辛兰芷喷雾剂质量标准研究

Quality Standard for Xinlanzhi Spray

目的：建立辛兰芷喷雾剂的质量标准。方法：采用TLC法对方中辛夷、板蓝根、白芷进行定性分析；用HPLC法对连翘苷进行含量测定。结果：TLC法可准确地对辛夷、板蓝根、白芷进行定性鉴别；连翘苷进样量在0．2～10．0μg范围内与峰面积积分值呈良好线性关系（r=0．9997）；平均回收率为99．71％，RSD=1．85％（n=6）。结论：本方法简便、快速、重现性好，所建标准可用于本制剂的质量控制。

OBJECTIVE： To establish quality standard for Xinlanzhi Spray. METHODS： The qualitative analysis for Flos Magnoliae, Radix Isatidis and Radix Angelicae Dahuricae was performed using TLC, and the content of Forsythin in the Xinlanzhi spray was determined by HPLC. RESULTS： Flos Magnoliae, Radix Isatidis and Radix Angelicae Dahuricae could be accurately identified by TLC. There was good linearity for Forsythin within the range of 0.2-10.0μg（r = 0.999 7）, and its average recovery was 99.71% with RSD at 1.85% （n = 6）. CONCLUSION：The method is simple,rapid and reproducible,and it can be used for the quality control of Xinlanzhi spray.