关闭
 
读者在线:用户名 密码
首页 期刊简介 投稿须知 期刊目录 专家风采 编委会 特邀顾问 联系我们 移动出版
  1. 1
  2. 2
  3. 3
  4. 4
  5. 5



刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

访问统计
您是第  4 9 5 0 9 9 2 位浏览者
您当前的位置:首页 >> 正文

注射用醋酸亮丙瑞林缓释微球质量回顾与分析

Quality review and analysis of leuprorelin acetate sustained release microspheres for injection

分类号:R917
出版年·卷·期(页码):2020,40 (6):964-970
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的: 为注射用缓释微球制剂的质量研究和质控方法提供一定的参考。方法: 全球现有多家企业生产注射用醋酸亮丙瑞林缓释微球,其工艺、质量评价体系多不相同,本文根据多年对该品种检验及标准研究的结果,概述了不同生产工艺及质量评价体系下注射用醋酸亮丙瑞林缓释微球的质量状况,并对关键质量参数进行了对比和分析。结果: 注射用醋酸亮丙瑞林缓释微球质量基本稳定,不同企业产品间存在质量差异。结论: 注射用醋酸亮丙瑞林缓释微球现行质量标准可对其质量进行有效评估,但尚需进一步完善。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To provide a reference of quality research and quality control of sustained released microspheres for injection. Methods: The process and quality evaluation system of euprorelin acetate sustained release microspheres for injection from global different manufactures is different. Based on the results of testing and research on the species for many years,this paper summarized the quality status of leuprorelin acetate microspheres for injection under different production processes and quality evaluation system. The key quality parameters(particle size and distribution,pH,residual organic solvents,dissolution,related substances,assay) are compared and analyzed. Results: The quality of leuprorelin acetate microspheres for injection imported is stable,and there are quality differences among products from different manufactures. Conclusion: .The existing quality system of leuprorelin acetate microspheres for injection can be used to evaluate their quality effectively,but further improvement is needed.

-----参考文献:---------------------------------------------------------------------------------------

[1] 郭宁子,辛中帅,杨化新.微球制剂质量控制研究进展[J].中国新药杂志,2015,24(18):2115 GUO NZ,XIN ZS,YANG HX.Research progress in quality control of microspheres[J].Chin J New Drugs,2015,24(18):2115
[2] 徐明新,陶颖,陈园园.长效缓释微球制剂生产技术的发展现状[J].现代生物医学进展,2017,17(19):3772 XU MX,TAO Y,CHEN YY.Advanced Studies in the preparation techniques of sustained-release microsphere[J].Progr Mod Biomed,2017,17(19):3772
[3] 梅兴国,黄似焕,白承之.注射用缓释微球的国内外发展现状[J].药物研究,2014,31(1):27 MEI XG,HUANG SH,BAI CZ.Worldwide development status of injectable microspheres for sustained release[J].Pharm Res,2014,31(1):27
[4] 梁苑英竹,林晓鸣,刘万卉,等.肽类微球注射剂释放度实验评价研究进展[J].中国新药杂志,2017,26(24):2918 LIANG YYZ,LIN XM,LIU WH,et al.Evaluation methods of in vitro release rate of peptide microsphere injections:a review[J].Chin J New Drugs,2017,26(24):2918
[5] HU L,ZHANG H,SONG W.An overview of preparation and evaluation sustained-release injectable microspheres[J].Microencapsul,2013,30(4):369
[6] MULLARD A.2012 FDA drug approvals[J].Nat Rev Drug Discov,2013,12(2):87
[7] 李想,孙考祥,李又欣.长效微球制剂产业化研究进展[J].中国药学杂志,2019,54(21):1729 LI X,SUN KX,LI YX.Progress in the Industrialization of Sustained-release Microsphere[J]Chin Pharm J,2019,54(21):1729
[8] WAN F,YANG MS.Design of PLGA-based depot delivery systemsfor biopharmaceuticals prepared by spray drying[J].Int JPharm,2016,498(1-2):82
[9] QI F,WU J,YANG TY,et al.Mechanistic studies for monodisperse exenatide-loaded PLGA microspheres prepared by different methods based on SPG membrane emulsification[J].Acta Biomater,2014,10(10):4247
[10] JAIN RA.The manufacturing techniques of various drug loaded biodegradable poly(lactide-co-glycolide) (PLGA) devices[J].Biomaterials,2000,21(23):2475
[11] 郭宁子,辛中帅,孙悦.激光散射法测定注射用醋酸亮丙瑞林微球粒径及其分布[J].中国新药杂志,2017,26(8):886 GUO NZ,XIN ZS,SUN Y,Determination of size and size distribution of leuprorelin acetatemicrospheres for injection using laser diffraction method[J].Chin J New Drugs,2017,26(8):886
[12] 彭芳,周凤梅,刘万卉.注射用缓释微球的体外释放度研究状[J].齐鲁药事,2011,30(5):285 PENG F,ZHOU FM,LIU WH.Study on in vitro release of sustained-release microspheres for injection[J].Qilu Pharm Aff,2011,30(5):285
[13] GITE S,CHOGALE M,PATRAVALE V.Development and validation of a discriminating dissolution method for atorvastatin delayed-release nanoparticles using a flow through cell:a comparative study using USP apparatus 4 and 1[J].Dissol Technol,2016,23(2):14
[14] 李辉,赵悦清,蒋妮谚,等.基于流通池装置的新溶出方法用于尼莫地平片的一致性评价[J].中国药科大学学报,2018,49(3):301 LI H,ZHAO YQ,JIANG NY.A new method based on flow-through cell apparatus to evaluate dissolution consistency of nimodipine tablets[J].J China Pharm Univ,2018,49(3):301
[15] OKADA H.One-and three-month release injectable microspheres of the LH-RH superagonistleuprorelin acetate[J].Adv Drug Del Rev,1997,28(1):43
[16] ANDERSON JM,SHIVER MS.Biodegradation and biocompatibilityof PLA and PLGA microsphere[J].Adv Drug Deliv Rev,1997, 28(1):5
[17] LUCKE A,KIERMAIER J,GPFERICH A.Peptide acylationbypoly(alpha-hydroxy esters)[J].Pharm Res,2002,19(2):175
[18] 张瑞卿,夏云,刘婧,等.醋酸亮丙瑞林原位注射制剂的制备及其体内外释放性能的研究[J].中国医院药学杂志,2019,39(7):691 ZHANG RQ,XIA Y,LIU J,et al.Preparation of leuprolide acetate in situ injection and its in vitro and in vivo release properties[J].Chin Hosp Pharm,2019,39(7):691

欢迎阅读《药物分析杂志》!您是该文第 68位读者!

药物分析杂志 © 2009
地址:北京天坛西里2号 邮政编码:100050; 电子邮件:ywfx@nicpbp.org.cn

本系统由北京博思汇文数字科技有限公司设计开发 技术服务电话:400-921-9838