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目的建立“参鱼化痰口服液”中黄芩苷含量的测定方法,并观察该制剂的急性毒性,为临床安全用药提供依据。方法采用HPLC测定参鱼化痰口服液中黄芩苷的含量,并测定其最大给药剂量。结果 HPLC测定黄芩苷含量在0.312μg~1.248μg范围内线性关系良好(r=0.9993,n=6),平均回收率为99.29%(RSD=0.46%,n=6);小鼠灌胃参鱼化痰口服液最大耐受量1200 g/kg,相当于人体用药日剂量的1200倍。结论该质量控制方法稳定,小鼠实验用药安全范围较宽,无毒性作用
Objective To establish a method for the determination of baicalin in “Shen Yu Huatan Oral Liquid” and to observe the acute toxicity of the preparation, so as to provide evidence for the clinical use of drugs. Methods The content of baicalin in Shenyou Huatan oral solution was determined by HPLC and the maximum dosage was determined. Results The linearity was good (r = 0.9993, n = 6) and the average recovery was 99.29% (RSD = 0.46%, n = 6) Huatan oral liquid maximum tolerated 1200 g / kg, equivalent to 1200 times the daily dose of human medication. Conclusion The method of quality control is stable, and the experimental drug safety in mice is wide and non-toxic