Evaluation of acute and 28-day repeated dose toxicity of Tolypocladium sinense soft capsule in Sprague-Dawley rats.

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Tolypocladium sinense is a new asexual strain isolated from natural Cordyceps sinensis. The mycelium produced by its fermentation culture has similar chemical components and pharmacological effects to C. sinensis. T. sinense soft capsule is primarily prepared from T. sinense mycelium, which is mainly used for the treatment of body damage induced by low-dose ionizing radiation. However, its potential toxicity remains unclear. This study was designed to assess the toxicological characteristics of T. sinense soft capsules through acute and 28-day repeated dose toxicity studies. In the acute toxicity study, no toxic symptoms or mortality were observed in rats following a single oral administration of 10 000 mg/kg of T. sinense soft capsules. The maximum tolerated dose for a single oral dose of T. sinense soft capsules in rats was over 10 000 mg/kg. During the repeated dose toxicity test, oral administration of 90, 360, and 1440 mg/kg/day of T. sinense soft capsules for 28 consecutive days did not lead to significant toxic effects in rats. The no observed adverse effect level in rats surpassed 1440 mg/kg/day. These results provide preliminary evidence that T. sinense soft capsules are relatively safe.