Niyomchan Apichaya, Chatgat Wasapon, Chatawatee Bodin, Keereekoch Thaweeporn, Issuriya Acharaporn, Jaisamut Patcharawalai, Chusri Sasitorn, Kunworarath Nongluk
Department of Anatomy, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand.
Faculty of Traditional Thai Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.
Evid Based Complement Alternat Med. 2023 Jul 24;2023:9413458. doi: 10.1155/2023/9413458. eCollection 2023.
NawaTab is a tablet formulation developed from the Nawametho polyherbal formula used in Surat Thani province, Southern Thailand, for the treatment of hyperlipidemia. This study aims at evaluating the acute and subacute toxicity of NawaTab in rats. In the acute toxicity study, NawaTab was evaluated in female rats following the OECD Guideline No. 423. In the subacute toxicity study, NawaTab was tested in both male and female rats following the OECD Guideline No. 407. In the acute toxicity study, no lethal effects or toxic signs were observed during the duration of the study. In the subacute toxicity study, there was no mortality and no abnormality in clinical signs, body weight, food consumption, relative organ weight, and hematological parameters of NawaTab-treated rats. Significantly increased water consumption by male rats (500 mg/kg BW) and female rats (250, 500, and 1000 mg/kg BW) was observed. In addition, globulin and total cholesterol of female rats (1000 mg/kg BW) significantly increased. These alterations were within normal physiological ranges. Moreover, necropsy and histopathological findings of NawaTab-treated rats demonstrated no obvious alterations attributable to NawaTab administration. The present study revealed that NawaTab has no significant acute oral toxicological effects. The lethal dose with a 50% mortality rate (LD) was higher than 5000 mg/kg BW in rats. The subacute oral administration of NawaTab for 28 days did not have any major toxicological effects. Based on this study, NawaTab could be safe to use with caution pending its chronic toxicity study.
纳瓦塔布（NawaTab）是一种片剂制剂，它源自泰国南部素叻他尼府用于治疗高脂血症的纳瓦梅托（Nawametho）多草药配方。本研究旨在评估纳瓦塔布对大鼠的急性和亚急性毒性。在急性毒性研究中，按照经济合作与发展组织（OECD）第423号指南对雌性大鼠进行了纳瓦塔布的评估。在亚急性毒性研究中，按照OECD第407号指南对雄性和雌性大鼠都进行了纳瓦塔布的测试。在急性毒性研究中，在研究期间未观察到致死效应或毒性迹象。在亚急性毒性研究中，接受纳瓦塔布治疗的大鼠在临床体征、体重、食物消耗、相对器官重量和血液学参数方面均未出现死亡和异常情况。观察到雄性大鼠（500 mg/kg体重）以及雌性大鼠（250、500和1000 mg/kg体重）的饮水量显著增加。此外，雌性大鼠（1000 mg/kg体重）的球蛋白和总胆固醇显著升高。这些变化均在正常生理范围内。而且，对接受纳瓦塔布治疗的大鼠进行尸检和组织病理学检查未发现因给予纳瓦塔布而导致的明显改变。本研究表明，纳瓦塔布没有明显的急性经口毒理学效应。大鼠的半数致死剂量（LD）高于5000 mg/kg体重。纳瓦塔布连续28天经口亚急性给药未产生任何重大毒理学效应。基于本研究，在其慢性毒性研究之前，谨慎使用纳瓦塔布可能是安全的。
