清化丸质量标准探讨

目的:进一步完善清化丸的质量标准.方法:采用显微法对处方中玄参、赤芍、连翘进行定性鉴别；采用高效液相色谱法同时测定清化丸中绿原酸及黄芩苷的含量.结果:显微鉴别法专属性强,可鉴定出玄参、赤芍、连翘的显微特征.HPLC法同时测定绿原酸和黄芩苷的含量,绿原酸在0.03296 ～ 0.4944 μg/mL浓度范围内与峰面积积分呈良好的线性关系(r=0.9999),平均回收率为100.6％,RSD=0.12％ (n=5)；黄芩苷在0.04827～0.7240 μg/mL浓度范围内与峰面积积分呈良好的线性关系(r=0.9999),平均回收率为98.6％,RSD=0.82％(n=5).结论:本文所建立的方法可用于完善清化丸的质量控制标准.

Discuss on Quality Standard of Qinghua Pills

Objective: To improve the quality standard of Qinghua Pills.Methods: Red peony root,Forsythia,and Scrophulariaceae were qualitatively identified by using microscopic method.The content of chlorogenic acid and baicalin were determined simultaneously by HPLC.Results: Typical features of Red peony root,Forsythia and Scrophularia were observed by microscope.The linear range of chlorogenic acid was 0.03296~0.4944 μg/mL(r=0.9999) with an average recovery of 100.6% and RSD was 0.12%(n=5).The linear range of baicalin was 0.04827~0.72405 μg/mL(r=0.9999) with an average recovery of 98.6% and RSD was 0.12%(n=5).Conclusions: The standard could be applied to improving the quality control of Qinghua Pills.