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目的:建立反相高效液相色谱法测定药品与保健品的囊壳中合成色素的检测方法。方法:将药品和保健品的囊壳剪开,挤出内容物,用三氯甲烷洗净囊壳上附着的内容物,用水浸泡囊壳来提取水溶性的合成色素。采用ZORBAX E-clipse XDB-C18反相柱,以甲醇和乙酸铵为流动相,采用梯度洗脱、改变波长的方法进行测定。结果:在所检测的药品和保健品的囊壳中均有色素检出,但所添加的合成色素的种类各不相同。在样品中分别加入了不同的5种合成色素标准即柠檬黄、苋菜红、胭脂红、日落黄、亮蓝,回收率在90.5%～102.8%。结论:采用反相高效液相色谱法对保健品囊壳中合成色素进行分离检测,灵敏度较高,各色素分离度良好、回收率满意,适于药品与保健品囊壳中合成色素的测定。
Objective: To establish a method for the determination of synthetic pigment in the capsule shell of drugs and health products by reversed-phase high performance liquid chromatography. Methods: The shell of medicines and health products were cut open, the contents were extruded, the contents attached to the shell were washed with chloroform, and the water-soluble synthetic pigment was extracted by soaking the shell with water. Using ZORBAX E-clipse XDB-C18 reversed-phase column, methanol and ammonium acetate as the mobile phase, using a gradient elution, changing the wavelength of determination. Results: Pigments were detected in the capsule shells of the tested drugs and health products, but the types of the synthetic dyes added were different. In the sample were added a different five kinds of synthetic pigment standards that lemon yellow, amaranth, carmine, sunset yellow, bright blue, the recovery rate of 90.5% ~ 102.8%. Conclusion: RP-HPLC method is applied to the separation and detection of synthetic pigment in capsule shell of health care products. It has high sensitivity, good resolution and satisfactory recovery rate. It is suitable for the determination of synthetic pigment in the capsule of capsule and nutraceutical.