硅酸盐通报, 2022, 41 (11): 3960, 网络出版: 2022-12-26  

中硼硅管制瓶内表面离子迁移特性研究

Migration Characteristics on Inner Surface of Neutral Borosilicate Glass Tube Vials
作者单位
1 北京工业大学材料与制造学部,北京 100124
2 江苏潮华玻璃制品有限公司,镇江 212321
3 沧州四星玻璃股份有限公司,沧州 061739
摘要
本文以中硼硅管制瓶为研究对象,ICPAES为研究手段,通过改变药液浓度、药液pH值、药液储存时间、玻璃瓶规格来探究玻璃瓶内表面Al3+、B3+、Ca2+、K+、Na+、Si4+的迁移规律,并通过SEM观察玻璃瓶内表面受侵蚀情况。结果显示:随储存时间延长,玻璃瓶内表面受侵蚀程度增大,在储存28 d时,K+和Na+的迁移浓度下降,Al3+、B3+、Ca2+、Si4+迁移浓度上升,出现脱片现象;玻璃瓶规格越小,离子的迁移浓度越大,玻璃瓶内表面受侵蚀程度越大;药液浓度越低,离子的迁移浓度越小,玻璃瓶内表面受侵蚀程度越小;酸性和碱性药液都会增大玻璃瓶内表面受侵蚀程度,且碱性药液对玻璃瓶内表面侵蚀更大。
Abstract
In this paper, neutral borosilicate glass tube vials were taken as research object, and ICPAES was used as research method. By changing liquid medicine concentration, liquid medicine pH value, liquid medicine storage time, glass bottle specification, the migration law of Al3+, B3+, Ca2+, K+, Na+, Si4+ on the inner surface of glass bottle were explored, and the inner surface erosion of glass bottle was observed by SEM. The results show that with the prolongation of storage time, the erosion degree of the inner surface of glass bottle increases. When storage time is 28 d, the migration concentration of K+ and Na+ decreases, the migration concentration of Al3+, B3+, Ca2+, Si4+ increases, and the peeling phenomenon occurs. The smaller the glass bottle specification is, the greater the migration concentration of ions and the erosion degree of the inner surface of glass bottle are. The smaller the liquid medicine concentration is, the smaller the concentration of ions and the erosion degree of the inner surface of glass bottle are. Both acidic and alkaline solution make the erosion degree of the inner surface of glass bottle increase, and alkaline liquid on the inner surface of glass bottle erosion is greater.
参考文献

[1] 郭 勇.全氧燃烧技术在药用玻璃领域的应用[J].玻璃与搪瓷,2017,45(4):4347.

[2] 何子骞.药品包装材料对药品质量的影响[J].生物化工,2020,6(2):112114.

[3] 李道国.国际中性玻璃在药品包装领域的应用及前景[J].机电信息,2004(21):1921.

[4] 李 烨,张毅兰.通过加速试验考察不同介质对药用玻璃容器形成脱片的影响[J].中国医药工业杂志,2015,46(3):293298.

[5] 孙会敏,李 樾,赵 霞,等.注射剂与药用玻璃包装容器相容性研究试验方法指南[J].中国药事,2018,32(9):11891196.

[6] OGAWA T, MIYAJIMA M, NISHIMOTO N, et al. Comparisons of aluminum and silica elution from various glass vials[J]. Chemical & Pharmaceutical Bulletin, 2016, 64(2): 150160.

[7] IACOCCA R G, TOLTL N, ALLGEIER M, et al. Factors affecting the chemical durability of glass used in the pharmaceutical industry[J]. AAPS PharmSciTech, 2010, 11(3): 13401349.

[8] BROWN J B, WATTS A S. Some studies on reactions between glasses and phosphate solutions[J]. Journal of the American Ceramic Society, 1937, 20(1/2/3/4/5/6/7/8/9/10/11/12): 245250.

[9] BACON F R, RAGGON F C. Promotion of attack on glass and silica by citrate and other anions in neutral solution[J]. Journal of the American Ceramic Society, 1959, 42(4): 199205.

[10] ERNSBERGER F M. Attack of glass by chelating agents[J]. Journal of the American Ceramic Society, 1959, 42(8): 373375.

[11] 应志洪,蒋红梅,姜小林,等.注射用泮托拉唑钠与玻璃容器的相容性研究[J].药物分析杂志,2017,37(11):20942100.

[12] 颜 敏,刘园园,贺瑞玲,等.ICPMS法测定药用玻璃容器中13种金属元素的浸出量[J].药物分析杂志,2016,36(1):133137.

[13] 刘兴兰,张向崇,兰 俊.药用玻璃包装容器相容性试验中硅、硼迁移量测定的研究[J].药物分析杂志,2015,35(11):20242027.

[14] HLADIK B, BUSCKE F, FROST R, et al. Comparative leachable study of glass vials to demonstrate the impact of low fill volume[J]. PDA Journal of Pharmaceutical Science and Technology, 2019, 73(4): 345355.

[15] 王 帆,田英良,袁春梅.药用玻璃容器内表面药液吸附研究综述[J].广州化工,2021,49(1):1214+65.

[16] 冯明良.玻璃表面之组成、结构与特性[J].玻璃,1986,13(2):3942.

[17] TOURNOUR C C, SHELBY J E. Molecular oxygen diffusion in vitreous silica[J]. Physics and Chemistry of Glasses, 2005, 46(6): 559563.

[18] VARSHNEYA A K, MAURO J C. Fundamentals of inorganic glass[M]. Amsterdam: Elsevier, 2019: 631685.

[19] ZENG K, GAO Z M, TREHY M, et al. Dissolution test of tacrolimus capsule: effects of filtration and glass adsorption[J]. AAPS PharmSciTech, 2018, 19(2): 961964.

[20] 田英良,孙诗兵.新编玻璃工艺学[M].北京:中国轻工业出版社,2009.

田英良, 温玉琳, 王帆, 王华, 王焕一, 赵志永, 孙诗兵. 中硼硅管制瓶内表面离子迁移特性研究[J]. 硅酸盐通报, 2022, 41(11): 3960. TIAN Yingliang, WEN Yulin, WANG Fan, WANG Hua, WANG Huanyi, ZHAO Zhiyong, SUN Shibing. Migration Characteristics on Inner Surface of Neutral Borosilicate Glass Tube Vials[J]. Bulletin of the Chinese Ceramic Society, 2022, 41(11): 3960.

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