重组人绒毛膜促性腺激素研究进展
|
摘要
目前治疗不孕症的主要手段是辅助生殖技术,人绒毛膜促性腺激素是重要的辅助生殖药物之一。第一代人绒毛膜促性腺激素药物是从妊娠期妇女尿液中提取的尿源人绒毛膜促性腺激素(Urinary human chorionic gonadotropin,u-hCG);第二代人绒毛膜促性腺激素药物是通过基因重组技术,在CHO细胞(Chinese hamster ovary cell,中国仓鼠卵巢细胞)中表达获取的重组人绒毛膜促性腺激素(Recombinant human chorionic gonadotropin,r-hCG)。相比于u-hCG,r-hCG具有纯度高,患者耐受性良好,来源不受限等优势,文章综述r-hCG制备及质量研究方法进展,并对国内h CG产品市场现状及发展趋势进行分析。
At present,the main means of treating infertility was assisted reproductive technique. The first generation of h CG drugs is u-hCG( urinary h CG),which was extracted from urine of pregnant women. The second generation,r-hCG( recombinant h CG),was expressed by Chinese hamster ovary cells engineered with gene recombination technique. Compared with u-hCG,r-hCG had high purity and patient tolerance,as well as endless resources. The development of r-hCG preparation and quality research methods was reviewed,and domestic h CG products market situation and development trend were analyzed in this paper.
At present,the main means of treating infertility was assisted reproductive technique. The first generation of h CG drugs is u-hCG( urinary h CG),which was extracted from urine of pregnant women. The second generation,r-hCG( recombinant h CG),was expressed by Chinese hamster ovary cells engineered with gene recombination technique. Compared with u-hCG,r-hCG had high purity and patient tolerance,as well as endless resources. The development of r-hCG preparation and quality research methods was reviewed,and domestic h CG products market situation and development trend were analyzed in this paper.
引文
[1] Inhorn MC,Patrizio P. Infertility around the globe:new thinking on gender,reproductive technologies and global movements in the21st century[J]. Hum Reprod Update,2015,21(4):411-426.
[2] Isaacs NW,Lapthorn AJ,Harris DC,et al. Crystal structure of human chorionic gonadotropin[J]. Nature,1994,369:9:455-461.
[3]高丽婷,周莉婷,王俊玲,等.长效卵泡刺激素研究进展[J].中国新药杂志,2014,23(20):2418-2423.
[4] Green Eric D. Differential processing of Asn-linked oligosaccharides on pituitary glycoprotein hormones implications for biologic function[J]. Mol Cell Biochem,1986,(72):81-100.
[5] Piani D,Malkowski JP. Recombinant hCG(OVIDRELTM)and recombinant Interferon(REBIF)(No. 13 in a series of articles to promote a better understanding of the use of genetic engineering[J]. J Biotechnol,2001,87(3):279-284.
[6]马玺. r-hCG的研制及其相关分子对肿瘤细胞体外生长的影响[D].南京:军事医学科学院,2008.
[7] Liu Y,Yi X,Zhuang Y,et al. Limitations in the process of transcription and translation inhibit recombinant human chorionic gonadotropin expression in CHO cells[J]. J Biotechnol,2015,204:63-69.
[8]刘扬. CHO细胞表达重组人绒毛膜促性腺激素的调控机理研究[D].上海:华东理工大学,2014.
[9]阎哲,黄骏雄.激素的不均一性及其色谱分离纯化研究的进展[J].化学进展,1999,11(2):163-171.
[10] Hermans P Adams H,Detmers F. Purification of antibodies and antibody fragments using Capture SelectTMaffinity resins[J].Methods Mol Biol,2014,1131:297-314.
[11] CaptureSelectTMh CG Affinity Matrix[EB/OL].[2014-04-10]https://www. thermofisher. com/order/catalog/product/194341005.
[12] Thennati R,Singh SK,Nage N,et al. Analytical characterization of recombinant hCG and comparative studies with reference product[J]. Biologics:Targets Therapy,2018,12:23-35.
[13] Gervais A,Hammel YA,Pelloux S,et al. Glycosylation of human recombinant gonadotrophins:characterization and batch-to-batch consistency[J]. Glycobiol,2003,13(3):179-189.
[14] Zhu H,Qiu C,Ruth AC,et al. A LC-MS all-in-one workflow for site-specific location,identification and quantification of N-/Oglycosylation in human chorionic gonadotropin drug products[J].AAPS J,2017,19(3):846-855.
[15] Kwang Seok Seo,Jin Wook Yoon,Kyu Heum Na,et al. Evaluation of process efficiency and bioequivalence of biosimilar recombinant human chorionic gonadotropin(rhCG)[J]. Biodrugs,2011,25(2):115-127.
[16]国家药典委员会. ChP(中国药典)[S].北京:中国医药科技出版社,2015,Ⅱ(二部):455.
[17] Le2o RB,Esteves SC. Gonadotropin therapy in assisted reproduction:an evolutionary perspective from biologics to biotech[J].Clinics,2014,69(4):279-293.
[18] Birmingham,Alabama. Gonadotropin preparations:past,present,and future perspectives[J]. Fertil Steril,2008,90(5):13-20.
[19] Bagchus W,Wolna P,Wolfgang U. Single-dose pharmacokinetic study comparing the pharmacokinetics of recombinant human chorionic gonadotropin in healthy Japanese and Caucasian women and recombinant human chorionic gonadotropin and urinary human chorionic gonadotropin in healthy Japanese women[J].Reprod Med Biol,2018,17:52-58.
[20] Eftekhar M,Khalili MA,Rahmani E. The efficacy of recombinant versus urinary HCG in ART outcome[J]. Iran J Reprod Med,2012,10(6):543-548.
[21] Ikenaga H,Tanaka Y,Shiotani M,et al. Phase III trial comparing the efficacy and safety of recombinant-or urine-derived human chorionic gonadotropin for ovulation triggering in Japanese women diagnosed with anovulation or oligo-ovulation and undergoing ovulation inducton with follitropin-alfa[J]. Reprod Med Biol,2017,16(1):45-51.
[22] Youssef MA,Abou-Setta AM,WS Lam. Recombinant versus urinary human chorionic gonadotrophin for final oocyte maturation triggering in IVF and ICSI cycles(Review)[J]. Cochrane Database Syst Rev,2016,(4):81.
[23] Giudice E,Crisci C,Eshkol A,et al. Composition of commercial gonadotrophin preparations extracted from human post-menopausal urine:characterization of non-gonadotrophin proteins[J]. Hum Reprod,1994,9(12):2291-2299.
[24] Mulders JW,Bos ES,Verhaert PD,et al. Compositional analyses of a human menopausal gonadotrophin preparation extracted from urine(menotropin). Identification of some of its major impurities[J]. Reprod Biomed Online,2003,7(5):547-557.
[25] Kuwabara Y,Mine K Katayama A,Inagawa T,et al. Proteomic analyses of recombinant human follicle-stimulating hormone and urinary-derived gonadotropin preparations[J]. J Reprod Med,2009,54(8):459-466.
[26] Saunders H,Schertz JC,Hecker C,et al. The recombinant human chorionic gonadotropin prefilled pen:results of patient and nurse human factors usability testing[J]. Expert Opin Drug Deliv,2012,9(8):893-900.
[27] Nakagawa K,Oba M,Ehara K,et al. Clinical outcomes of assisted reproductive technology treatment by using a self-injection of recombinant human chorionic gonadotropin as the final maturation trigger[J]. Reprod Med Biol,2018,17(1):203-208.
[28] Ezcurra D,Humaidan P. A review of luteinising hormone and human chorionic gonadotropin when used in assisted reproductive technology[J]. Reprod Biol Endocrin,2014,12(95):12.
[29]王秀萍,焦琳,郭红燕.人绒毛膜促性腺激素的临床应用进展[J].药学服务与研究,2010,10(3):185-189.
[2] Isaacs NW,Lapthorn AJ,Harris DC,et al. Crystal structure of human chorionic gonadotropin[J]. Nature,1994,369:9:455-461.
[3]高丽婷,周莉婷,王俊玲,等.长效卵泡刺激素研究进展[J].中国新药杂志,2014,23(20):2418-2423.
[4] Green Eric D. Differential processing of Asn-linked oligosaccharides on pituitary glycoprotein hormones implications for biologic function[J]. Mol Cell Biochem,1986,(72):81-100.
[5] Piani D,Malkowski JP. Recombinant hCG(OVIDRELTM)and recombinant Interferon(REBIF)(No. 13 in a series of articles to promote a better understanding of the use of genetic engineering[J]. J Biotechnol,2001,87(3):279-284.
[6]马玺. r-hCG的研制及其相关分子对肿瘤细胞体外生长的影响[D].南京:军事医学科学院,2008.
[7] Liu Y,Yi X,Zhuang Y,et al. Limitations in the process of transcription and translation inhibit recombinant human chorionic gonadotropin expression in CHO cells[J]. J Biotechnol,2015,204:63-69.
[8]刘扬. CHO细胞表达重组人绒毛膜促性腺激素的调控机理研究[D].上海:华东理工大学,2014.
[9]阎哲,黄骏雄.激素的不均一性及其色谱分离纯化研究的进展[J].化学进展,1999,11(2):163-171.
[10] Hermans P Adams H,Detmers F. Purification of antibodies and antibody fragments using Capture SelectTMaffinity resins[J].Methods Mol Biol,2014,1131:297-314.
[11] CaptureSelectTMh CG Affinity Matrix[EB/OL].[2014-04-10]https://www. thermofisher. com/order/catalog/product/194341005.
[12] Thennati R,Singh SK,Nage N,et al. Analytical characterization of recombinant hCG and comparative studies with reference product[J]. Biologics:Targets Therapy,2018,12:23-35.
[13] Gervais A,Hammel YA,Pelloux S,et al. Glycosylation of human recombinant gonadotrophins:characterization and batch-to-batch consistency[J]. Glycobiol,2003,13(3):179-189.
[14] Zhu H,Qiu C,Ruth AC,et al. A LC-MS all-in-one workflow for site-specific location,identification and quantification of N-/Oglycosylation in human chorionic gonadotropin drug products[J].AAPS J,2017,19(3):846-855.
[15] Kwang Seok Seo,Jin Wook Yoon,Kyu Heum Na,et al. Evaluation of process efficiency and bioequivalence of biosimilar recombinant human chorionic gonadotropin(rhCG)[J]. Biodrugs,2011,25(2):115-127.
[16]国家药典委员会. ChP(中国药典)[S].北京:中国医药科技出版社,2015,Ⅱ(二部):455.
[17] Le2o RB,Esteves SC. Gonadotropin therapy in assisted reproduction:an evolutionary perspective from biologics to biotech[J].Clinics,2014,69(4):279-293.
[18] Birmingham,Alabama. Gonadotropin preparations:past,present,and future perspectives[J]. Fertil Steril,2008,90(5):13-20.
[19] Bagchus W,Wolna P,Wolfgang U. Single-dose pharmacokinetic study comparing the pharmacokinetics of recombinant human chorionic gonadotropin in healthy Japanese and Caucasian women and recombinant human chorionic gonadotropin and urinary human chorionic gonadotropin in healthy Japanese women[J].Reprod Med Biol,2018,17:52-58.
[20] Eftekhar M,Khalili MA,Rahmani E. The efficacy of recombinant versus urinary HCG in ART outcome[J]. Iran J Reprod Med,2012,10(6):543-548.
[21] Ikenaga H,Tanaka Y,Shiotani M,et al. Phase III trial comparing the efficacy and safety of recombinant-or urine-derived human chorionic gonadotropin for ovulation triggering in Japanese women diagnosed with anovulation or oligo-ovulation and undergoing ovulation inducton with follitropin-alfa[J]. Reprod Med Biol,2017,16(1):45-51.
[22] Youssef MA,Abou-Setta AM,WS Lam. Recombinant versus urinary human chorionic gonadotrophin for final oocyte maturation triggering in IVF and ICSI cycles(Review)[J]. Cochrane Database Syst Rev,2016,(4):81.
[23] Giudice E,Crisci C,Eshkol A,et al. Composition of commercial gonadotrophin preparations extracted from human post-menopausal urine:characterization of non-gonadotrophin proteins[J]. Hum Reprod,1994,9(12):2291-2299.
[24] Mulders JW,Bos ES,Verhaert PD,et al. Compositional analyses of a human menopausal gonadotrophin preparation extracted from urine(menotropin). Identification of some of its major impurities[J]. Reprod Biomed Online,2003,7(5):547-557.
[25] Kuwabara Y,Mine K Katayama A,Inagawa T,et al. Proteomic analyses of recombinant human follicle-stimulating hormone and urinary-derived gonadotropin preparations[J]. J Reprod Med,2009,54(8):459-466.
[26] Saunders H,Schertz JC,Hecker C,et al. The recombinant human chorionic gonadotropin prefilled pen:results of patient and nurse human factors usability testing[J]. Expert Opin Drug Deliv,2012,9(8):893-900.
[27] Nakagawa K,Oba M,Ehara K,et al. Clinical outcomes of assisted reproductive technology treatment by using a self-injection of recombinant human chorionic gonadotropin as the final maturation trigger[J]. Reprod Med Biol,2018,17(1):203-208.
[28] Ezcurra D,Humaidan P. A review of luteinising hormone and human chorionic gonadotropin when used in assisted reproductive technology[J]. Reprod Biol Endocrin,2014,12(95):12.
[29]王秀萍,焦琳,郭红燕.人绒毛膜促性腺激素的临床应用进展[J].药学服务与研究,2010,10(3):185-189.