[1] 伍立恒,李德款,连通,等.血浆相关因子对重组FⅧ稳定循环及降解途径的影响[J]. 药物生物技术,2023,30(3):234
WU LH, LI DK, LIAN T, et al. Effect of plasma related factors on the stable circulation and degradation pathway of recombinant FⅧ[J]. Pharm Biotechnol, 2023,30(3): 234
[2] 鲁丹,曾凡一.长效重组人凝血因子Ⅷ研究现状及进展[J]. 生物工程学报,2018,34(1):34
LU D, ZENG FY. Status and advances of long-acting factor Ⅷ[J]. Chin J Biotechnol, 2018,34(1):34
[3] 韦薇,白玉,罗建辉.重组人凝血因子Ⅷ的质量研究与质量控制[J]. 中国生物制品学杂志,2016,29(6):660
WEI W, BAI Y, LUO JH. Considerations on quality research and quality control of recombinant human coagulation factor Ⅷ[J]. Chin J Biol,2016,29(6):660
[4] 张瑶,马爱霞.重组人凝血因子Ⅷ的小剂量预防方案对比按需治疗方案用于中国A型血友病患者的成本-效用分析[J]. 中国药物经济学,2021,16(7):62
ZHANG Y, MA AX. Cost-utility analysis of low-dose prophylaxis vs on-demand treatment of recombinant human coagulation factor Ⅷ for Chinese patients with type A hemophilia[J]. Chin J Pharm Econ,2021,16(7):62
[5] 王艺诺,范潇予,滑曼曼,等.注射用重组人凝血因子Ⅷ大鼠单次与反复给药毒性研究[J]. 毒理学杂志,2018,32(4):301
WANG YN, FAN XY, HUA MM, et al. Acute and sub-chronnic toxicity studies of recombinant human coagulation factor Ⅷ for injection in rats[J]. J Toxicol, 2018,32(4):301
[6] 周荣富,李倩,欧阳建,等.第三代全长链重组凝血因子Ⅷ预防治疗中间型重型血友病A患儿疗效和安全性评估[J]. 中国实用儿科杂志,2017,32(1):59
ZHOU RF, LI Q, OUYANG J, et al. Efficacy and safety of third-generation full length recombinant human coagulation factor Ⅷ in the prophylactic treatment of childhood patients with moderate-to-severe hemophilia A: a single center experience[J]. Chin J Pract Pediatr,2017,32(1):59
[7] 王艺霖,徐英蕾,刘世国,等.血友病A病人FⅧ基因突变的检测[J]. 青岛大学医学院学报,2017,53(2):143
WANG YL, XU YL, LIU SG, et al. Detection of FⅧ gene mutation in patient with hemophilia A: report of one case[J]. Acta Acad Med Qingdao Univ, 2017,53(2):143
[8] 高爽.注射用重组人凝血因子Ⅷ治疗血友病A的护理分析[J]. 中国现代医生,2018,56(2):153
GAO S. Nursing analysis of hemophilia A treated with recombinant human coagulation factor Ⅷ for injection[J]. Chin Mod Doct, 2018,56(2):153
[9] 王诗轩,孙竞,李长钢,等.重组人凝血因子Ⅷ治疗411例中重型血友病A患者的抑制物产生及安全性的回顾性分析[J]. 临床血液学杂志,2018,31(1):29
WANG SX, SUN J, LI CG, et al. Evaluation of safety and inhibitor development of recombinant factor Ⅷ treatment in hemophilia A patients:a retrospective nationwide multicenter analysis in China[J]. J Clin Hematol,2018,31(1):29
[10] 中华人民共和国药典 2020 年版.四部[S]. 2020 ChP 2020.Vol Ⅳ[S]. 2020
[11] 陈蕾,康笑博,宋宗华,等.《中国药典》2020年版第四部药用辅料和药包材标准体系概述[J]. 中国药品标准,2020,21(4):307
CHEN L, KANG XB, SONG ZH, et al. Standard system of the pharmaceutical excipients and packaging materials in the Chinese pharmacopoeia 2020[J]. Drug Stand China,2020,21(4): 307
[12] International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Q3D: Guideline for Elemental Impurities[EB/OL]. (2022-03-08)[2023-04-07]. https://database.ich.org/sites/default/files/Q3D-R2_Guideline_Step4_2022_0308.pdf
[13] 李烨,张毅兰.通过加速试验考察不同介质对药用玻璃容器形成脱片的影响[J]. 中国医药工业杂志,2015,46(3):293
LI Y, ZHANG YL. Delamination propensity of pharmaceutical glass containers treated with different rxtraction media by accelerated testing[J]. Chin J Pharm,2015,46(3):293
[14] 潘叙恩,张译方,张春华,等.丙泊酚注射液与中性硼硅玻璃安瓿包材相容性研究[J]. 中国测试,2017,43(5):45
PAN XE, ZHANG YF, ZHANG CH, et al. Evaluating compatibility between propofol injection and neutral borosilicate glass ampoule[J]. China Meas Test,2017,43(5):45
[15] 孙会敏,李樾,赵霞,等.注射剂与药用玻璃包装容器相容性研究试验方法指南[J]. 中国药事,2018,32(9):1189
SUN HM, LI Y, ZHAO X, et al. Technical guidelines on experimental methods for the compatibility between injections and pharmaceutical glass packaging containers[J]. Chin Pharm Aff,2018,32(9):1189
[16] YBB00292005-2-2015中性硼硅玻璃管制注射剂瓶[S]. 2015
YBB00292005-2-2015 Injection Vials Made of Middle Borosilicate Glass Tubing[S]. 2015
[17] 潘云雪,陈成飞,金朦娜,等.ICP-MS测定明胶空心胶囊中铅、铬、镉、砷、铜的含量[J]. 中国现代应用药学,2014,31(3):339
PAN YX, CHEN CF, JIN MN, et al. Determination of Pb, Cr, Cd, As and Cu in vacant gelatin capsules by ICP-MS[J]. Chin J Mod Appl Pharm,2014,31(3):339
[18] 刘杰,李耀磊,昝珂,等.冬虫夏草人工繁育品和野生冬虫夏草中5种重金属及有害元素含量的比较[J]. 中国药事,2016,30(9):912
LIU J, LI YL,ZAN K, et al. A comparative study in the content of Pb, Cd, As, Hg and Cu between cultivated and natural cordyceps sinensis[J]. Chin Pharm Aff,2016,30(9):912
[19] 姜涛,施枝江,陈林明,等.ICP-MS法测定枸杞子5种金属元素的含量分析[J]. 亚太传统医药,2018,14(8):41
JIANG T,SHI ZJ, CHEN LM, et al. Content determination and analysis of 5 heavy metal elements in Lycium barbarum L. by ICP-MS[J]. Asia Pac Tradit Med,2018,14(8):41
[20] 王建波,柴昌信,黄兴华,等.电感耦合等离子体质谱法测定磷矿石中锰、铜、铅、锌、铬、镉[J]. 分析测试技术与仪器,2015,21(4):270
WANG JB, CHAI CX, HUANG XH, et al. Determination of manganese, copper, lead, zinc, chromium and cadmium in phosphate rock by inductively coupled plasma mass spectrometry[J]. Anal Test Technol Instrum,2015,21(4):270
[21] GB31604.49-2016 食品安全国家标准:食品接触材料及制品砷、镉、铬、铅的测定和砷、镉、铬、镍、铅、锑、锌迁移量的测定[S]. 2016:10
GB31604.49-2016 National Standard for Food Safety: Food Contact Materials and Products-Determination of As, Cd, Cr, Pb and Migration of As, Cd, Cr, Ni, Pb, Sb, Zn[S]. 2016:10
