WangShiBaoChiWan (WSBCW) is a traditional Chinese medicine with a recorded administration history of more than 180 years. In the present study, the preclinical safety of WSBCW was evaluated the preclinical safety of WSBCW using a toxicity test, which consisted of an administration period of 28 d and a recovery period of 15 d. During the test, male and female SD rats were administered the medicine once a day by oral gavage, at a dose of 60 mg/kg/day, 600 mg/kg/day, or 1500 mg/kg/day. As a reference medicine, mosapride citrate was administered at a dose of 37.5 mg/kg/day, which was clinically equivalent to the high-dosage treatment of WSBCW. With all the dosage groups, statistically, no adverse effect was observed in terms of clinical observation, food intake, body weights, organ coefficient, blood biochemistry, and histopathology examination. No intestinal melanosis was observed in the rats. When the data were examined animal by animal, test substance-related adverse effects were found with the high-dosage rats in hematology assay. The deranged, however, reversible changes suggested a compromised intestinal barrier, which was also observed with in mosapride citrate-treated rats. In addition to the histopathology assay, molecular toxicology was explored using high-throughput gene sequencing. No evident toxicity was revealed. In summary, administration of WSBCW was well tolerated within a treatment of 28 d.
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