| [1] |
Jin GY,Wang CM,Mo QP.Simultaneous determination of 5 kinds of antioxygens in drug plastic packaging materials by HPLC[J].Chin Med Pharm(中国医药科学),2018,8(17):62-65.
|
| [2] |
Zhang WH.Study on compatibility of new type compound amino acids injection and packaging materials(新型复方氨基酸注射液的内包装材料相容性研究)[D].Beijing University of Chemical Technology,2016.
|
| [3] |
Zhang Y,Yuan Q,Jiang M,et al.Research progress in toxicity and detection methods of phthalic acid esters[J].Environ Chem(环境化学),2019,38(5):1035-1046.
|
| [4] |
U.S.Food and Drug Administration.Guidance for Industry Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products[EB/OL].[2012-12-21] .https://www.fda.gov/media/83029/download.
|
| [5] |
China Food and Drug Administration.YBB00142002 Guideline of Evaluating Compatibility between Pharmaceutical Packaging and Pharmaceuticals(药品包装材料与药物相容性试验指导原则)[S].2002:72-74.
|
| [6] |
China Food and Drug Administration.Regulations on immediate package materials an containers of drugs.(直接接触药品的包装材料和容器管理办法)[EB/OL].[2004-07-20] .http://www.sda.gov.cn/WS01/CL0053/24499.html.
|
| [7] |
China Food and Drug Administraion.Technical Guidelines for the Research on the Compatibility of Chemical Medicine Injection and Glass Packing Container(化学药品注射剂与药用玻璃包装容器相容性研究技术指导原则)[S].2015.
|
| [8] |
Chinese Pharmacopoeia Commission.Chinese Phamacopeia:part 4(中华人民共和国药典:四部)[S].Beijing:China Medical Science Press,2015:413-416.
|
| [9] |
U.S.Food and Drug Administration.Guidance for industry.container closure systems for packaging human drugs and biologics[EB/OL].[1999-05-01] .http:/www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/ UCM070551.pdf.
|
| [10] |
United States Pharmacopeia Convention.United States Pharmacopoeia 40[S].United States Pharmacopeia Convention,2017:541-554.
|
| [11] |
European Medicines Agency.Guideline on plastic immediate packaging materials[EB/OL].[2005-05-19] .http://www.ema.europa.eu/docs/en_GB/document_library/Scientific _ guideline/2009/09/WC500003448.pdf.
|
| [12] |
European Directorate for the Quality of Medicines.European Pharmacopoeia 9.0[S].European Directorate for the Quality of Medicines & Health Care,2017:390-430.
|
| [13] |
Pharmaceuticals and Medical Devices Agency.The Japanese Pharmacopoeia 17[S].Ministry of Health,Labour and Welfare,2016:166-179.
|
| [14] |
Jenke D,Odufu A,Poss M.The effect of solvent polarity on the accumulation of leachables from pharmaceutical product containers[J].Eur J Pharm Sci,2006,27(2/3):133-142.
|
| [15] |
Jenke DR,Story J,Lalani R.Extractables/leachables from plastic tubing used in product manufacturing[J].Int J Pharm,2006,315(1/2):75-92.
|
| [16] |
Jenke DR,Stults CL,Paskiet DM,et al.Materials in manufacturing and packaging systems as sources of elemental impurities in packaged drug products:a literature review[J].PDA J Pharm Sci Technol,2015,69(1):1-48.
|
| [17] |
Green S,Bai S,Cheatham M,et al.Determination of antioxidants in polyolefins using total dissolution methodology followed by RPLC[J].J Sep Sci,2010,33(22):3455-3462.
|
| [18] |
Stults CL,Ansell JM,Shaw AJ,et al.Evaluation of extractables in processed and unprocessed polymer materials used for pharmaceutical applications[J].AAPS Pharmscitech,2015,16(1):150-164.
|
| [19] |
Gao Y,Allison N.Extractables and leachables issues with the application of single use technology in the biopharmaceutical industry[J].J Chem Technol Biot,2016,91(2):289-295.
|
| [20] |
Lin HJ,Wu Y,Zhang YL.Extraction and determination of DBP degradated from Irgafos 168 in three-layer co-extrusion film for infusion bag[J].Chin J Pharm(中国医药工业杂志),2014,45(7):677-680.
|
| [21] |
Li Y,Sun HM,Zhang X.Determination of antioxidants in plastic infusion packaging materials and containers and the migration to injections[J].Chin Pharm J(中国药学杂志),2016,51(19):1699-1705.
|
| [22] |
Wang F, Li Y, Sun HM. Migration studies on the additives of polypropylene infusion bottle[J].Chin J Pharm Anal(药物分析杂志),2012,32(3):414-415.
|
| [23] |
Liu QP.Research of ambroxol hydrochloride glucose infusion packed by multi-layer co-extruded injection film(多层共挤膜输液袋盐酸氨溴索葡萄糖注射液的研究)[D].Tianjin University,2016.
|
| [24] |
Zhao X, He X, Sun HM. Study on the migration of residual styrene to injection from three-layer co-extrusion bags[J].Chin Pharm Aff(中国药事),2014,28(8):835-838.
|
| [25] |
Liu XH,Yin H,Yan F,et al.Compatibility of pre-filled syringes with pharmaceutical products[J].J China Pharm Univ(中国药科大学),2016,47(3):275-281.
|
| [26] |
Bao Y,Geng Z,Yuan WX,et al.Adsorption of urapidil by urapidil injection and urapidil hydrochloride injection packaging materials[J].Pharm J Chin PLA(解放军药学学报),2017,33(5):448-450.
|
百度学术
下载:
