Shi Jian-Ping, Li Shui-Xiu, Ma Zheng-Lai, Gao Ai-Li, Song Yan-Jun, Zhang Hong
Department of Dermatology First Affiliated Hospital and Institute of Mycology, Jinan University, Guangzhou, 510632, China.
Department of Dermatology Shenzhen Shajing Affiliated Hospital of Guangzhou Medical University, Shenzhen, Guangdong Province, 518104, China.
Chin J Integr Med. 2016 Dec;22(12):925-931. doi: 10.1007/s11655-015-2303-2. Epub 2015 Oct 29.
To evaluate the acute and sub-chronic toxicity of intravenously administered tetrandrine (TET) in female BALB/c mice.
The median lethal dose (LD) of intravenously administered TET was calculated in mice using Dixon's up-and-down method. In the acute toxicity study, mice were intravenously administered with TET at a single dose of 20, 100, 180, 260 and 340 mg/kg, respectively and were evaluated at 14 days after administration. In the sub-acute toxicity study, mice were intravenously administered various doses of TET (30, 90 and 150 mg/kg) each day for 14 consecutive days. Clinical symptoms, mortality, body weight, serum biochemistry, organ weight and histopathology were examined at the end of the experiment, as well as after a 1-week recovery period.
LD was found to be 444.67±35.76 mg/kg. In the acute toxicity study, no statistically signifificant differences in body weight, blood biochemistry, or organ histology were observed between the administration and control groups when mice were intravenously administered with single dose at 20, 100, 180, 260 and 340 mg/kg of TET (P >0.05). In the sub-acute toxicity study, no signifificant changes in body weight, biochemistry and organ histology were observed with up to 90 mg/kg of TET compared with the control group (P >0.05), however, in the 150 mg/kg administered group, TET induced transient toxicity to liver, lungs and kidneys, but withdrawal of TET can lead to reversal of the pathological conditions.
The overall fifindings of this study indicate that TET is relatively non-toxic from a single dose of 20, 100, 180, 260 or 340 mg/kg, and that up to 90 mg/kg daily for 14 consecutive days can be considered a safe application dose.
评估静脉注射粉防己碱（TET）对雌性BALB/c小鼠的急性和亚慢性毒性。
采用Dixon上下法计算小鼠静脉注射TET的半数致死剂量（LD）。在急性毒性研究中，小鼠分别以20、100、180、260和340mg/kg的单剂量静脉注射TET，并在给药后14天进行评估。在亚急性毒性研究中，小鼠连续14天每天静脉注射不同剂量的TET（30、90和150mg/kg）。在实验结束时以及1周恢复期后，检查临床症状、死亡率、体重、血清生化指标、器官重量和组织病理学。
LD为444.67±35.76mg/kg。在急性毒性研究中，当小鼠分别以20、100、180、260和340mg/kg的单剂量静脉注射TET时，给药组和对照组在体重、血液生化或器官组织学方面未观察到统计学显著差异（P>0.05）。在亚急性毒性研究中，与对照组相比，高达90mg/kg的TET剂量下，体重、生化指标和器官组织学未观察到显著变化（P>0.05），然而，在150mg/kg给药组中，TET对肝脏、肺和肾脏产生了短暂毒性，但停药后病理状况可逆转。
本研究的总体结果表明，单剂量20、100、180、260或340mg/kg的TET相对无毒，连续14天每天高达90mg/kg的剂量可被视为安全应用剂量。
