目的: 通过考察原淀粉和改性淀粉类药用辅料中的硝酸盐和亚硝酸盐,来探讨辅料对药品中亚硝胺类杂质形成的影响。方法: 采用离子色谱法测定硝酸盐和亚硝酸盐的含量。采用Dionex IonPac AS11-HC（4 µm,2 mm×250 mm）色谱柱,电导检测器,抑制电导检测,流动相为0.015 mol · L-1 氢氧化钾溶液,流速为1.0 mL · min-1,柱温为30 ℃,进样体积为25 µL。对方法的专属性、线性、检测限和定量限、精密度、准确度和耐用性进行了验证。结果: 对9种共119批原淀粉和改性淀粉样品进行了测定,硝酸盐在所有38批原淀粉中均有检出,含量为1~70 µg · g-1;在55批（共81批）改性淀粉中也有检出,含量为2~1 110 µg · g-1,其中糊精的硝酸盐含量最高。亚硝酸盐在33批原淀粉中有检出,含量为0.3~2.5 µg · g-1;在17批改性淀粉中有检出,含量为1.1~13.0 µg · g-1。结论: 该方法经验证,适用于测定淀粉类药用辅料中的硝酸盐和亚硝酸盐。辅料中的硝酸盐和亚硝酸盐控制是药物制剂亚硝胺杂质风险控制的一个重要部分,应给予充分重视。
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