乳癖康胶囊质量标准研究

摘要

Objective To establish the quality standard for Rupikang Capsules. Methods Lumbricus were identified by TLC. Tanshinone IIA was determined by HPLC. HPLC analysis was carried out on Hitachi L-2000 C18 column (250 mm×4.6 mm, 5 µm) and the mixture of methanol-water (75∶25) was used as the mobile phase, the flow rate was 1.0 mL/min and the detection wavelength was at 270 nm. Results TLC spots developed were fairly clear and the blank test showed no interference. The linear range was 0.16-0.4 µg for tanshinone ⅡA, r=0.999 9. The average recovery was 99.1%, RSD=2.20%. Conclusion The methods is easy to operate, with good specificity and reproducibility. It can be used for the quality control of Rupikang Capsules.%目的建立乳癖康胶囊的质量标准。方法用薄层色谱法对乳癖康胶囊中地龙进行定性鉴别。用高效液相色谱法测定制剂中丹参酮ⅡA的含量,色谱柱为日立L-2000 C18柱(250 mm×4.6 mm,5µm),流动相为甲醇-水(75∶25),流速为1.0 mL/min,检测波长为270 nm。结果在薄层色谱中能检出地龙,阴性对照无干扰。丹参酮ⅡA在0.16～0.4µg 范围内具有良好的线性关系,回归系数 r＝0.9999,平均回收率为99.1%,RSD＝2.20%。结论本方法简便可行,专属性强,重复性好,可用于乳癖康胶囊的质量控制。