七清败毒散质量标准研究

Study on Quality Standard of Qiqing Baidu Powder

根据《中华人民共和国兽药典》(二部)中药材标准,对内蒙古润龙生物科技有限公司研发的七清败毒散进行质量标准研究,旨在为七清败毒散的生产提供质量控制依据。采用紫外分光光度法测定七清败毒散中主药金银花的主要成分绿原酸的含量,用薄层色谱法对处方中的主药板蓝根进行鉴别。结果显示,绿原酸在13.2μg/mL~66.0μg/mL范围内具有良好的线性关系,标准曲线回归方程为:A=0.0373×C-0.0099(r=0.9999,n=6);七清败毒散的绿原酸含量为1.763μg/mg。绿原酸的加样平均回收率为98.77%,回收率范围在70%~110%之间,日内和日间平均精密度分别为0.356%,0.096%,均小于5%。结果显示,紫外分光光度法可以用于处方中金银花的定量测定,方法可靠,无需校正;薄层鉴别法专属性强,可以用于处方中板蓝根的定性鉴别。

According to the standard of“Veterinary Pharmacopoeia of the Peoples Republic of China”(PartⅡ),the quality standard of Qiqing Baidu Powder was studied,which provided by Inner Mongolia Runlong Biotechnology Co.Ltd,to provide the basis for Qiqing Baidu Powder production.The content of chlorogenic acid,the main component of Lonicera japonica in Qiqing Baidu Powder,was determined by UV-visible spectrophotometry.TLC(thin layer chromatography)was used to identify radix isatidis in the prescription.The results showed that chlorogenic acid had a good linear relationship in the range of 13.2-66.0μg/mL.The regression equation of the standard curve was as follows:A=0.0373×C-0.0099(r=0.9999,n=6).The content of chlorogenic acid in Qiqing Baidu Powder is 1.763μg/mg.The average recovery of chlorogenic acid was 98.77%.The recovery range was 70%-110%.RSDs of within-day and between-day were 0.356%and 0.096%respectively,less than 5%.The results showed that UV-visible spectrophotometry can be used for the quantitative determination of Lonicera japonica in prescriptions,and the method is reliable without correction;the TLC identification method has strong specificity and can be used for qualitative identification of radix isatidis in prescriptions.