予赋形剂（蜂蜜：水，比例为2:3）；第二组、第三组和第四组连续90天分别接受7.8、39.5和78毫克/千克体重的三味煅灰制剂。评估药物对体重、饲料和水消耗变化、血液学和组织病理学参数的影响。在研究结束时，处死所有动物并检查大体病理变化。对对照组和高剂量组进行了组织病理学评估。发现三味煅灰制剂是安全的。在所研究的所有组中均未观察到明显的临床症状。在组织病理学评估期间未观察到重大改变。因此，确定78毫克/千克体重的剂量率为无观察到不良反应水平。建议在可能的更高剂量下并在不同物种中进行毒性研究，以确定毒性靶器官。
