Evaluation of the acute and sub-chronic oral toxicity of the herbal formula Xiaoer Chaigui Tuire Oral Liquid

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• 作者：Wan li^a ; ^b ; ^{liwan19881105@163.com" class="auth_mail" title="E-mail the corresponding author} ; Hanjie Jiang^a ; ^b ; ^{jhanjie@126.com" class="auth_mail" title="E-mail the corresponding author} ; Nuramatjan Ablat^a ; ^b ; ^{370012531@qq.com" class="auth_mail" title="E-mail the corresponding author} ; Chen Wang^a ; ^b ; ^{wangchen0702@163.com" class="auth_mail" title="E-mail the corresponding author} ; Yongfei Guo^a ; ^b ; ^{guoyongfei08@126.com" class="auth_mail" title="E-mail the corresponding author} ; Yi Sun^a ; ^b ; ^{sunyi@bjmu.edu.cn" class="auth_mail" title="E-mail the corresponding author} ; Xin Zhao^a ; ^b ; ^{zhaoxin2010@bjmu.edu.cn" class="auth_mail" title="E-mail the corresponding author} ; Jiamin Xu^a ; ^b ; ^{zeroby@126.com" class="auth_mail" title="E-mail the corresponding author} ; Ke Zhang^a ; ^b ; ^{1450140768@qq.com" class="auth_mail" title="E-mail the corresponding author} ; Rutong Ren^a ; ^b ; ^{rrt874609@163.com" class="auth_mail" title="E-mail the corresponding author} ; Xiaoping Pu^a ; ^b ; ^{puxiaopingbj@163.com" class="auth_mail" title="E-mail the corresponding author}
• 关键词：XCTOL ; Xiaoer Chaigui Tuire Oral Liquid ; ROW ; relative organ weight ; MTD ; maximum-tolerated doses ; WBC ; white blood cell ; LYMPH ; lymphocyte ; MONO ; monocyte ; NEUT ; neutrophile granulocyte ; EOS ; eosinophils ; BASO ; basophilic cell ; RBC ; red blood cell count ; HGB ; hemoglobin concentration ; HCT ; hematocrit ; MCV ; mean corpuscular volume ; MCH ; mean corpuscular hemoglobin ; MCHC ; MCH concentration ; RDW ; red blood cell distribution width ; RDW-CV ; red blood cell distribution width coefficient of variabilit
• 刊名：Journal of Ethnopharmacology
• 出版年：2016
• 出版时间：2 August 2016
• 年：2016
• 卷：189
• 期：Complete
• 页码：290-299
• 全文大小：3031 K

文摘

Xiaoer Chaigui Tuire Oral Liquid (XCTOL) is a popular Chinese herbal formula. It is used to treat exogenous fever in children by inducing diaphoresis and clearing interior heat.

Aim of the study

To evaluate the acute and sub-chronic toxicity of XCTOL in mice and rats, respectively.

Materials and methods

In the acute toxicity study, mice were orally administered 100 g/kg body weight XCTOL three times a day. General behavior, adverse effects and mortality were recorded for 14 days after treatment. In the sub-chronic toxicity study, rats were orally administered 0, 20 or 80 g/kg XCTOL for 30 days. The rats were observed daily for clinical signs and mortality. Body weight changes were measured every three days, and relative organ weights, hematological parameters, urinalysis results, biochemical parameters and pathology were monitored at the end of treatment. After treatment, a 30-day withdrawal study was conducted.

Results

In the acute toxicity study, after the mice were administered with 300 g/kg (3×100 g/kg) XCTOL in the first day, no adverse effects or death were observed in the following 14 days. In the 30-day sub-chronic toxicity study, daily oral administration of 80 g/kg XCTOL resulted in significant body weight loss in both male and female rats. In the male rats, the red blood cell distribution width standard deviation (RDW-SD) and red blood cell distribution width coefficient of variability (RDW-CV) in the hematological test and total bilirubin (T-Bil) in the blood biochemistry test were significantly increased (RDW-SD, p<0.01; RDW-CV and T-Bil, p<0.05 vs. the control group). In the female rats, the specific gravity of the urinalysis was significantly increased (p<0.05 vs. the control group). Pathological damage was not observed in the main organs in the 80 g/kg group. In the 20 g/kg group, the lymphocyte % (LYM%) was significantly increased (p<0.05 the control group) in the female rats.

Conclusions

The maximum-tolerated dose of XCTOL was greater than 300 g/kg in mice. The no-observed-adverse-effect-level was between 20 and 80 g/kg body weight for 30 days in rats, which is 2.2–8.8 times higher, respectively, than the dose that has already been used in the clinical practice. Therefore, XCTOL at a dose less than 300 g/kg in one day or 20 g/kg per day for 30 days is considered safe.