增光片质量标准的改进

Improvement of Quality Standard for Zengguang Tablets

目的:提高完善增光片的质量标准。方法:修订了原标准的显微鉴别法;采用TLC法对石菖蒲、枸杞子、远志进行鉴别;采用HPLC法测定五味子醇甲的含量,色谱柱为Hypersil BDS C_(18)(250 mm×4.6 mm,5μm),流动相为甲醇-水(1∶1),流速为1.0 ml·min^(-1),检测波长为250 nm,柱温为35℃,进样量为10μl。结果:显微鉴别法专属性强;TLC色谱斑点清晰,专属性强,重复性良好。五味子醇甲对照品在21.17~423.40 ng范围内线性关系良好(r=0.999 9),平均回收率为99.7%,RSD为1.4%(n=6)。结论:所建立的增光片质量标准全面、完善,能有效控制该品种的质量。

Objective： To improve the quality standard for Zengguang tablets. Methods： Instead of the microscopic identification, Acorus tatarinowii rhizoma, Lycii Fructus and Polygalae radix were indentified by TLC. The content of schisandrin in Schisandrae Chinensis Fructus was determined by HPLC. The HPLC system consisted of a Hypersil BDS C18（250 mm ×4.6 mm,5 μm）column, methanol-water （ 1 ： 1 ） was used as the mobile phase at a flow rate of 1.0 ml·min^-1, and the detection wavelength was at 250 nm. The column temperature was 35℃ and the sample size was 10 μl. Results： The microscopic images were with strong specificity. The developed TLC spots were quite clear, and the method of TLC was simple with strong specificity and good reproducibility. The linear range of schisandrin was 21.17-423.40 ng（ r = 0.999 9）. The average recovery was 99.7% and the RSD was 1.4% （ n = 6）. Conclu- sion： The method for the quality control of Zengguang tablets is comprehensive and perfect.