摘要
目的以中成药乙肝解毒胶囊为例,建立高效液相色谱-二极管阵列检测器检测法,测定硬胶囊囊壳中9种人工合成色素(着色剂)的含量。方法采用HPLC-DAD法对柠檬黄、日落黄、苋菜红、胭脂红、赤藓红、亮蓝、喹啉黄、偶氮玉红和诱惑红等9种水溶性色素进行测定,色谱柱为Agilent Zorbax Extend C18(250 mm×4.6 mm,5μm),流动相为甲醇-20 mmol/L乙酸铵溶液梯度洗脱,流速为1.0 ml/min,柱温35℃,进样体积5μl。结果各色素及相应色谱峰分离效果较好,在8.74~960 ng范围内呈良好线性关系(r=0.9997~1.0000),加样回收率为90.42%~104.07%。26批次样品囊壳中均有1~5种色素检出,其中13批检出色素>3种,15批色素总使用量高于0.5%。结论胶囊囊壳中着色剂使用有待统一规范,本实验方法可用于相关药品及保健品硬胶囊囊壳的质量控制。
Objective To establish an HPLC-DAD method for the determination of 9 artificial synthetic colorants used in shells of hard capsule,with traditional Chinese materia medica Yigan Jiedu capsule used as a case study.Methods Nine water-soluble colorants,tartrazine,sunset yellow,amaranth,ponceau 4 R,erythrosine,brilliant blue,quinoline yellow,azorubine and allura red,were determined by the HPLC-DAD method. The column was Agilent Zorbax Extend C18(250 mm×4.6 mm,5 μm),the mobile phase was the methanol-20 mmol/L ammonium acetate solution in gradient elution,the flow rate was 1.0 ml/min,the column temperature was 35℃,and the injected sample solution volume was 5 μl.Results The chromatographic peaks of all colorants were well separated and showed a good linearity in the range of 8.74-960 ng(r=0.9997~1.0000),and the recovery of nine colorants was 90.42%-104.07%. Total 1-5 kinds of colorants were detected in 26 batches of samples,among which, more than 3 kinds of colorants were detected in 13 batches of samples and 15 batches of samples contained more than 0.5% of total colorant content.Conclusion The use of colorant in capsule shells needs to be standardized,and the present method might be used for the quality control of hard capsule shells used in the drugs and health products.
作者
刘洪超
栾永福
焦阳
林林
林永强
LIU Hong-chao;LUAN Yong-fu;JIAO Yang;LIN Lin;LIN Yong-qiang(Key Laboratory for Gelatin Products Quality Evaluation of National Medical Products Administration,Shandong Provincial Institude for Food and Drug Control,Jinan 250101,China)
出处
《国际药学研究杂志》
CAS
北大核心
2020年第1期67-71,共5页
Journal of International Pharmaceutical Research
基金
山东省自然科学基金资助项目(ZR2013HM074)
2018年度国家药品评价抽验专项。
