乳癖康胶囊质量标准研究

Quality Standard for 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=0.999 9,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。

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 0.160.4 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.