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

Wan, Li; Jiang, Hanjie; Ablat, Nuramatjan; Wang, Chen; Guo, Yongfei; Sun, Yi; Zhao, Xin; Xu, Jiamin; Zhang, Ke; Ren, Rutong; Pu, Xiaoping

doi:10.1016/j.jep.2016.05.050

Cited by 15 publications

(11 citation statements)

References 26 publications

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“…The blood routine parameters of laboratory animals were less affected by environment and other conditions [45]. Previous research has reported that male rats had a significant higher level of MCHC compared to female rats of the same age [46], and our present study also found the same results. However, with additional statistical analysis, it was found that the MCHC change observed had no clinical significance.…”

Section: Discussionsupporting

confidence: 87%

Safety Evaluation of a New Traditional Chinese Medical Formula, Ciji-Hua’ai-Baosheng II Formula, in Adult Rodent Models

Zhai

et al. 2019

Evidence-Based Complementary and Alternative Medicine

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Background Ciji-Hua'ai-Baosheng II Formula (CHB-II-F) is a new traditional Chinese medical formula that has been shown to reduce toxicity and side effects of chemotherapy and increase the probability of cancer patient survival. Whether CHB-II-F is safe as an adjunctive therapy for cancer patients receiving chemotherapy has yet to be determined. Purpose To evaluate the acute and subchronic toxic effects of CHB-II-F in rodent models. Methods In acute toxicity test, 24 Kunming mice were divided into 2 groups: untreated control and CHB-II-F 1.05 g/mL (31.44 g/kg) treated group. Treatment was administered to the treated group 3 times a day for 14 days. The overall health, adverse reactions, and mortality rate were documented. In subchronic toxicity test, 96 Sprague-Dawley rats were divided into 4 groups: untreated control, high dose CHB-II-F (H) (26.20 g/kg), medium dose CHB-II-F (M) (13. 10 g/kg), and low dose CHB-II-F (L) (6.55 g/kg) [equal to 24.375 g (dried medicinal herb)/kg] treated groups. Treated groups were given the treatments once a day for 4 weeks. The overall health and mortality rate were recorded every day. Body weight and food consumption were measured once a week. Hematologic and biochemical parameters, organ weights, and histopathologic markers were analyzed after 4 weeks. An additional 2 weeks were given as the treatment recovery period before end-point euthanization, and biochemical analyses were performed. Results The maximum tolerated dose (MTD) of CHB-II-F on mice was found to be 94.31 g/kg [equal to 351 g (dried medicinal herb)/kg], which is 108 times the human adult dose. In the acute toxicity test, administration of CHB-II-F 31.44 g/kg showed no adverse effect and did not cause mortality. In the subchronic toxicity test, after 4 weeks of treatment, compared to the controls, total cholesterol (TCHO) level, cardiac and splenic indexes, body weights of female rats, and mean corpuscular hemoglobin concentration (MCHC) in the CHB-II-F (H) group were significantly increased; triglyceride (TG) in the CHB-II-F (M) group and liver and splenic indexes in the CHB-II-F (L) group were increased. After the two-week recovery period, biofluid analyses, food consumption, and histopathologic examinations showed no abnormalities. Conclusion Administration of CHB-II-F had no obvious adverse effect on the overall health of rodent models. A daily maximum dose of less than 94.31 g/kg or 6.55 g/kg CHB-II-F for 4 continuous weeks was considered safe.

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Section: Discussionsupporting

confidence: 87%

Safety Evaluation of a New Traditional Chinese Medical Formula, Ciji-Hua’ai-Baosheng II Formula, in Adult Rodent Models

Zhai

et al. 2019

Evidence-Based Complementary and Alternative Medicine

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“…Moreover, at the end of the experiment, all tested hematological and serum biochemical parameters were within the normal range, and no significant differences were observed, which were considered as the sensitive indicators of the toxicity of drugs and chemicals, they also give an important index for physiological and pathological status in humans and animals in general ( Olson et al, 2000 ). Meanwhile, because the liver and kidney are sensitive organs, and their functions are known to be affected by a number of factors, such as drugs, ultimately leading to renal failure and liver toxicity ( Li et al, 2016 ), and stomach and small intestine are main responsible for digesting the food or drugs administrated to mice. In our assay, the histopathological changes of liver, spleen, kidney, stomach, and small intestine of mice in three DHP-treated groups and control group also were investigated, respectively.…”

Section: Discussionmentioning

confidence: 99%

The Anti-diarrheal Activity of the Non-toxic Dihuang Powder in Mice

Shang¹,

Miao²,

Yang³

et al. 2018

Front. Pharmacol.

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Dihuang powder (DHP) has been used in the traditional Chinese medicine for the treatment of diarrhea in some regions of China. But up to now, the anti-diarrheal activity of DHP haven’t been performed with modern pharmacological technology. This study aims to investigate the quality control, the potential toxicity and anti-diarrheal activity of Dihuang powder in mice. High performance liquid chromatography (HPLC) and thin layer chromatography (TLC) were used to detect five active compounds in DHP for quality control, and the acute toxicity and sub-acute toxicity for 28-day oral administration of DHP were then evaluated. The anti-diarrheal activity was investigated using mouse model. Results showed that the levels of quercetin and berberine in DHP were 0.054 and 0.632 mg/g, respectively, and atractylodin, matrine, and patehouli aleohal were also detected in DHP. At the given doses, DHP was safe in terms of acute and sub-acute toxicity. Meanwhile, DHP exhibited strong anti-diarrheal effects as well as decreased gastrointestinal motility and the secretions induced by Sennae and castor oil in a dose-dependent manner. It could decrease the content of IL-1β, IL-6, and TNF-α in the small intestine, and improve the histopathological changes of small intestine and large intestine induced by Sennae. The antinociceptive and anti-inflammatory activities in vivo also were presented. Based on all of the results, we thought that DHP has anti-diarrheal activity, and could be used to treat diarrhea as well as alleviate the pain and inflammation induced by diarrhea. This study provides a theoretical basis for the clinical use of DHP and may assist in the development of new drugs for the treatment of diarrhea. The mechanism of the anti-diarrheal activity should be investigated in the future.

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“…In contrast, the ROW of the liver decreased significantly (P < 0.05, P < 0.01), and the female rats showed more obvious changes than the male rats. Considering the OW and ROW are important indicators to diagnose whether an organ suffers treatment-related injury [29][30][31] , the reason might be due to the increasing dose and time of drug administration, the toxic damage caused by UEDR gradually increased, and the body weights of rats in the high-dose group increased slowly, which would result in weight loss. Furthermore, no significant differences were observed on the ROWs between the treated www.nature.com/scientificreports/ and control groups after 14 days withdrawal (P > 0.05).…”

Section: Discussionmentioning

confidence: 99%

Toxicological evaluation of the ultrasonic extract from Dichroae radix in mice and wistar rats

Wang¹,

Guo²,

Cui³

et al. 2020

Sci Rep

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This study was aimed at evaluating the acute and subchronic toxicity of ultrasonic extract of Dichroae radix (UEDR) in mice and rats. High performance liquid chromatography (HPLC) and thin layer chromatogrephy (TLC) were used to detect β-dichroine and α-dichroine in UEDR for quality control. The levels of β-dichroine and α-dichroine in UEDR were 1.46 and 1.53 mg/g, respectively. An oral LD50 of 2.43 g/kg BW was observed in acute toxicity test. After 28-day repeated oral administration, compared with the control group, treatment-related changes in body weight (BW) and body weight gain (BWG), lymphocyte counts and ratios, as well as in the relative organ weights (ROWs) of liver, kidney, lung, and heart, were detected in the middle- and high-dose groups (P < 0.05, P < 0.01), no differences were noted in the serum biochemical parameters and necropsy examinations in both sexes at all doses. Histopathological examinations exhibited UEDR-associated signs of toxicity or abnormalities. After 14 days withdrawal, no statistically significant or toxicologically relevant differences were observed in any of the UEDR-treated groups, and the hispathological lesions in the high-dose group were alleviated. Findings showed that long-course and high-dose of UEDR administration was toxic, and showed dose-dependence, the toxic damage was reversible.

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

Cited by 15 publications

References 26 publications

Safety Evaluation of a New Traditional Chinese Medical Formula, Ciji-Hua’ai-Baosheng II Formula, in Adult Rodent Models

Safety Evaluation of a New Traditional Chinese Medical Formula, Ciji-Hua’ai-Baosheng II Formula, in Adult Rodent Models

The Anti-diarrheal Activity of the Non-toxic Dihuang Powder in Mice

Toxicological evaluation of the ultrasonic extract from Dichroae radix in mice and wistar rats

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