新型给药系统的辐射灭菌
Radiation sterilization of new drug delivery systems.
作者信息
Abuhanoğlu Gürhan, Ozer A Yekta
机构信息
Department of Radiopharmacy, Faculty of Pharmacy, Hacettepe University Sıhhiye, Ankara Turkey.
出版信息
Interv Med Appl Sci. 2014 Jun;6(2):51-60. doi: 10.1556/IMAS.6.2014.2.1. Epub 2014 Jun 4.
Abstract
Radiation sterilization has now become a commonly used method for sterilization of several active ingredients in drugs or drug delivery systems containing these substances. In this context, many applications have been performed on the human products that are required to be sterile, as well as on pharmaceutical products prepared to be developed. The new drug delivery systems designed to deliver the medication to the target tissue or organ, such as microspheres, nanospheres, microemulsion, and liposomal systems, have been sterilized by gamma (γ) and beta (β) rays, and more recently, by e-beam sterilization. In this review, the sterilization of new drug delivery systems was discussed other than conventional drug delivery systems by γ irradiation.
摘要
辐射灭菌现已成为对药物中几种活性成分或含有这些物质的药物递送系统进行灭菌的常用方法。在此背景下，已对要求无菌的人类产品以及准备开发的药品进行了许多应用。旨在将药物递送至靶组织或器官的新型药物递送系统，如微球、纳米球、微乳和脂质体系统，已通过伽马（γ）射线和贝塔（β）射线进行灭菌，最近也通过电子束灭菌。在本综述中，除了传统药物递送系统外，还讨论了通过γ辐照对新型药物递送系统进行的灭菌。
相似文献
1
Radiation sterilization of new drug delivery systems.新型给药系统的辐射灭菌
Interv Med Appl Sci. 2014 Jun;6(2):51-60. doi: 10.1556/IMAS.6.2014.2.1. Epub 2014 Jun 4.
2
Planning Implications Related to Sterilization-Sensitive Science Investigations Associated with Mars Sample Return (MSR).与火星样本返回（MSR）相关的对灭菌敏感的科学研究的规划意义。
Astrobiology. 2022 Jun;22(S1):S112-S164. doi: 10.1089/AST.2021.0113. Epub 2022 May 19.
3
Gamma sterilization of pharmaceuticals--a review of the irradiation of excipients, active pharmaceutical ingredients, and final drug product formulations.药品的伽马射线灭菌——辅料、活性药物成分及最终药品制剂辐照的综述
PDA J Pharm Sci Technol. 2014 Mar-Apr;68(2):113-37. doi: 10.5731/pdajpst.2014.00955.
4
Nano drug delivery systems and gamma radiation sterilization.纳米药物传递系统与伽马射线灭菌。
Pharm Dev Technol. 2017 Sep;22(6):775-784. doi: 10.3109/10837450.2016.1163393. Epub 2016 Apr 6.
5
Soft-tissue allografts terminally sterilized with an electron beam are biomechanically equivalent to aseptic, nonsterilized tendons.采用电子束末端灭菌的软组织同种异体移植物在生物力学上等同于无菌、未灭菌的肌腱。
J Bone Joint Surg Am. 2014 Aug 20;96(16):1321-6. doi: 10.2106/JBJS.L.00841.
6
Sterilization process of polyester based anticancer-drug delivery systems.聚酯类抗癌药物输送系统的灭菌过程。
Int J Pharm. 2020 Sep 25;587:119663. doi: 10.1016/j.ijpharm.2020.119663. Epub 2020 Jul 20.
7
Preservation of biological activity of glial cell line-derived neurotrophic factor (GDNF) after microencapsulation and sterilization by gamma irradiation.微囊化并经γ射线辐射灭菌后胶质细胞源性神经营养因子（GDNF）的生物活性的保持。
Int J Pharm. 2012 Oct 15;436(1-2):545-54. doi: 10.1016/j.ijpharm.2012.07.019. Epub 2012 Jul 22.
8
Sterilization and polyethylene wear: clinical studies to support laboratory data.灭菌与聚乙烯磨损：支持实验室数据的临床研究
J Bone Joint Surg Am. 2004 May;86(5):1017-22.
9
The effect of radiation on a variety of pharmaceuticals and materials containing polymers.辐射对多种含聚合物的药物和材料的影响。
PDA J Pharm Sci Technol. 2012 Mar-Apr;66(2):184-99. doi: 10.5731/pdajpst.2012.00774.
10
Alternative methods of terminal sterilization for biologically active macromolecules.生物活性大分子的终端灭菌替代方法。
Curr Opin Drug Discov Devel. 2001 Nov;4(6):760-3.
引用本文的文献
1
Degradable Hydrogel Microspheres for Drug Delivery: In Vitro Performance and Influence of E-Beam Sterilization.用于药物递送的可降解水凝胶微球：体外性能及电子束灭菌的影响
AAPS PharmSciTech. 2025 Jun 4;26(5):162. doi: 10.1208/s12249-025-03144-1.
2
Pharmacological Innovations in Space: Challenges and Future Perspectives.太空药物创新：挑战与未来展望。
Pharm Res. 2024 Nov;41(11):2095-2120. doi: 10.1007/s11095-024-03788-x. Epub 2024 Nov 12.
3
Chemistry and Art of Developing Lipid Nanoparticles for Biologics Delivery: Focus on Development and Scale-Up.用于生物制品递送的脂质纳米颗粒的化学与研发工艺：聚焦于研发与放大生产
Pharmaceutics. 2024 Jan 19;16(1):131. doi: 10.3390/pharmaceutics16010131.
4
Strategies for overcoming protein and peptide instability in biodegradable drug delivery systems.克服可生物降解药物递送系统中蛋白质和肽不稳定性的策略。
Adv Drug Deliv Rev. 2023 Aug;199:114904. doi: 10.1016/j.addr.2023.114904. Epub 2023 May 30.
5
Astropharmacy: Roles of Pharmacist in Space.太空药学：药剂师在太空中的角色。
Innov Pharm. 2022 Dec 12;13(3). doi: 10.24926/iip.v13i3.4956. eCollection 2022.
6
Protection against virulent spp. by gamma-irradiated in BALB/c mice model.在BALB/c小鼠模型中，γ射线辐照对致病性[具体菌种名称未给出]的防护作用。
Clin Exp Vaccine Res. 2022 Jan;11(1):53-62. doi: 10.7774/cevr.2022.11.1.53. Epub 2022 Jan 31.
7
Challenges in delivering therapeutic peptides and proteins: A silk-based solution.递送治疗性肽和蛋白质的挑战：基于丝的解决方案。
J Control Release. 2022 May;345:176-189. doi: 10.1016/j.jconrel.2022.02.011. Epub 2022 Feb 11.
8
Stability of Antimicrobial Drug Molecules in Different Gravitational and Radiation Conditions in View of Applications during Outer Space Missions.考虑到在外层空间任务中的应用，不同引力和辐射条件下抗菌药物分子的稳定性。
Molecules. 2021 Apr 12;26(8):2221. doi: 10.3390/molecules26082221.
9
Role of Commensal Microbes in the γ-Ray Irradiation-Induced Physiological Changes in .共生微生物在γ射线照射诱导的[具体对象]生理变化中的作用 。（原文此处不完整，缺少具体受照射对象）
Microorganisms. 2020 Dec 24;9(1):31. doi: 10.3390/microorganisms9010031.
10
Stability and anti-proliferative properties of biologically active compounds extracted from Cistus L. after sterilization treatments.经灭菌处理后，从石蚕属植物中提取的具有生物活性的化合物的稳定性和抗增殖特性。
Sci Rep. 2020 Apr 16;10(1):6521. doi: 10.1038/s41598-020-63444-3.
本文引用的文献
1
Gamma-irradiated liposome/noisome and lipogelosome/niogelosome formulations for the treatment of rheumatoid arthritis.用于治疗类风湿性关节炎的γ射线辐照脂质体/纳米泡囊以及脂质凝胶体/纳米凝胶体制剂
Interv Med Appl Sci. 2013 Jun;5(2):60-9. doi: 10.1556/IMAS.5.2013.2.2. Epub 2013 Jul 4.
2
Impact of ionizing radiation on physicochemical and biological properties of an amphiphilic macromolecule.电离辐射对两亲性大分子物理化学和生物学性质的影响。
Polym Degrad Stab. 2012 Sep 1;97(9):1686-1689. doi: 10.1016/j.polymdegradstab.2012.06.017. Epub 2012 Jun 27.
3
Niosomes as a potential drug delivery system for increasing the efficacy and safety of nystatin.作为一种潜在的药物传递系统，尼索米星可以提高制霉菌素的疗效和安全性。
Drug Dev Ind Pharm. 2011 Dec;37(12):1491-508. doi: 10.3109/03639045.2011.587431. Epub 2011 Jun 27.
4
Gamma irradiated micro system for long-term parenteral contraception: An alternative to synthetic polymers.用于长期胃肠外避孕的γ射线辐照微系统：合成聚合物的替代品
Eur J Pharm Sci. 2008 Nov 15;35(4):307-17. doi: 10.1016/j.ejps.2008.07.009. Epub 2008 Aug 8.
5
Use of nanoparticles for cerebral cancer.纳米颗粒在脑癌治疗中的应用。
Tumori. 2008 Mar-Apr;94(2):271-7. doi: 10.1177/030089160809400220.
6
Radiation sterilisation of doxorubicin bound to poly(butyl cyanoacrylate) nanoparticles.与聚氰基丙烯酸丁酯纳米颗粒结合的阿霉素的辐射灭菌
Int J Pharm. 2008 May 22;356(1-2):325-32. doi: 10.1016/j.ijpharm.2008.01.010. Epub 2008 Jan 16.
7
Cryo-irradiation as a terminal method for the sterilization of drug aqueous solutions.冷冻辐照作为药物水溶液灭菌的最终方法。
Eur J Pharm Biopharm. 2008 May;69(1):358-63. doi: 10.1016/j.ejpb.2007.11.007. Epub 2007 Nov 23.
8
Dirhenium decacarbonyl-loaded PLLA nanoparticles: influence of neutron irradiation and preliminary in vivo administration by the TMT technique.负载二铼十羰基的聚乳酸纳米颗粒：中子辐照的影响及TMT技术的体内初步给药
Int J Pharm. 2008 Feb 4;348(1-2):125-36. doi: 10.1016/j.ijpharm.2007.07.010. Epub 2007 Jul 14.
9
Lyophilisation and sterilisation of liposomal vaccines to produce stable and sterile products.冻干和脂质体疫苗的灭菌以生产稳定且无菌的产品。
Methods. 2006 Sep;40(1):30-8. doi: 10.1016/j.ymeth.2006.05.025.
10
Sterilization of gentamicin containing collagen/PLGA microparticle composites.含庆大霉素的胶原蛋白/聚乳酸-羟基乙酸共聚物微粒复合材料的灭菌
Eur J Pharm Biopharm. 2006 Jun;63(2):176-87. doi: 10.1016/j.ejpb.2005.11.007. Epub 2006 Feb 23.
Zotero 插件