咽舒康口服液薄层鉴别及含量测定研究

Identification and determination of Yanshukang oral liquid by thin-layer chromatography

目的:建立咽舒康口服液的质量标准。方法:采用TLC法鉴别处方中黄芩、玄参、青果;采用HPLC法测定处方中的黄芩苷含量。选用依利特Hypersil ODS2(4.6 mm×250 mm,5μm)色谱柱;以0.1%磷酸水溶液-甲醇(53∶47)为流动相;流速为1.0 m L/min,柱温30℃;检测波长280 nm。结果:青果、黄芩、玄参的薄层色谱主斑点清晰,阴性并无干扰,可作为定性鉴别;含量测定中黄芩苷范围在67.32~157.08 ng内与其峰面积呈现良好线性关系,回归方程为A=0.0576C+0.0816(R^2=0.99997),平均回收率为102.12%(RSD=1.06%,n=6)。结论:该方法结果可靠,分离效果及专属性良好,可用来对本制剂进行质量控制。

Objective:To establish the quality standard for Yanshukang oral liquid.Methods:Thin-layer chromatography(TLC)was used to initially identify the test sample of Yangshukang oral liquid containing Scutellaria baicalensis,Figwort root and Chinese olive.Then high performance liquid chromatography(HPLC)was performed to determine the baicalin concentration.Isolation and measurement of the component was conducted on Hypersil ODS C18 column(4.6 mm×250 mm,5μm)by mobile phase consisting of methanol-0.1%phos-phoric acid solution(53:47),detective wavelength at 280 nm and the column temperature being at 30℃.Results:Scutellaria baicalensis,Figwort root and Chinese olive were clearly spotted on TLC without interference.Baicalin content was ranged from 67.32 to157.08 ng,and had a good linear relation with the peak area(R 2=0.999 97).Regression equation was A=0.0576C+0.0816,and average recovery rate for baicalin was 102.12%(RSD=1.06%,n=6).Conclusion:Our protocol can be reliable,specific and reproducible for quality control of this preparation.