To observe the toxicity and extent of long-term oral Kangxuan granules in rats to determine the safety of clinical drug use. Kangxuan granules were treated with 25g kg−1 d −1 for 12 weeks. The changes of physiologic and biochemical indexes such as appearance, body mass, liver and kidney function, blood glucose metabolism were observed. There was no obvious change in appearance and body mass, and the viscera specific mass and pathological examination were normal. Kangxuan granules in clinical dosage of 50 times the case, rats are safe and non-toxic.

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