14批抗生素胶囊剂囊壳中人工合成色素的检测结果分析

Analysis on the Testing Results of Synthetic Colorants from Fourteen Batches of Antibiotic Capsule Shells

目的应用现行国家标准检测14批抗生素胶囊剂囊壳中人工合成色素,并对检测结果进行分析。方法选取胶囊壳颜色具有代表性的市售5种常用口服抗生素胶囊剂,除净内容物,水浸法提取水溶性人工合成色素,利用GB/T 5009.35-2003《食品中合成着色剂的测定》第一法HPLC法进行检测。结果14批常用抗生素胶囊剂囊壳中均检出国家标准GB 2760-2011允许使用的人工合成色素,主要有柠檬黄、胭脂红、日落黄和亮蓝4种。不同颜色的胶囊囊壳,所添加的人工合成色素种类各不相同。结论该方法灵敏度较高,各色素分离良好,回收率满意。检测结果提示,加强药用胶囊中人工合成色素的监管势在必行。

Objective To determine the synthetic colorants approved by GB2760 in 14 batches of antibiotic capsule shells by current national standards, and analyze the test results. Methods Five kinds of commercially available commonly used oral antibiotic capsules with representative colors were selected. The capsule contents were cleaned out and the water-soluble synthetic colorants were abstracted by distilled water. HPLC method, the first method from ＂ The determination of synthetic color in foods agent＂ （GB/TS009. 35） was used for detection. Results The synthetic colorants approved by GB2760 were detected, including the four main colorants-Tartrazine, Sunset Yellow FCF, Ponceau 4R and Brillant Blue FCF. Capsule shells of different colors had different types of synthetic colorants added. Conclusion The established method is sensitive, and has good separation and recovery of the components . Our result also suggests that it is imperative to strengthen the supervision of synthetic colorants in medicinal capsules.