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| Experimental study on acute toxicity and rectal mucosal stimulation of compound sophorae enema |
| Hits 1247 Download times 883 Received:May 31, 2020 |
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| DOI
10.11656/j.issn.1673-9043.2020.05.18 |
| Key Words
compound sophorae enema;mouse;acute toxicity;rat;rectal mucosal irritation |
| Author Name | Affiliation | E-mail | | ZHU Feng | Department of Integrated Chinese and Western Medicine, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China | | | CHU Si | Department of Integrated Chinese and Western Medicine, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China | | | WU Hui | Department of Integrated Chinese and Western Medicine, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China | | | LIU Yujin | Department of Integrated Chinese and Western Medicine, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China | | | FAN Heng | Department of Integrated Chinese and Western Medicine, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China | fanheng009@aliyun.com |
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| Abstract
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| [Objective] To provide a reference for clinically safe medication through experimental research on the acute toxicity and rectal mucosal irritation of compound Sophorae enema.[Methods] Apply the compound sophorae enema with maximum concentration (0.7 g/mL) and volume (0.4 mL/10 g) available for enema,repeated administration twice within 24 h. Observing and recording the spirit,activity status,hair color,diet,excrement,weight change,toxic reactions and deaths of mice within 14 days after administration. The heart,liver,spleen,lung,kidney and colon were dissected and pathologically examined 14 days later. Rectal mucosal stimulation experiments were performed on SD rats for multiple rectal administrations. The dose of the rats was the clinical enema dose,which was continuously administered and observed for 7 days. One rat was dissected 24 h after the first administration,and the rectal mucosal congestion and edema were observed with the naked eyes. The point evaluation method is used to determine whether the drug is irritating to the rectal mucosa,and pathological examination is performed. Five rats were dissected 24 hours after the last administration,and the treatment was the same as before. The remaining rats were discontinued for one week. If there were abnormal results in this pathological examination,the discontinued animals should be subjected to histopathological examination;otherwise,only the anatomy and visual observation were needed.[Results] Acute toxicity test:there was no statistically significant difference in the weight gain trend between the experimental group and the control group (P>0.05). Burnout and laziness appeared within 30 minutes after administration in the experimental group and the normal control group,and normal activities and diet resumed after 2 h. All observation indicators such as appearance,behavior,diet,and excreta were normal within 14 days. No dead mice. No visceral abnormal changes were observed in all viscera of all mice at necropsy. Rectal mucosal stimulation experiment:The body weight of the experimental group and the control group increased in different degrees without significant differences (P>0.05). The rectal mucosal congestion and edema caused by the drug were not seen in the animal anatomy. The integral evaluation method judged that the drug was not irritating to the rectal mucosa. The two histopathological examinations did not show obvious pathological changes. There were no macroscopic pathological changes in the anatomy of the rats after drug withdrawal,and no dead rats.[Conclusion] Under the experimental conditions,the maximum dose of mice enema is 56 g crude drug/kg,which is equivalent to 14.6 times the daily dosage of humans. Experiments show that the clinical enema dose is safe. Compound sophorae enema was administered rectally to rats several times without irritating effect on rectal mucosa. |
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