[1] 中华人民共和国药典 2015年版. 二部[S].2015: 787
ChP 2015. Vol Ⅱ[S].2015: 787
[2] 中华人民共和国药典 2015年版. 三部[S].2015: 42
ChP 2015. Vol Ⅲ[S].2015: 42
[3] EP 10.0[S].2020: 2951
[4] USP 39[S].2016: 8646
[5] 王军志. 生物技术药物研究开发和质量控制[M].第3版. 北京: 科学出版社, 2018: 703
WANG JZ. Research, Development and Quality Control of Biopharmaceuticals[M].3rd Ed. Beijing: Science Press, 2018: 703
[6] HIRSCH IB, JUNEJA R, BEALS JM, et al. The evolution of insulin and how it informs therapy and treatment choices[J].Endocr Rev, 2020, 41(5): 733
[7] WANG CC, TSOU CL. The insulin A and B chains contain sufficient structural information to form the native molecule[J].Trends Biochem Sci, 1991, 16(8): 279
[8] WEISS MA, LAWRENCE MC. A thing of beauty: structure and function of insulin’s “aromatic triplet”[J].Diabetes Obes Metab, 2018, 20(Suppl 2): 51
[9] SELIVANOVA OM, GRISHIN SY, GLYAKINA AV, et al. Analysis of insulin analogs and the strategyof their further development[J].Biochemistry(Mosc), 2018, 83(Suppl 1): 146
[10] WHO Technical Report Series, No. 987, Annex 4: Guidelines on the Quality, Safety and Efficacy of Biotherapeutic Protein Products Prepared by Recombinant DNA Technology[EB/OL].(2014-06-18) [2021-06-20].https://www.who.int/publications/m/item/recombinant-dna-annex-4-trs-no-987
[11] 吕萍, 杨志行, 张慧, 等. CHO宿主细胞DNA残留检测试剂盒(PCR-Taqman探针法)的方法学验证[J].中国新药杂志, 2018, 27(21): 2519
L#xDC; P, YANG ZX, ZHANG H, et al. Validation of CHO host cell residual DNA quantitative kit(Q-PCR Taqman probe) [J].Chin J New Drugs, 2018, 27(21): 2519
[12] 中华人民共和国药典2020年版. 三部[S].2020: 凡例, 604, 553, 42
ChP 2020.Vol Ⅲ[S].2020: general notice, 604, 553, 42
[13] ICH Quality Guidelines, Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products[EB/OL]. (1999-03-10) [2021-06-20].https://www.ich.org/page/quality-guidelines
[14] USP 43-NF 38. Vol 4[S].2020: 6521(GC<89>: Enzymes Used As Ancillary Materials in Pharmaceutical Manufacturing)
[15] LIU M, WEISS MA, ARUNAGIRI A, et al. Biosynthesis, structure, and folding of the insulin precursor protein[J].Diabetes Obes Metab, 2018, 20(Suppl 2): 28
[16] 丁晓丽, 葛玉鹏, 张慧, 等. RP-HPLC法测定重组人胰岛素中胰岛素前体的含量[J].中国新药杂志, 2015, 24(15): 33
DING XL, GE YP, ZHANG H, et al. Determination of insulin precursor in recombinant human insulin by RP-HPLC[J].Chin J New Drugs, 2015, 24(15): 33
[17] 王绿音, 杨慧敏, 李晶, 等. 甘精胰岛素肽图分析方法研究[J].生物技术通讯, 2018, 29(5): 667
WANG LY, YANG HM, LI J, et al. Research of peptide mapping method for insulin glargine[J].Lett Biotechnol, 2018, 29(5):667
[18] 梁成罡,李晓东,张慧,等. 液质联用技术(LC-MS)在rh-PTH(1-34)肽图确定中的应用[J].药物分析杂志, 2005, 25(8): 949
LIANG CG, LI XD, ZHANG H, et al. Application of LC-MS in peptide mapping analysis of recombinant human parathyroid hormone 1-34[J].Chin J Pharm Anal, 2005, 25(8): 949
[19] 李晶, 梁成罡, 张慧, 等. 重组甘精胰岛素相关杂质的结构确认及质量分析[J].中国药学杂志, 2008, 43(20): 1588
LI J, LIANG CG, ZHANG H, et al. Structure identification and quality analysis of relative impurities of recombinant insulin glargine[J].Chin Pharm J, 2008, 43(20): 1588
[20] 程速远, 赛文博, 魏开坤, 等. 胰岛素类产品药学研究基本技术要求的考虑[J].中国新药杂志, 2020, 29(21): 6
CHENG SY, SAI WB, WEI KK, et al. Consideration of basic technical requirements for pharmaceutical research of insulin and its analogues[J].Chin J New Drugs, 2020, 29(21): 6
[21] BRANGE J, LANGKJAER L, HAVELUND S, et al. Chemical stability of insulin. 1. Hydrolytic degradation during storage of pharmaceutical preparations[J].Pharm Res, 1992, 9(6):715
[22] XU J, WU M, GONG Q, et al. Separation and identification of B3 and B3iso desamido human insulin in recombinant human insulin injection[J].J Instrum Anal, 2015, 34(10): 1173
[23] MCDONALD NQ, MURRAY-RUST J, BLUNDELL TL. The first structure of a receptor tyrosine kinase domain:a further step in understanding the molecular basisof insulin action[J].Structure, 1995, 3: 16
[24] 李克坚, 杨化新, 梁成罡, 等. 重组人甲状旁腺激素效价测定方法的研究[J].药物生物技术, 2005, 12(1): 43
LI KJ, YANG HX, LIANG CG, et al. Comparative study on the biological activity of recombinant human parathyroid hormone(rh-PTH1-34) with different detective methods[J].Pharm Biotechnol, 2005, 12(1): 43
[25] WANG LY, LIANG CG, YANG HM, et al. Development of a robust reporter gene-based assay for the bioactivity determination of recombinant human follicle stimulating hormone(rhFSH) pharmaceutical products[J].J Pharm Biomed Anal, 2020, 177: 112855. doi: 10.1016/j.jpba.2019.112855
[26] HARTREE AS, RENWICK AGC. Molecular structures of glycoprotein hormones and functions of their carbohydrate components[J].Biochem J, 1992, 287: 665
[27] HORSMAN G, TALBOT JA, MCLOUGHLIN JD, et al. A biological, immunological and physico-chemical comparison of the current clinical batches of the recombinant FSH preparations Gonal-F and Puregon[J].Hum reprod, 2000, 15(9): 1898
[28] GERVAIS A, HAMMEL YA, PELLOUX S, et al. Glycosylation of human recombinant gonadotrophins: characterization andbatch-to-batch consistency[J].Glycobiology, 2003, 13(3): 179
[29] 李晶, 何辉, 程速远, 等. 液相肽图法推断聚乙二醇化重组人生长激素的聚乙二醇修饰位点研究[J].中国药学杂志, 2012, 47(8): 626
LI J, HE H, CHENG SY, et al. RP-HPLC peptide mapping to determine pegylation sites of PEG-rhGH[J].Chin Pharm J, 2012, 47(8): 626
[30] 李晶, 何辉, 程速远, 等. 多种PEG化重组人生长激素中蛋白含量测定的通用型方法的建立[J].药物分析杂志, 2014, 34(9): 1556
LI J, HE H, CHENG SY, et al. Establishment of a general method to determine the protein content of various PEG-rhGHs[J].Chin J Pharma Anal, 2014, 34(9): 1556
[31] QIN XF, LI J, LI Y, et al. Isoform separation and structural identification of mono-PEGylated recombinant human growth hormone(PEG-rhGH) with pH gradient chromatography[J].J Chromatogr B Analyt Technol Biomed Life Sci, 2017, 1044-1045: 206