原子吸收法测定中药片剂中铁含量及限量标准讨论

目的：建立中药片剂中铁含量测定的原子吸收光谱测定法，并建议限度要求。方法：采用浓硝酸-微波消解样品，火焰原子吸收光谱法建立校准曲线，并进行样品测定。结果：铁在浓度为1~5 μg·mL^-1的范围内线性关系良好（r=0.9997），平均回收率（n=9）为103.8%，方法的检出限为0.016 mg·g^-1。结论：该方法经方法学验证能满足日常分析检测的需要。根据样品普查数据，结合国外相关限量标准，建议中药片剂中的铁含量限度定为3 mg·g^-1。

Objective: To establish a determination method of iron content in medicine tablets by atomic absorption spectrometry,and to propose limit requirements. Methods: The samples were digested by HNO₃-microwave,calibration curves were established by flame atomic absorption spectrometry,and the samples were determined. Results: Concentration of iron in the range of 1-5 μg·mL^-1 showed good linear relationship(r=0.9997);the average recovery(n=9)was 103.8%,and the detection limit of the method was 0.016 mg·g^-1. Conclusion: The methodology validation showed that this method could meet the needs of regular analysis and testing of the traditional Chinese medicine tablets.According to the sample data,combined with the relevant standards,the limit of iron content in traditional Chinese medicine tablets was set at 3 mg·g^-1.