板翘口服液质量标准的研究

Quality Standard for Banqiao Oral Liquid

目的建立板翘口服液的质量标准。方法采用薄层色谱法(TLC)对制剂中板蓝根、连翘和知母进行薄层鉴别;采用高效液相色谱法(HPLC)测定连翘苷的含量。结果在TLC图谱中可检出板篮根、连翘和知母的特征斑点。连翘苷在10～90μg/ml的浓度范围内线性关系良好,Y=12 278.16X-33.2(r=0.999 9),平均回收率为99.7%,RSD为2.5%(n=5)。结论该方法简便、准确、专属性强,可用于该制剂的质量控制。

Objective To establish the standard of Banqiao oral liquid.Methods Radix Isatidis,Fructus Forsythiae and Rhizoma Anemarrhenae sinensis were identified by TLC.The content of forsythin was determined by HPLC.Results Radix Isatidis,Fructus Forsythiae and Rhizoma Anemarrhenae sinensis could be identified by TLC.It showed a good linear relationship at the range of 10～90 μg /ml（r=0.999 9） for forsythin determination.The average recovery was 99.7%,with RSD of 2.5%（n=5）.Conclusion The method is simple,reliable,accurate,and can be applied to the quality controlof the preparation.