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一次性輸液器中ATBC溶出量的測(cè)定方法

Measurement method of ATBC migration in disposable infusion set

作者: 董放 
單位:國(guó)家食品藥品監(jiān)督管理總局藥品評(píng)價(jià)中心 (北京100045)
關(guān)鍵詞: 一次性輸液器;氣相色譜法;乙酰檸檬酸三丁酯;溶出量  ;增塑劑 
分類號(hào):R318;TQ414
出版年·卷·期(頁(yè)碼):2017·36·1(70-76)
摘要:

目的 建立測(cè)定一次性輸液器在使用過(guò)程中其增塑劑乙酰檸檬酸三丁酯(acetyl tributyl citrate,  ATBC)溶出量的氣相色譜(gas chromatography, GC)方法,并對(duì)其臨床使用過(guò)程中的安全性進(jìn)行研究和驗(yàn)證。方法 分別利用非脂溶性和脂溶性溶液模擬臨床輸液環(huán)境,探討一次性輸液器中ATBC溶出量測(cè)定方法的準(zhǔn)確性和有效性。非脂溶性溶液,色譜柱:島津Rtx-624毛細(xì)管柱(30m×0.53mm, 3μm);脂溶性溶液,色譜柱:DB-624毛細(xì)管柱(30m×0.45mm, 3μm);其他條件二者均相同,氫氣:40mL/min;空氣:400mL/min;氮?dú)猓?5mL/min作為流動(dòng)相;內(nèi)標(biāo)物:十六烷;柱溫:240℃;進(jìn)樣量:1μL。結(jié)果 非脂溶性溶液中,ATBC在10~200μg/mL內(nèi)呈良好線性關(guān)系,相關(guān)系數(shù)為0.9999,平均回收率為97.44%(RSD2.4%);脂溶性溶液中,ATBC在10~200μg/mL內(nèi)呈良好線性關(guān)系,相關(guān)系數(shù)為0.9999,平均回收率為92.02%(RSD7.9%)。結(jié)論 利用氣相色譜法測(cè)定ATBC溶出量,精確度高、回收率好。該方法可用于ATBC含量分析,為以ATBC作為塑化劑的一次性輸液器質(zhì)量控制及進(jìn)一步研究提供參考。

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.

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