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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@nifdc.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
 

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火焰原子吸收光谱法测定药用玻璃的内表面耐水侵蚀性

Determination of hydrolytic resistance of the interior surface of pharmaceutical glass containers by flame atomic absorption spectrometry

作者: 王蓉佳, 蔡荣 
作者(英文):WANG Rong-jia, CAI Rong
分类号:
出版年·卷·期(页码):2013,33 (12):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:建立用火焰原子吸收分光光度法测定药用玻璃内表面耐水侵蚀性的方法。方法:加水至玻璃容器满口容量90%,121 ℃保持60 min,用火焰原子吸收分光光度法测定浸提液中钠、钙含量。结果:钠、钙线性范围为0.5~5.0 μg·mL-1(钠:r=0.9999,钙:r=0.9992),检测限分别为0.07、0.1 μg·mL-1,定量限分别为0.2、0.3 μg·mL-1,特征浓度分别为0.04、0.09 μg·mL-1,平均回收率(n=9)分别为102.0%、101.7%。结论:该方法快速、准确、灵敏度高,适于药用玻璃内表面耐水侵蚀性的测定。

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

Objective: To establish a flame atomic absorption spectrometry method for the determination of hydrolytic resistance of the interior surface of pharmaceutical glass containers. Methods: The glass containers were filled with water to 90% of the brimful capacity and maintained at 121 ℃ for 60 min.The sodium and calcium contents of the extraction solutions were determined by flame atomic absorption spectrometry. Results: The linear ranges of sodium and calcium were 0.5-5.0 μg·mL-1,(sodium:r=0.9999,calcium:r=0.9992),the detection limits were 0.07 μg·mL-1 and 0.1 μg·mL-1,the determination limits were 0.2 μg·mL-1 and 0.3 μg·mL-1,the characteristic concentrations were 0.04 μg·mL-1 and 0.09 μg·mL-1,and the mean recoveries were 102.0% and 101.7% (n=9). Conclusion: The method is quick,accurate and highly sensitive.It can be used for the determination of hydrolytic resistance of the interior surface of medicinal glass containers.

-----参考文献:---------------------------------------------------------------------------------------
1 LI Yong-an(李永安), CAI Hong(蔡弘), JI Wei(纪炜), et al.Practical Handbook of Pharmaceutical Packaging(药品包装实用手册)[M].Beijing(北京):Chemical Industry Press(化学工业出版社), 2003.36
2 Dean DA, Evans ER, Hall IH.Pharmaceutical Packaging Technology(药品包装技术)[M].Beijing(北京):Chemical Industry Press(化学工业出版社), 2006.196
3 USP 36[S].2012.https://www.usp-mc.org/sites/default/files/documents/General Chapter PDFS/C660%20USP36.pdf
4 EP7.0[S].2011.363
5 YBB00242003.Tests and classification for 121℃ hydrolytic resistance of interior surfaces(121℃内表面耐水性测定法和分级)[S].2003.1
6 YBB00302002.Injection vials made of low borosilicate glass tubing(低硼硅玻璃管制注射剂瓶)[S].2002.1
7 YBB00322003.Injection vials made of moulded low borosilicate glass tubing (低硼硅玻璃模制注射剂瓶)[S].2003.1
8 ISO4802-2:2010.Glassware-hydrolytic resistance of the interior surfaces of glass containers-Part 2:determination by flame spectrometry and classification(玻璃制品-玻璃容器内表面耐水侵蚀性能-第2部分:用火焰光谱法测定和分级)[S].2010.1
9 QIN Lü(秦旅).Improved method of the determination of calcium in water(原子吸收光谱法测定水中钙的实验改进)[J].Res Explorat Lab(实验室研究与探索), 1997, 6:76
10 HUANG Hui-min(黄慧敏).Flame atomic absorption spectrophotometric determination of potassium and natrium in environmental water(火焰原子吸收分光光度法测定环境水样中钾和钠)[J].Fujian Anal Test(福建分析测试), 2007, 16(2):115
11 GB/T 1347-2008.Methods for chemical analysis of soda-lime-silica glass(钠钙硅玻璃化学分析方法)[S].2008.1
12 NIU Yu-hang(牛玉行).Some ideas on deterioration of wetting quality of glass surface by water(水在玻璃表面的润湿被破坏的一些看法)[J].Glass Enamel(玻璃与搪瓷), 2003, 31(2):26
13 TIAN Ying-liang(田英良), DENG Yong(邓勇), GUO Xian-long(郭现龙), et al.Research on the effect of chemical composition on water resistance of iron titanium coloured medicinal glass(化学成分对铁钛着色医药玻璃耐水性能的影响研究)[J].Glass Enamel(玻璃与搪瓷), 2011, 39(4):1

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