Park Eunsook, Lee Mee-Young, Seo Chang-Seob, Yoo Sae-Rom, Jeon Woo-Young, Shin Hyeun-Kyoo
K-herb Research Center, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea.
BMC Complement Altern Med. 2016 Sep 22;16(1):370. doi: 10.1186/s12906-016-1342-3.
Melandrii Herba, a medicinal plant, has been used in Korea for treatment of bacterial and fungal infection. However, the safety and toxicity of Melandrii Herba have not yet been established. Therefore, we investigated the acute and subacute toxicity of an ethanolic extract of Melandrii Herba (MHEE) in Crl:CD Sprague Dawley rats and cytotoxicity of MHEE in vitro.
To study acute toxicity, rats were treated with MHEE at single doses of 0, 500, 1000, and 2000 mg/kg administered by oral gavage, and body weight, clinical signs, and mortality were observed after dosing. To study subacute toxicity, rats were treated with MHEE at doses of 0, 500, 1000, and 2000 mg/kg administered once a day by gavage for 4 weeks. We measured clinical signs, mortality, gross pathological findings, body and organ weights, food consumption, serum biochemistry, and conducted hematology and urinalysis. The cytotoxicity of MHEE was assayed by measuring the viability of prostate cell lines including normal prostate stromal WPMY-1, normal prostate epithelial RWPE-1, and benign prostatic hyperplasia epithelial BPH-1 cells at various concentrations of MHEE in vitro.
Single oral doses of MHEE caused no significant difference in rat clinical signs, mortality, or body weight. The lethal dose of MHEE was considered to be >2000 mg/kg. Daily oral doses of MHEE for 4 weeks did not result in any significant changes in rat mortality, gross pathological findings, relative organ weights, food consumption, hematology, serum biochemistry, or urinalysis. At MHEE >1000 mg/kg/day, salivation was increased in both male and female rats. However, the salivation caused by the MHEE treatment was not accompanied by pathological changes in body weight or gross pathological findings, and we considered the salivation as a minor symptom. Therefore, no adverse effects were seen at 2000 mg/kg/day or less. MHEE showed no cytotoxic effects on either normal prostate or benign prostatic hyperplasia cell lines.
Administration of MHEE in Crl:CD Spradgue Dawley rats is nontoxic and is safe for at least a month.
白屈菜作为一种药用植物，在韩国已被用于治疗细菌和真菌感染。然而，白屈菜的安全性和毒性尚未确定。因此，我们研究了白屈菜乙醇提取物（MHEE）对Crl:CD斯普拉格-道利大鼠的急性和亚急性毒性以及MHEE在体外的细胞毒性。
为研究急性毒性，给大鼠经口灌胃给予单剂量0、500、1000和2000mg/kg的MHEE，给药后观察体重、临床体征和死亡率。为研究亚急性毒性，给大鼠经口灌胃给予剂量为0、500、1000和2000mg/kg的MHEE，每天1次，持续4周。我们测量了临床体征、死亡率、大体病理结果、体重和器官重量、食物消耗量、血清生化指标，并进行了血液学和尿液分析。通过在体外不同浓度的MHEE下测量前列腺细胞系（包括正常前列腺基质WPMY-1、正常前列腺上皮RWPE-1和良性前列腺增生上皮BPH-1细胞）的活力来测定MHEE的细胞毒性。
单次经口给予MHEE对大鼠的临床体征、死亡率或体重没有显著差异。MHEE的致死剂量被认为>2000mg/kg。连续4周每天经口给予MHEE不会导致大鼠死亡率、大体病理结果、相对器官重量、食物消耗量、血液学、血清生化指标或尿液分析有任何显著变化。当MHEE>1000mg/kg/天时，雄性和雌性大鼠的唾液分泌均增加。然而，MHEE处理引起的唾液分泌并未伴有体重或大体病理结果的病理变化，我们认为唾液分泌是一个轻微症状。因此，在2000mg/kg/天及以下未观察到不良反应。MHEE对正常前列腺或良性前列腺增生细胞系均无细胞毒性作用。
在Crl:CD斯普拉格-道利大鼠中给予MHEE无毒，至少在一个月内是安全的。
