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大鼠厚朴树皮提取物的短期和亚慢性毒性评价。

Evaluation of short-term and subchronic toxicity of magnolia bark extract in rats.

作者信息

Liu Zhaoping, Zhang Xiaopeng, Cui Wenming, Zhang Xin, Li Ning, Chen Junshi, Wong Andrea W, Roberts Ashley

机构信息

Department of Toxicological Safety Assessment, National Institute for Nutrition and Food Safety, Chinese Center for Disease Control and Prevention, Beijing, China.

出版信息

Regul Toxicol Pharmacol. 2007 Dec;49(3):160-71. doi: 10.1016/j.yrtph.2007.06.006. Epub 2007 Jul 4.

Abstract

Magnolia bark has been traditionally used in Chinese and Japanese medicines, and its extract is a constituent of currently marketed dietary supplements and cosmetic products. The safety of magnolia bark extract (MBE) was assessed in short-term and subchronic studies. In a 21-day pilot study, rats were administered MBE at levels of 0, 60, 120, 240 or 480 mg/kg body weight (bw)/day in the diet. There were no treatment-related effects in clinical observations, macroscopic or microscopic findings, hematological, clinical chemistry, urinalysis, or organ weight measurements, and there were no deaths or significant differences in body weight and weight gain. In the 90-day study, rats were administered 0, 60, 120 or 240 mg MBE/kg bw/day in the diet. No mortality, ophthalmic abnormalities or treatment-related findings in clinical observations, hematology, coagulation or organ weight measurements were observed. There were no treatment-related macroscopic or microscopic findings. Differences between treated and control groups in body weight, weight gain, food consumption and utilization, clinical chemistry and urinalysis parameters were not considered toxicologically significant as they were not dose-related and/or because values remained within historical control ranges. These results support the safety of MBE for oral consumption.

摘要

厚朴传统上用于中药和日本药,其提取物是目前市售膳食补充剂和化妆品的成分之一。在短期和亚慢性研究中评估了厚朴树皮提取物(MBE)的安全性。在一项为期21天的初步研究中,给大鼠喂食含0、60、120、240或480毫克/千克体重(bw)/天的MBE饲料。在临床观察、大体或显微镜检查结果、血液学、临床化学、尿液分析或器官重量测量方面,未发现与治疗相关的影响,且无死亡情况,体重和体重增加也无显著差异。在为期90天的研究中,给大鼠喂食含0、60、120或240毫克MBE/千克bw/天的饲料。在临床观察、血液学、凝血或器官重量测量中,未观察到死亡、眼部异常或与治疗相关的结果。未发现与治疗相关的大体或显微镜检查结果。治疗组和对照组在体重、体重增加、食物消耗和利用率、临床化学和尿液分析参数方面的差异在毒理学上不被认为具有显著性,因为它们与剂量无关和/或因为数值仍在历史对照范围内。这些结果支持MBE口服的安全性。

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