HPLC法测定参鱼化痰口服液中黄芩苷的含量及急性毒性作用研究

HPLC Determination on Flavonoside Content and Acute Toxicity Studies in Shenyu Huatan Oral Liquid

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。

Objective： To establish a determining method for flavonoside content in the Shenyu Huatan Oral Liquid and observe its acute toxicity, providing a safe basis for its clinical application. Method： HPLC was used to determine its content and define the maximal dose. Results： The flavonoidine content in the range of 0. 312 mu g and 1. 248 mug is with good linear relation （r= 0.9993, n = 6） and the average recovery rate was 99.29% （RSD = 0.46%, n = 6 ）. The maximal dose of the mouse taking the liquids was 1200g/kg, amount to 1200 times than the amount a person takes a day. Conclusion ： HPLC is stable in controlling the drug＇ s quality and the Shenyu Huatan Oral Liquid has a wide safety range in application with no toxicity.