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一种复方草药制剂的无害性:使用传统泰式降压草药配方在啮齿动物中的案例研究。

Innocuousness of a polyherbal formulation: A case study using a traditional Thai antihypertensive herbal recipe in rodents.

机构信息

Department of Pharmacognosy, Faculty of Pharmacy, Rangsit University, Lak-Hok, Muang, Pathum Thani, 12000, Thailand.

Department of Pharmacology, Faculty of Science, Prince of Songkla University, Hat Yai, Songkhla, 90112, Thailand.

出版信息

Food Chem Toxicol. 2018 Feb;112:458-465. doi: 10.1016/j.fct.2017.07.052. Epub 2017 Jul 28.

Abstract

Recently, a traditional Thai antihypertensive herbal recipe has reportedly been used in Thailand. Its ingredients have long featured in traditional Thai medicine preparations; however, research indicates that the presence of one of them - Tinospora crispa - may have negative effects on the liver and kidneys. Thus, the safety data of this recipe must be proved in animal models prior to conducting any studies in humans. The present case study aims to evaluate the safety of this recipe in Swiss albino mice and Wistar rats through acute and sub-chronic toxicity studies, respectively. The quality control of this recipe was also achieved to guarantee the chemical consistency throughout the entire experiment. Results showed that this recipe did not cause death or any toxic signs in mice or rats. The oral LD50 value in mice was more than 5.0 g/kg. Some hematological and serum biochemical values of treated rats, such as hematocrit, hemoglobin, platelet, monocytes, aspartate aminotransferase, bilirubin, and creatinine, were found to be statistically different from the control group; however, all values were within the ranges of normal rats. Considering the histological study, no damage on liver and kidney tissues was observed in the treatment.

摘要

最近,据报道,泰国使用了一种传统的泰式降压草药配方。其成分长期以来一直是泰式传统药物制剂的特色;然而,研究表明,其中一种成分——三叶鬼针草(Tinospora crispa)可能对肝脏和肾脏有不良影响。因此,在进行任何人体研究之前,必须在动物模型中证明该配方的安全性数据。本病例研究旨在通过急性和亚慢性毒性研究分别评估该配方在瑞士白化小鼠和 Wistar 大鼠中的安全性。该配方的质量控制也得到了保证,以确保整个实验过程中的化学成分一致性。结果表明,该配方在小鼠或大鼠中未引起死亡或任何毒性迹象。在小鼠中的口服 LD50 值大于 5.0 g/kg。一些接受治疗的大鼠的血液学和血清生化值,如红细胞压积、血红蛋白、血小板、单核细胞、天冬氨酸转氨酶、胆红素和肌酐,与对照组相比存在统计学差异;然而,所有值均在正常大鼠的范围内。考虑到组织学研究,在治疗中未观察到肝和肾组织损伤。

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