注射用血栓通(冻干)与氯化丁基胶塞相容性研究中抗氧剂的含量测定  

Determination of Antioxidants in the Study of Compatibility Between Xueshuantong for Injection(Lyophilized)and Chlorinated Butyl Rubber Plugs

作　　者：覃济桓 张兆佳 王海燕 

机构地区：[1]广西梧州制药(集团)股份有限公司,广西梧州543000 [2]广西三七综合利用技术重点实验室,广西梧州543000

出　　处：《大众科技》2020年第6期32-34,共3页Popular Science & Technology

摘　　要：目的:建立气相色谱法(GC),考察注射用冷冻干燥无菌粉末用覆聚四氟乙烯/乙烯共聚物膜氯化丁基橡胶塞中抗氧剂2,6-二叔丁基-4-甲基苯酚(抗氧剂264)在药品中的迁移情况。方法:采用HP-5色谱柱(30 m×0.32 mm,0.25μm);进样口:250℃;FID检测器温度:300℃;分流比10∶1;柱温程序:起始温度120℃,保持2 min,以6℃·min-1速率升至200℃保持5 min,再以20℃·min-1速率升温至230℃,保持10 min;载气:氮气,流速1.0 mL·min-1;进样量:1μL。结果:抗氧剂264在浓度5.13μg·mL-1~205.29μg·mL-1范围内线性良好(相关系数R≥0.9990);抗氧剂264在橡胶塞中的提取重复性范围是99.9μg·g-1~107.1μg·g-1(n=6,RSD=2.4%);抗氧剂264提取回收率范围是91.5%~102.5%(n=9,RSD=3.5%)。结论:本方法灵敏、准确、可靠,可用于药用氯化丁基橡胶塞中抗氧剂264的提取和迁移研究。Objective:To establish a gas chromatography(GC)method for investigating the migration of antioxidant 2,6-di-tert-butyl-4-methylphenol(antioxidant 264)in the chlorinated butyl rubber plug coated with polytetrafluoroethylene/ethylene copolymer film for freeze-dried sterile powder for injection.Methods:HP-5 chromatography column(30m×0.32mm,0.25μm)was used;sample inlet:250℃;FID detector temperature:300℃;split ratio 10:1;column temperature program:initial temperature 120℃,holding for 2min,rising to 200℃at a rate of 6℃·min-1,holding for 5 min,then increase the temperature to 230℃at a rate of 20℃·min-1,holding for 10 minutes;carrier gas:nitrogen,flow rate 1.0 mL min-1;sample volume:1μL.Results:the linearity of antioxidant 264 in the range of 5.13μg·mL-1 to 205.29μg·mL-1 was good(R≥0.9990);the repeatability of antioxidant 264 in the rubber plugs was 99.9μg·g-1~107.1μg·g-1(n=6,RSD=2.4%);the extraction recovery rate of antioxidant 264 was 91.5%~102.5%(n=9,RSD=3.5%).Conclusion:This method is sensitive,accurate and reliable,and can be used for the extraction and migration study of antioxidant 264 in medicinal chlorobutyl rubber plugs.

关 键 词：气相色谱法 抗氧剂264 注射用血栓通 

分 类 号：R927.1[医药卫生—药学]