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DEHP和TOTM增塑的PVC一次性輸液器與脂肪乳注射液藥物相容性研究

Drug compatibility between fat emulsion injection and PVC disposable infusion set plasticized with DEHP and TOTM

作者: 魏嫣  黃元禮  王麗  馬立群  艾鳴哲 
單位:國家食品藥品監(jiān)督管理局湖北醫(yī)療器械質(zhì)量監(jiān)督檢驗(yàn)中心(武漢430075)
關(guān)鍵詞: 鄰苯二甲酸二乙基乙酯;偏苯三酸三辛酯;增塑劑;脂肪乳;藥物相容性 
分類號:R318.04
出版年·卷·期(頁碼):2016·35·1(41-45)
摘要:

目的 通過研究含有鄰苯二甲酸二乙基乙酯(diethylhexyl phthalate, DEHP)和偏苯三酸三辛酯(trioctyl trimellitate, TOTM)兩種增塑劑的一次性輸液器與脂肪乳注射液的藥物相容性,考察新型增塑劑TOTM對脂肪乳注射液的安全性。對DEHP和TOTM增塑的PVC輸液器的風(fēng)險評估提出可行性依據(jù)。方法 模擬臨床使用條件,收集不同時間點(diǎn)經(jīng)過輸液器的脂肪乳注射液,采用HPLC進(jìn)行測試,考察兩種輸液器對于脂肪乳注射液中大豆油的吸附性能及增塑劑的遷移情況。建立了同時檢測脂肪乳注射液中DEHP和TOTM的高效液相色譜方法。結(jié)果 脂肪乳中的大豆油在兩種管路中吸附情況不同,兩種輸液器對大豆油均有一定的吸附作用,DEHP為增塑劑的輸液器在模擬使用4h內(nèi)大豆油濃度變化率為87.5%~92.0%。TOTM為增塑劑的輸液器對大豆油吸附隨使用時間的延長吸附漸大,在使用的前2h幾乎無吸附,大豆油濃度相對于零時間的變化率為98.4%~99.6%;在使用2h后開始有明顯吸附,大豆油濃度相對于零時間的變化率達(dá)47.9%~52.0%。增塑劑遷移試驗(yàn)中,在本實(shí)驗(yàn)的檢出限條件下,未檢出DEHP的遷移,TOTM的遷移在脂肪乳流經(jīng)輸液器30~60min過程中有檢出。結(jié)論 本方法考察了TOTM和DEHP為增塑劑的PVC一次性輸液器與脂肪乳注射液的藥物相容性,為風(fēng)險評估提供依據(jù)。

Objective To evaluate the safety of TOTM, this study carried on the research on the drug compatibility between fat emulsion injection and PVC disposable infusion set plasticized with DEHP and TOTM, and provided acceptable support for safety evaluation of PVC infusion apparatus of different plasticizers. Methods After simulating clinical conditions, collecting the fat emulsion injection runs by the PVC disposable infusion set at different time point, and adopting HPLC to test, the adsorption properties of soybean oil and plasticizer migration was inspected between the two infusions. We established a HPLC approach to detect the content of both DEHP and TOTM in the fat emulsion injection. Results The soybean oil in fat emulsion injection was absorbed differently in the two tubes. The rate of change of the soybean oil concentration within 4 h is 87.5% to 92.0% in the infusion which was used DEHP as plasticizer. The absorption of the infusion to soybean oil which was used TOTM as plasticizer increased with the time. Relative to zero time concentration, the rate of change of the soybean oil concentration in the infusion which was used TOTM as plasticizer reached 98.4% to 99.6% in the first two hours, almost no absorption. After two hours, the rate of change of the soybean oil concentration reached 47.9% to 52.0% compared to the concentration of zero time. Obvious absorption of soybean oil began after 2h since TOTM was used. In plasticizer migration test the migration of DEHP was not detected while the migration of TOTM was detected when fat emulsion injection flew through the infusion from 30min to 60min. Conclusions This method evaluates the two plasticizers, TOTM and DEHP, on its drug compatibility of PVC disposable infusion set and fat emulsion injection.

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