设为首页 |  加入收藏
首页首页 期刊简介 消息通知 编委会 电子期刊 投稿须知 广告合作 联系我们
一次性输液器中ATBC溶出量的测定方法

Measurement method of ATBC migration in disposable infusion set

作者: 董放 
单位:国家食品药品监督管理总局药品评价中心 (北京100045)
关键词: 一次性输液器;气相色谱法;乙酰柠檬酸三丁酯;溶出量  ;增塑剂 
分类号:R318;TQ414
出版年·卷·期(页码):2017·36·1(70-76)
摘要:

目的 建立测定一次性输液器在使用过程中其增塑剂乙酰柠檬酸三丁酯(acetyl tributyl citrate,  ATBC)溶出量的气相色谱(gas chromatography, GC)方法,并对其临床使用过程中的安全性进行研究和验证。方法 分别利用非脂溶性和脂溶性溶液模拟临床输液环境,探讨一次性输液器中ATBC溶出量测定方法的准确性和有效性。非脂溶性溶液,色谱柱:岛津Rtx-624毛细管柱(30m×0.53mm, 3μm);脂溶性溶液,色谱柱:DB-624毛细管柱(30m×0.45mm, 3μm);其他条件二者均相同,氢气:40mL/min;空气:400mL/min;氮气:15mL/min作为流动相;内标物:十六烷;柱温:240℃;进样量:1μL。结果 非脂溶性溶液中,ATBC在10~200μg/mL内呈良好线性关系,相关系数为0.9999,平均回收率为97.44%(RSD2.4%);脂溶性溶液中,ATBC在10~200μg/mL内呈良好线性关系,相关系数为0.9999,平均回收率为92.02%(RSD7.9%)。结论 利用气相色谱法测定ATBC溶出量,精确度高、回收率好。该方法可用于ATBC含量分析,为以ATBC作为塑化剂的一次性输液器质量控制及进一步研究提供参考。

Objective To establish GC method for measuring the migration of acetyl tributyl citrate (ATBC) as disposable infusion set being used and to study and validate the safety of the clinical use. Methods Respectively, we simulated clinical infusion environment with non-fat-soluble and fat-soluble solutions to investigate the accuracy and validity of the measurement for the migration of ATBC by GC method. In non-fat-soluble solution, Column: Shimadzu Rtx-624 capillary column (30m×0.53mm, 3μm);In fat-soluble solution, Column: DB-624 capillary column (30m×0.45mm, 3μm);The following conditions were the same, hydrogen: 40mL/min;air: 400mL/min;nitrogen: 15mL/min as the mobile phase;within standard: hexadecane;column temperature: 240℃;injection volume: 1μL. Results In non-fat-soluble solution, ATBC at 10 to 200μg/mL showed a good linear relationship within a correlation coefficient of 0.9999, the average recovery was 97.44% (RSD 2.4%);In fat-soluble solution, ATBC at 10 to 200μg/mL showed a good linear relationship within a correlation coefficient of 0.9999, the average recovery was 92.02% (RSD 7.9%).Conclusions Measured migration of ATBC by gas GC method has a high accuracy and a good recovery rate. The method can be used for the content analysis of ATBC, which provides a reference for the quality control of infusion device containing ATBC and further research.

参考文献:

服务与反馈:
文章下载】【加入收藏
提示:您还未登录,请登录!点此登录
 
友情链接  
地址:北京安定门外安贞医院内北京生物医学工程编辑部
电话:010-64456508  传真:010-64456661
电子邮箱:llbl910219@126.com