心迪软胶囊质量标准研究

目的：建立心迪软胶囊的质量标准。方法：采用薄层色谱法对心迪软胶囊中槲皮素、山柰素和异鼠李素在同一薄层板上进行定性鉴别：硅胶G板，以氯仿-甲酸乙酯-甲酸（5∶4∶1）为展开剂进行展开；并采用高效液相色谱法对心迪软胶囊中的槲皮素、山柰素和异鼠李素同时进行含量测定: Diamonsil^TM(钻石) C₁₈（4.6 mm×250 mm，5 μm），乙腈-水-磷酸（30∶70∶0.1）为流动相，流速1 mL·min^-1，检测波长370 nm，柱温40 ℃。结果：通过薄层色谱可同时鉴别槲皮素、山柰素和异鼠李素3种黄酮苷元。槲皮素在0.412～1.648 μg线性关系良好，r=0.999 9, 平均回收率为96.8%，RSD为0.9%(n=6)；山柰素在0.021～0.083 μg线性关系良好，r=0.999 8，平均回收率为96.9%，RSD为2.0%(n=6)；异鼠李素在0.183～0.732 μg线性关系良好，r=0.999 9，平均回收率为97.1％，RSD为1.6%(n=6)。结论：所建立的心迪软胶囊质量标准研究方法可行，重复性好，能有效地控制该制剂的质量。

Quality standard for Xindi soft capsule

OBJECTIVE: To establish the quality control standard of Xindi soft capsule. METHOD: Quercetin, kaempferol and isorhamnetin were isolated by TLC with chloroform-ethyl formate-formic acid (5:4:1). The chromatographic separation was performed on a Diamonsil C18 column (4.6 mm x 250 mm, 5 microm). Acetonitrile-water-phosphoric (30:70:0.1) as mobile phase. The flow rate was 1 mL x min(-1) and column temperature was set at 40 degrees C. The UV detection wavelength was set at 254 nm. RESULT: Quercetin, Kaempferol and Isorhamnetin could be identified by TLC. Quercetin showed a good linear relationship at a range of 0.412-1.648 microg, r = 0.999 9, the average recovery was 96.8%, and RSD was 0.9% (n = 6). Kaempferol showed a good linear relationship at a range of 0.021-0.083 microg, r = 0.999 8, the average recovery was 96.9%, and RSD was 2.0% (n = 6). Isorhamnetin showed a good linear relationship at a range of 0.183-0.732 microg, r = 0.999 9, the average recovery was 97.1%, and RSD was 1.6% (n = 6). CONCLUSION: The method is accurate with the good reproducibility and can be used for the quality control of Xindi soft capsule.