痤疮饮口服液质量标准研究

Study on Quality Standard for Acne Oral Liquid

目的：建立痤疮饮口服液的质量标准。方法：采用薄层色谱法鉴别处方中的丹参、赤芍、甘草和黄芩;采用高效液相色谱法（HPLC）测定金银花中绿原酸含量,色谱柱为Phenomenex Luna C18柱（250 mm×4.60 mm,5μm）;流动相：乙腈-0.2%磷酸水（10∶90）;检测波长：327 nm;流速：1.0 m L/min;柱温：30℃。结果：薄层色谱鉴别方法简单,斑点清晰,专属性强,阴性无干扰。HPLC测定绿原酸进样量在16.4~180.4μg范围内呈良好的线性关系（r=0.9998）,平均回收率为98.24%,RSD为0.88%（n=6）。结论：所建立的方法无干扰、专属性强、重现性好,可较好地控制痤疮饮口服液的质量。

Objective：To establish the quality standard of Acne Oral Liquid. Methods：Salvia miltiorrhiza,Paeonia veitchii,Glycyrrhiza uralensis,Scutellaria baicalensis were identified by TLC qualitatively.The content of Chlorogenic acid was determined by HPLC. The separation was performed on Phenomenex Luna XDB- C18（250 mm×4.60 mm,5 μm）column with mobile phase consisted of Acetonitrile-0.2% phosphoric acid water（10 ∶90,V/V）at the flow rate of 1.0 m L/min. The detection wavelength was set at 327 nm,and the column temperature was 30 ℃. Results：TLC simple,clear spots,specific,negative non-interference. HPLC determination of the injection volumeof Chlorogenic acid in16.4~180.4 μg showed a good linear relationship（r=0.9998）,The average recovery was 98.24%（RSD=0.88%,n=6）. Conclusion：The established standard without interference,specific,reproducible,and can better control the quality of oral acne drink.