Chinese Journal of Pharmacovigilance ›› 2014, Vol. 11 ›› Issue (10): 577-579.

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WANG Ying-ting (First People Hospital of Jining, Shandong Jining 272000, China)

  

  • Received:2014-03-31 Revised:2016-02-03 Online:2014-10-08 Published:2016-03-02

Abstract: Objective To study the acute toxicity of the pH-triggered Jie-chang-ning colon-targeted pellets to mice, provide important basic data for further safety evaluation. Methods On the basis of the acute toxicity pre-experiment, the maximum daily dosage test was finished.40mice were randomly divided into drug-treated, control groups. The drug-treated mice were administrated orally with the pH-triggered Jie-chang-ning colon-targeted pellets with intragastric volume40mL·kg-1·d-1. The clinical responses were observed. The mice weight on the1st, 7th, 14th day, was weighed, compared. The viscera index of liver, kidney, spleen was compared on the14th day. Results The mice didn't die in the acute toxicity experiment, but erect hairs, slight tremor body, dull, hunger, frequent defecation, pale retina appeared. The half lethal dosewasn't determined. The viscera index of liver, kidney, spleen wasn't significantly different between the drug-treated, the control groups. The maximum daily dosage was78.496g·kg-1·d-1, which was237.9~314.0times of adult people. Conclusion The maximum daily dosage was more than100times dose of adult people, which explains the pH-triggered Jie-chang-ning colon-targeted pellets is safe within the recommended dosage range. The symptoms in the mice acute toxicity explain that side effects maybe appear for excessive use

Key words: Key words: colon-targeted pellets,
acute toxicity,

mice

CLC Number: