[1] DIETRICH H, MIRJANA V D, ABRAHAM R, et al. A study of tobaccocarcinogenesis. LI. Relative potencies of tobacco-specific N-nitrosamines as inducers of lung tumours in AJ mice[J]. Cancer Lett, 1993, 71(1/2/3): 25-30. [2] HYOUNG S L. Literature compilation of volatile N-nitrosamines in processed meat and poultry products-an update[J]. Food Addit Contam Part A, 2019, 36(10): 1491-1500. [3] BEI E, SHU Y Y, LI S X, et al. Occurrence of nitrosamines and their precursors in drinking water systems around mainland China[J]. Water Res, 2016, 98: 168-175. [4] OWEN D. All ranitidine should be discarded, says US drug agency[J].Brit Med J, 2020, 369: m1390. [5] 闾春林, 刘永东, 王云海, 等. 二甲胺与亚硝酸反应生成N,N-二甲基亚硝胺的理论研究[J]. 化学学报, 2007, 65(16): 1568-1572. LV C L, LIU Y D, WANG Y H, et al. Theoretical studies on the N-nitrosodimethylamine formation from dimethylamine and nitrous acid[J]. Acta Chim Sin, 2007, 65(16): 1568-1572. [6] SHANNON L, LEAVEY R, STUART W K, et al. The effect of natural organic matter polarity and molecular weight on NDMA formation from two antibiotics containing dimethylamine functional groups[J]. Sci Total Environ, 2016, 572: 1231-1237. [7] French national agency for medicines and health products safety laboratory controls division. Determination of NDMA and NDEA in sartan drug substances by HPLC/UV [EB/OL]. [2020-12-30]. https://www.edqm.eu/sites/default/files/method_19a0416-01_ndma_and_ndea_in_sartan_by_hplc-uv_-_ansm.pdf. [8] United states food and drug administration. Combined headspace N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), N-nitrosoethylisopropylamine (NEIPA), and N-nitrosodiisopropylamine (NDIPA) impurity assay by GC-MS/MS [EB/OL]. (2019-04-11) [2020-12-30]. https://www.fda.gov/media/123408/download. [9] United states food and drug administration. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of NDMA in ranitidine drug substance and solid dosage drug product [EB/OL]. (2019-10-17) [2020-12-30]. https://www.fda.gov/media/131868/download. [10] United states food and drug administration. Liquid chromatography-electrospray ionization-high resolution mass spectrometry (LC-ESI-HRMS) method for the determination of nitrosamine impurities in metformin drug substance and drug product [EB/OL]. (2020-06-03) [2020-12-30]. https://www.fda.gov/media/138617/download. [11] United states food and drug administration. Combined direct injection N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), N-nitrosoethylisopropylamine (NEIPA), N-nitrosodiisopropylamine (NDIPA), and N-nitrosodibutylamine (NDBA) impurity assay by GC-MS/MS[EB/OL]. (2019-04-19)[2020-12-30]. https://www.fda.gov/media/123409/download. [12] 郭常川,刘琦,张雷,等. 高效液相色谱-串联质谱法测定盐酸二甲双胍及其制剂中痕量N-亚硝基二甲胺[J]. 色谱, 2020, 38(11): 1288-1293. GUO C C, LIU Q, ZHANG L, er al. Determination of N-nitrosodimethylamine in metformin hydrochloride and its preparations by high performance liquid chromatography-tandem mass spectrometry[J]. Chinese J Chromatogr, 2020, 38(11): 1288-1293. [13] 徐小力, 青旺旺, 邹佳佳, 等. 气相色谱-质谱联用法测定不同厂家盐酸二甲双胍缓释片中N-亚硝基二甲胺的含量[J]. 中国医院药学杂志, 2020, 40(24): 2531-2534. XU X L, QING W W, ZHOU J J, et al. Determination of N-nitrosodimethylamine in metformin hydrochloride sustained-release tablets from different manufacturers by gas chromatography-mass spectrometry[J]. Chinese J Hospital Pharm, 2020, 40(24): 2531-2534. [14] 董夫银. 用EXCEL进行线性回归分析及测量不确定度的计算[J]. 光谱实验室, 2005, 22(6): 1234-1238. DONG F Y. Linear regression analysis and calculation of uncertainty with excel software[J]. Chinese J Spectrosc Lab, 2005, 22(6): 1234-1238. [15] 冯闻铮, 亓平言, 周倜, 等. 螺旋霉素在酸碱溶液中的降解动力学[J]. 药学学报, 1997, 32(12): 934-937. FENG W Z, QI P Y, ZHOU T, et al. Study on the degradation kinetics of spiramycin in acid and alkaline solutions[J]. Acta Pharm Sin, 1997, 32(12): 934-937. [16] 金建闻, 张雪侠, 党明安, 等. 雷尼替丁产品中N-亚硝基二甲胺质量控制探讨[J]. 中国药事, 2020, 34(12): 1389-1395. JIN J W, ZHANG X X, DANG M A, et al. On the NDMA quality control of ranitidine products[J]. Chinese Pharm Aff, 2020, 34(12): 1389-1395. [17] POTTEGARD A, KRISTENSEN K B, ERNST M T, et al. Use of N-nitrosodimethylamine (NDMA) contaminated valsarton products and risk of cancer: danish nationwide cohort study[J]. Brit Med J, 2018, 362: K3851. [18] 韩莹, 王济禾, 李军, 等. 高效液相色谱同时测定水中四种亚硝胺类物质[J]. 中国给水排水, 2017, 33(6): 131-134. HAN Y, WANG J H, LI J, et al. Simultaneous determination of four kinds of nitrosamines in water by high performance liquid chromatography[J]. China Water Waste Water, 2017, 33(6): 131-134. [19] 陈忠林, 徐冰冰, 齐虹, 等. 高效液相色谱测定水中痕量亚硝基二甲胺[J]. 中国给水排水, 2007, 23(8): 84-87. CHEN Z L, XU B B, QI H, et al. Determination of trace nitrosodimethylamine in water by high high performance liquid chromatography[J]. China Water Waste Water, 2007, 23(8): 84-87. |