Study on adverse reaction of Xiaoer Xiaoji Zhike Oral liquid on juvenile mice under a long-term clinical dosage
Objective Based on the administration of Xiaoer Xiaoji Zhike Oral Liquid under four clinical procedures(20 d),to investigate its potential toxicity and target organs of toxicity in juvenile mice.Further to anticipate the clinical risks of Arecae Semen and arecoline in children.Methods According to the instructions and available studies,juvenile mice were ig given Xiaoer Xiaoji Zhike Oral Liquid(4.29,17.16 g·kg-1),Bing Lang Jin Gao(0.24,0.96 g·kg-1),and arecoline(0.49,5.46 mg·kg-1)for 20 d.The body weight of mice,serum levels of alanine aminotransferase(ALT),aspartate aminotransferase(AST),lactate dehydrogenase(LDH),urea nitrogen(BUN),creatinine(Cr)were observed.Histopathology of the liver,kidney,heart,and spleen detected by HE staining.Finally,cardiomyocyte apoptosis proteins were detected by immunohistochemistry.Results The body weight of mice was not significantly affected after the administration of Xiaoer Xiaoji Zhike Oral Liquid,Bing Lang Jin Gao and arecoline.There were no remarkable differences in blood biochemical indices related to liver and kidney function compared to the control group.No obvious histopathological changes were observed in organs such as liver,kidney,heart and spleen.Bcl-2-related X protein(Bax),caspase-8,and gasdermin D(GSDMD)were not significantly altered.Conclusion Within the clinical dosage range and after a four-fold administration course,neither of Xiaoer Xiaoji Zhike Oral Liquid,and it contained arecae semen and arecoline have posed toxic side effects in juvenile mice,demonstrating that the risk of the clinical application of Xiaoer Xiaoji Zhike Oral Liquid is controlled.
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