Acute Oral Toxicity Studies of a Chinese Herbal Preparation Shenrong Bunao Capsule

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[Objectives]This study was conducted to evaluate the acute oral toxicity of Shenrong Bunao Capsule,and to provide a theoretical basis for drug development and clinical trials. [Methods]Kunming mice were randomly assigned into two groups: an experimental group and a control group. In experimental group,Shenrong Bunao Capsule solution at maximum concentration of 45% was administered orally by gavage once at a dose of 30 ml/kg body weight( BW),while an equal volume of saline solution was given in the control group. Then,the appearance,behavior,mental state,diet,feces,urine,coat,skin color,respiration,nose,eyes and oral secretions and other daily activities of the mice were observed for 14 d after drug administration. At the end of the experiment,the mice were dissected,and their main organs were examined histopathologically. [Results] The appearance,behavior,respiration,body posture,response to stimuli and weight gain of the mice in control group were all normal. All the mice given 13. 500 g/kg BW Shenrong Bunao Capsule were alive 14 d after drug administration,and their appearance,behavior,respiration,body posture,response to stimuli and weight gains did not show any abnormality. In addition,the body weights of male and female mice had no obvious difference between the experimental group and the control group at the binging,7 and 14 d after drug administration( P < 0. 05).[Conclusions]A maximum dose 13. 500 g/kg BW Shenrong Bunao Capsule,which was equivalent to 141 times of the recommended dosage for adult men was given to the mice,and did not result in any apparent toxic effects,suggesting that the Chines herbal preparation Shenrong Bunao Capsule has very little acute toxicity,and the commonly recommended dosage in clinical trials is safe. [Objectives] This study was undertaking to evaluate the acute oral toxicity of Shenrong Bunao Capsule, and to provide a theoretical basis for drug development and clinical trials. [Methods] Kunming mice were randomly assigned into two groups: an experimental group and a control group In experimental group, Shenrong Bunao Capsule solution at maximum concentration of 45% was administered orally by gavage once at a dose of 30 ml / kg body weight (BW), while an equal volume of saline solution was given in the control group. Then , the appearance, behavior, mental state, diet, feces, urine, coat, skin color, respiration, nose, eyes and oral secretions and other daily activities of the mice were observed for 14 d after drug administration. At the end of the experiment , the mice were dissected, and their main organs were examined histopathologically. [Results] The appearance, behavior, respiration, body posture, response to stimuli and weight gain of the mice in control group were all normal. 0 g / kg BW Shenrong Bunao Capsule were alive 14 d after drug administration, and their appearance, behavior, respiration, body posture, response to stimuli and weight gains did not show any abnormality. In addition, the body weights of male and female mice had no obvious difference between the experimental group and the control group at the binging, 7 and 14 d after drug administration (P <0.05). [Conclusions] A maximum dose 13. 500 g / kg BW Shenrong Bunao Capsule, which was equivalent to 141 times the the recommended dosage for adult men was given to the mice, and did not result in any apparent toxic effects, suggesting that the Chines herbal preparation Shenrong Bunao Capsule has very little acute toxicity, and the commonly recommended dosage in clinical trials is safe.
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