Page 99 - 《中国药房》2023年2期

15种细胞毒性抗肿瘤药物在我院PIVAS中的环境残留检测及清

洁方法
Δ

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耿 洲 ，王 洋，屈昱晨，陈 浩，刘文秀，费 雯，潘 杰（苏州大学附属第二医院药学部，江苏 苏州
＊
215006）

中图分类号 R917；R952 文献标志码 A 文章编号 1001-0408（2023）02-0217-06
DOI 10.6039/j.issn.1001-0408.2023.02.17

摘 要 目的 为静脉用药集中调配中心（PIVAS）提供减少环境残留的方法，保障医护人员的职业健康。方法 采用高效液相色
谱-四极杆/静电场轨道阱高分辨质谱技术检测我院PIVAS环境中吉西他滨等15种细胞毒性抗肿瘤药物的残留量，并以残留量为
指标优化清洁流程；采用氮吹法进行酒精挥发试验；采用CCK-8法检测含氯消毒液对细胞毒性抗肿瘤药物毒性的影响。结果 吉
西他滨等15种药物的线性范围为0.5～1 000 ng/mL；日内、日间精密度的RSD均不高于20.00%。我院PIVAS环境中检测到吉西
他滨、异环磷酰胺、环磷酰胺等6种药物，以环磷酰胺的残留量较高。最优清洁程序为清水清洁1次+1 000 mg/L含氯消毒液清洁1
次+75%酒精清洁1次后，用干纱布擦拭。酒精挥发试验结果显示，对照组与75%酒精组各药物的残留量比较，差异无统计学意义
（P＞0.05）。CCK-8实验结果显示，与对照组比较，15种细胞毒性抗肿瘤药物组细胞生存率显著下降（P＜0.01），15种细胞毒性抗
肿瘤药物+含氯消毒液组细胞生存率显著高于15种细胞毒性抗肿瘤药物组（P＜0.01）。结论 成功建立了同时测定PIVAS环境中
吉西他滨等15种细胞毒性抗肿瘤药物残留的方法；最优清洁程序能降低细胞毒性抗肿瘤药物的残留量，含氯消毒液能降低其毒
性，且残留药物不会随酒精挥发而造成操作区域的二次污染。
关键词 静脉用药集中调配中心；高效液相色谱-四极杆/静电场轨道阱高分辨质谱技术；细胞毒性抗肿瘤药物；环境残留检测；环
境残留清洁

Study on environmental residues detection and cleaning method of 15 cytotoxic antineoplastic drugs in
PIVAS of our hospital
GENG Zhou，WANG Yang，QU Yuchen，CHEN Hao，LIU Wenxiu，FEI Wen，PAN Jie（Dept. of Pharmacy， the
Second Affiliated Hospital of Soochow University， Jiangsu Suzhou 215006， China）

ABSTRACT OBJECTIVE To provide a method to reduce environmental residues for pharmacy intravenous admixture service
（PIVAS）， and ensure the occupational health of medical staff. METHODS The residues of 15 cytotoxic antineoplastic drugs such
as gemcitabine were detected by UPLC-Q-Orbitrap-HRMS. The cleaning process was optimized with the residual quantity as the
index. Nitrogen blowing method was used for alcohol volatilization experiment. CCK-8 assay was used to detect the effect of
chlorine-containing disinfectant on the toxicity of cytotoxic antitumor drugs. RESULTS The linear range of 15 cytotoxic
antineoplastic drugs such as gemcitabine were 0.5-1 000 ng/mL. RSDs of intra-day and intra-day precision were no higher than
20.00%. Six drugs including gemcitabine， isocyclophosphamide and cyclophosphamide were detected in the PIVAS environment of
our hospital， and the residue of cyclophosphamide was relatively high. The optimal cleaning procedure was cleaning once with
water + cleaning once with 1 000 mg/L chlorine-containing disinfectant + cleaning once with 75% alcohol， wiping with dry gauze
method. The results of alcohol volatilization test showed that there was no significant difference in drug residues between control
group and 75% alcohol group （P＞0.05）. The results of CCK-8 test showed that compared with control group， the survival rates of
the cells treated with 15 cytotoxic antineoplastic drugs were decreased significantly （P＜0.01）； the survival rates of the cells treated
with 15 cytotoxic antineoplastic drugs+chlorine-containing disinfectant were significantly higher than those treated with 15
cytotoxic antineoplastic drugs （P＜0.01）. CONCLUSIONS A method for the simultaneous determination for residues of 15
cytotoxic antineoplastic drugs such as gemcitabine in PIVAS is successfully established； the optimal cleaning procedure can
significantly reduce the residues of drugs， the use of chlorine-
Δ 基金项目 江苏省科技项目基础研究计划（自然科学基金）-面上 containing disinfectant can significantly reduce the toxicity of
项目（No.BK20211072）；苏州市科技局民生科技-关键技术应用专项课 drug， and the residual drugs will not cause secondary
题（No.SS2019042）；苏州市科技发展计划-医疗卫生科技创新应用基
contamination of the operating area with alcohol volatilization.
础研究项目（No.SKJYD2021164） KEYWORDS pharmacy intravenous admixture service；
＊ 第一作者 主 管 药 师 。 研 究 方 向 ：药 事 管 理 。 E-mail：
gengzhouaa@163.com UPLC-Q-Orbitrap-HRMS； cytotoxic antineoplastic drugs；
# 通信作者 主任药师，硕士。研究方向：临床药学、药事管理。E- environmental residues detection； environmental residues clean
mail：panzy1122@163.com

中国药房 2023年第34卷第2期 China Pharmacy 2023 Vol. 34 No. 2 · 217 ·