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采用标准的体外和体内检测方法评估芦根提取物的遗传毒性。

Genotoxicity evaluation of a Phragmitis rhizoma extract using a standard battery of in vitro and in vivo assays.

机构信息

Clinical Medicine Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea.

Nonclinical Research Institute, Chemon Inc., 240 Nampyeong-ro, Yangji-myeon, Cheoin-gu, Yongin, 17162, Republic of Korea.

出版信息

J Ethnopharmacol. 2019 Sep 15;241:112025. doi: 10.1016/j.jep.2019.112025. Epub 2019 Jun 9.

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE

A rhizome of Phragmites communis Trinius has been used in traditional medicine to remove a heat, relieve vomiting and fever, nourish body fluids, and treat diseases like cancers. However, the safety of Phragmitis rhizoma has not yet been fully assessed.

AIM OF THE STUDY

The present study evaluated the genotoxicity of an aqueous extract of Phragmitis rhizoma (AEPR).

MATERIALS AND METHODS

The genotoxic potential of AEPR was evaluated using both in vitro and in vivo assay systems: a bacterial reverse mutation (AMES) test using auxotrophic mutant strains of Salmonella typhimurium (TA100, TA1535, TA98, TA1537) and Escherichia coli (WP2 uvrA), a chromosomal aberration test using Chinese hamster lung cells, and a micronucleus test using bone marrow cells from male ICR mice subjected to an oral administration of AEPR. All tests were completed in compliance with the OECD guidelines or regional regulatory standards for toxicity study, and Good Laboratory Practice.

RESULTS

When compared with the negative control, no genotoxic signs related to the AEPR treatment were observed in the AMES test up to 5000 μg/plate of AEPR and in the chromosomal aberration test up to 500 μg/ml of AEPR regardless of metabolic activation. Repeated oral administration of AEPR up to 5000 mg/kg/day for 2 days did not affect the body weight gains or mortalities of the experimental mice and did not induce any significant changes in the frequency of micronucleated polychromatic erythrocytes.

CONCLUSIONS

The present study demonstrated that aqueous extract of Phragmitis rhizoma is safe regarding genotoxicity in an experimental model at least under the conditions tested. Further toxicity assessment in a human clinical study should be done to support the safe use of Phragmitis rhizoma by patients and healthcare providers.

摘要

植物亲缘学相关性

香蒲根茎在传统医学中被用于退热、止呕和退烧、滋阴以及治疗癌症等疾病。然而,香蒲根茎的安全性尚未得到充分评估。

研究目的

本研究评估了香蒲根茎水提物(AEPR)的遗传毒性。

材料和方法

采用体外和体内试验系统评估 AEPR 的遗传毒性:使用营养缺陷型鼠伤寒沙门氏菌(TA100、TA1535、TA98、TA1537)和大肠杆菌(WP2 uvrA)的细菌回复突变(AMES)试验,中国仓鼠肺细胞的染色体畸变试验,以及雄性 ICR 小鼠骨髓细胞的微核试验,经口给予 AEPR。所有试验均符合 OECD 毒性研究指南或区域监管标准以及良好实验室规范进行。

结果

与阴性对照相比,在 AMES 试验中,当 AEPR 处理量高达 5000μg/平板时,或在染色体畸变试验中,当 AEPR 处理量高达 500μg/ml 时,均未观察到与 AEPR 处理相关的遗传毒性迹象,无论是否进行代谢活化。重复给予 AEPR 高达 5000mg/kg/天,连续 2 天,对实验小鼠的体重增加或死亡率没有影响,也没有引起微核多染红细胞频率的任何显著变化。

结论

本研究表明,在实验模型中,香蒲根茎水提物在遗传毒性方面是安全的,至少在测试条件下是如此。在人类临床研究中进行进一步的毒性评估,以支持患者和医疗保健提供者安全使用香蒲根茎。

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