开胃饮泡腾片的质量标准研究

Study on Quality Standard of Kaiweiyin Effervescent Tablet

目的建立以山楂为主要原料的开胃饮泡腾片的质量控制方法。方法应用酸碱滴定法控制有机酸含量,同时以山楂对照药材和熊果酸作为对照品,分别建立了薄层色谱鉴别和高效液相色谱法控制产品的质量。采用甲苯-乙酸乙酯-甲酸(20∶4∶0.5)为展开剂,硫酸乙醇溶液(3→10)为显色剂进行薄层色谱鉴别;高效液相色谱法采用Waters Symmetry C18柱(250 mm×4.6 mm,5μm),以乙腈-甲醇-水-乙酸铵(75∶15∶10∶0.5)为流动相,检测波长为220 nm。结果薄层色谱鉴别图谱斑点清晰;熊果酸在质量浓度0.05～0.6 g/L范围内与峰面积呈良好线性关系(r=0.999 9),回归方程为Y=2 241 X+236.5,平均回收率为100.78%,RSD为1.6%。结论该质量控制方法简单快速、专属性好、准确度高、重复性好,可用于开胃饮泡腾片的质量控制。

Objective To establish a quality control method for Kaiweiyin Effervescent Tablet with Crataegi fructus as the main raw material.Methods The acid-base titration method was applied for controlling the content of total organic acid,at the same time,with Fructus Crataegi as the contrast medicinal material and ursolic acid as the reference substance,the TLC chromatographic identification and HPLC method for controlling the product quality were established respectively.Methylbenzene-ethyl acetate-formic acid（20 ∶4 ∶0.5）as the developer and sulfuric acid ethanol solution（3→10）as the color reagent were adopted for conducting the TLC chromatographic identification.The HPLC method adopted the Waters Symmetry C18 column（250 mm×4.6 mm,5 μm）with acetonitrile-methanol-water-ammonium acetate（75 ∶15 ∶10 ∶0.5）as the mobile phase and the detection wavelength at 220 nm.Results The spots of the TLC spectrum identification were clear.The mass concentration of ursolic acid during the range of 0.05-0.6 mg/mL showed the good linear relation with the peak area,its regression equation was Y=2 241X＋236.5（r=0.999 9）.The average recovery rate was 100.78%,RSD=1.6%.Conclusion This quality control method is simple and fast with good specificity,high accuracy and good repeatability,and can be used for controlling the quality of Kaiweiyin Effervescent Tablet.