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槟榔提取物粉末在大鼠中的安全性评价:急性和180天慢性毒性试验。

Safety evaluation of Areca catechu L. extract powder in rats: acute and 180-day chronic toxicity test.

作者信息

Ma Danyang, Hou Silu, Gong Yarong, Wu Shaofeng, Hui Qiaoyue, Hao Zhihui

机构信息

Technology Innovation Center for Food Safety Surveillance and Detection (Hainan), Sanya Institute of China Agricultural University, Sanya, 572025, China; Innovation Centre of Chinese veterinary medicine, College of Veterinary Medicine, China Agricultural University, Beijing, 100193, China; National Key Laboratory of Veterinary Public Health Security, College of Veterinary Medicine, China Agricultural University, Beijing, 100193, China; Key Biology Laboratory of Chinese Veterinary Medicine, Ministry of Agriculture and Rural Affairs, Beijing, 100193, China.

Technology Innovation Center for Food Safety Surveillance and Detection (Hainan), Sanya Institute of China Agricultural University, Sanya, 572025, China; Innovation Centre of Chinese veterinary medicine, College of Veterinary Medicine, China Agricultural University, Beijing, 100193, China; National Key Laboratory of Veterinary Public Health Security, College of Veterinary Medicine, China Agricultural University, Beijing, 100193, China; Key Biology Laboratory of Chinese Veterinary Medicine, Ministry of Agriculture and Rural Affairs, Beijing, 100193, China.

出版信息

J Ethnopharmacol. 2025 Jun 26;350:119946. doi: 10.1016/j.jep.2025.119946. Epub 2025 May 9.

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE

Commonly consumed as a food in daily life, binglang (Areca catechu L.) is recognized in the Pharmacopoeia of the People's Republic of China for its anti-parasitic, digestive, and diuretic effects. Binglang extract powder (binglang tiqusan, BLTQS) is prepared from binglang through extraction, concentration, and drying processes.

AIM OF THE STUDY

To assess the acute and 180-day chronic toxicity of BLTQS following oral administration in rats.

MATERIALS AND METHODS

High performance liquid chromatography (HPLC) was employed for the analysis of arecoline in BLTQS. In the acute toxicity test, rats received a single oral dose of BLTQS at 15 g/kg body weight (bw). In the chronic toxicity test, rats were administered BLTQS at doses of 5, 15, or 30 g/kg feed for a duration of 180 days Toxicological effects were evaluated through observations of general behavior, body weight, food intake, water intake, drug intake, hematological and serum biochemical parameters, and histopathological analysis of organs.

RESULTS

HPLC effectively quantified arecoline in BLTQS (6.0 mg/g). The acute toxicity test revealed that the median lethal dose (LD) of BLTQS was >15 g/kg bw, confirming no systemic toxicity after oral administration. In the chronic toxicity test, BLTQS at 5 g/kg feed has no adverse effects, with no target organ toxicity observed. At higher doses (15 and 30 g/kg feed), no adverse effects on growth, food intake, or water intake were observed, although minor changes in hematological, serum biochemical, and histological parameters were observed.

CONCLUSIONS

The acute toxicity test showed that the LD of BLTQS exceeded 15 g/kg bw. The no-observed-effect level (NOEL) for BLTQS in rats was calculated to be 0.32 g/kg bw. These findings support the safety of BLTQS for clinical use, provided that dosages adhere to clinically recommended guidelines.

摘要

民族药理学相关性

槟榔(槟榔)在日常生活中常作为食物食用,其抗寄生虫、助消化和利尿作用在《中华人民共和国药典》中得到认可。槟榔提取物粉末(槟榔提取散,BLTQS)是通过对槟榔进行提取、浓缩和干燥工艺制备而成。

研究目的

评估大鼠口服BLTQS后的急性和180天慢性毒性。

材料与方法

采用高效液相色谱法(HPLC)分析BLTQS中的槟榔碱。在急性毒性试验中,大鼠单次口服剂量为15 g/kg体重(bw)的BLTQS。在慢性毒性试验中,大鼠以5、15或30 g/kg饲料的剂量给予BLTQS,持续180天。通过观察一般行为、体重、食物摄入量、饮水量、药物摄入量、血液学和血清生化参数以及器官组织病理学分析来评估毒理学效应。

结果

HPLC有效定量了BLTQS中的槟榔碱(6.0 mg/g)。急性毒性试验表明,BLTQS的半数致死剂量(LD)>15 g/kg bw,证实口服后无全身毒性。在慢性毒性试验中,5 g/kg饲料剂量的BLTQS无不良影响,未观察到靶器官毒性。在较高剂量(15和30 g/kg饲料)下,未观察到对生长、食物摄入或饮水的不良影响,尽管在血液学、血清生化和组织学参数上观察到轻微变化。

结论

急性毒性试验表明,BLTQS的LD超过15 g/kg bw。计算得出大鼠中BLTQS的未观察到有害作用水平(NOEL)为0.32 g/kg bw。这些发现支持了BLTQS临床使用的安全性,前提是剂量符合临床推荐指南。

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