新疆医科大学学报

目的 测定脂肪乳注射液(C_14～24)中28种元素的含量及质量控制研究。方法 以费森尤斯卡比华瑞制药有限公司的脂肪乳注射液(C_14～24)作为样品，采用HNO₃-H_2O₂消解体系，湿法消解处理样品，以电感耦合等离子体质谱法(Inductively coupled plasma mass spectrometry, ICP-MS)测定25种元素的含量；以原子吸收分光光度法(Atomic absorption spectrophotometers, AAS)测定钠、钙、铁元素的含量，针对样品中3种元素偏高的问题，增加了对卵磷脂、大豆油两种原料中钠、钙、铁元素的检测，核实原料中的元素向样品迁移对其品质的影响。结果 方法学考察结果显示，重复性实验RSD在0.9%～5.0%范围内，精密度实验RSD在1.5%～4.9%范围内，回收率为80.5%～110.8%。脂肪乳注射液(C_14～24)样品中钠含量最高(71.790～98.830 mg/L),其次为钙(22.695～39.700 mg/L)、铁(2.793～4.265 mg/L)、钾(0.528 00～0.618 00 mg/L)、硼(0.025 60～0.068 10 mg/L);卵磷脂、大豆油中的钠含量较高，分别为406.375 mg/L和399.250 mg/L。其它微量元素含量较低，有害重金属含量均在检出限附近，符合药品安全相关要求。结论 本研究采用ICP-MS和AAS法测定了脂肪乳注射液(C_14～24)中28种元素的含量，该方法灵敏度高、准确性好、操作简便，为脂肪乳注射液(C_14～24)质量控制及元素组成特征研究提供了技术支撑。

Objective The contents of 28 elements in fat emulsion injection(C_14～24) were determined. Methods The fat emulsion injection(C_14～24) of Fresenius Kabi Huarui Pharmaceutical Co., Ltd.was used as the sample. The samples were digested by HNO₃-H2O₂ digestion system and wet digestion. The contents of 25 elements were determined by inductively coupled plasma mass spectrometry(ICP-MS). The content of sodium, calcium and iron was determined by atomic absorption spectrophotometers(AAS). In view of the high content of 3 elements in the sample, the detection of sodium, calcium and iron in lecithin and soybean oil was increased to verify the effect of the migration of elements in the raw materials on the quality of the preparation. Results The results of methodological investigation showed that the RSD of repeatability experiment was in the range of 0.9%-5.0%, the RSD of precision experiment was in the range of 1.5%-4.9%, and the recovery rate was 80.5% to 110.8%. The content of sodium in fat emulsion injection(C_14～24) was the highest(71.790-98.830 mg/L), followed by calcium(22.695-39.700 mg/L), iron(2.793-4.265 mg/L), potassium(0.528 00-0.618 00 mg/L) and boron(0.025 60-0.068 10 mg/L). The sodium content in lecithin and soybean oil was relatively high, which was 406.375 mg/L and 399.250 mg/L respectively. The content of other trace elements was low, and the content of harmful heavy metals were near the detection limit, which met the requirements of drug safety. Conclusion In this study, the contents of 28 elements in fat emulsion injection(C_14～24) are determined by ICP-MS and AAS methods. The method has high sensitivity, good accuracy and simple operation, which provides technical support for the quality control and elemental composition characteristics of fat emulsion injection(C_14～24).