桑椹颗粒的质量标准研究

Study on the quality standard for Mulberry Granules

目的建立桑椹颗粒(柠檬酸等)的质量控制方法。方法采用薄层鉴别法(TLC)对制剂中的柠檬酸进行定性鉴别;以HPLC法测定桑椹颗粒中柠檬酸的含量:采用Kromasil C18色谱柱(250mm×4.6mm,5μm);使用6mL·L^(-1)磷酸水溶液为流动相进行梯度洗脱;流速为0.5mL·min^(-1);检测波长209nm;柱温为30℃。结果柠檬酸的薄层鉴别具有较好的专属性;柠檬酸的回归方程:Y=1 278 680 X+1 614,r=0.999 9,线性范围为0.103 20~1.720 00mg·mL^(-1);平均回收率为98.23%,RSD值为1.99%。结论所建立的方法可用于该制剂的质量控制。

Objective To establish the quality standard for Mulberry Granules(containing citric acid etc.).Methods Citric acid in the preparation was identified by TLC.A high performance liquid chromatography(HPLC)method was used with Kromasil C18(250mm×4.6mm,5μm)as a column and 6mL·L^(-1) phosphoric acid solution as the mobile phase in a gradient elution mode.The flow rate was 0.5mL·min^(-1),the detection wavelength was 209 nm,and the column temperature was set at 30℃.Results Citric acid could be identified by TLC with good specificity.Citric acid regression equation was Y=1 278 680 X+1 614 and r=0.999 9,in the concentration range of 0.103 20-1.720 00mg·mL^(-1),and the average recovery was 98.23% with RSD 1.99%.Conclusion The established method can be used for the quality control of the preparation.