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一种新型仪器对静脉化疗药物和阿片类药物的化学降解作用

Chemical Degradation of Intravenous Chemotherapy Agents and Opioids by a Novel Instrument.

作者信息

Macdonell Mark, Kawedia Jitesh D, Zhang Yan Ping, Roux Ryan, Myers Alan L

机构信息

Clear River Enviro, Inc., Sugar Land, TX, USA.

University of Texas MD Anderson Cancer Center, Houston, TX, USA.

出版信息

Hosp Pharm. 2021 Oct;56(5):576-583. doi: 10.1177/0018578720931456. Epub 2020 Jun 8.

Abstract

To assess chemical degradation of various liquid chemotherapy and opioid drugs in the novel RxDestruct™ instrument. Intravenous (IV) drug solutions for chemotherapy and pain management were prepared using 0.9% normal saline in Excel bags to a final volume of 500 mL. We investigated duplicate IV solutions of methotrexate (0.1 mg/mL), etoposide (0.4 mg/mL), doxorubicin (0.25 mg/mL), cladribine (12.4 µg/mL), fentanyl (1.0 µg/mL), and hydromorphone (12.0 µg/mL) in this study. Solutions were poured into an automated instrument to undergo pulsatile chemical treatment (Fenton reactions) for 20 minutes, and then discharged from the instrument through a waste outlet. Extent of intact drug degradation was determined by measuring concentrations of drugs before entry into the instrument and after chemical treatment in the filtrate using high-performance liquid-chromatography with ultraviolet detection (HPLC-UV). Following chemical reactions (Fenton processes) in the automated instrument, infusion solutions containing methotrexate, etoposide, doxorubicin, and cladribine had levels below the HPLC-UV limit of quantification (LOQ), indicating <50 ppb of each. This equated to >99.5%, 99.99%, 99.9%, and 99.8% intact drug loss, respectively. Likewise, processed samples of fentanyl and hydromorphone contained levels below the LOQ (78 and 98 ng/mL, respectively), indicating extensive degradation (>92.2% and 99.2% intact drug loss, respectively). The novel instrument was capable of degrading intact chemotherapy and opioid drugs prepared in infusion solutions to undetectable quantities by HPLC-UV. RxDestruct™ is a possible alternative for disposal of aqueous medication waste.

摘要

评估新型RxDestruct™仪器中各种液体化疗药物和阿片类药物的化学降解情况。使用Excel袋中的0.9%生理盐水制备用于化疗和疼痛管理的静脉注射(IV)药物溶液,最终体积为500 mL。在本研究中,我们研究了甲氨蝶呤(0.1 mg/mL)、依托泊苷(0.4 mg/mL)、多柔比星(0.25 mg/mL)、克拉屈滨(12.4 μg/mL)、芬太尼(1.0 μg/mL)和氢吗啡酮(12.0 μg/mL)的重复IV溶液。将溶液倒入自动化仪器中进行脉动化学处理(芬顿反应)20分钟,然后通过废物出口从仪器中排出。通过使用带紫外检测的高效液相色谱法(HPLC-UV)测量进入仪器前和化学处理后滤液中药物的浓度,确定完整药物的降解程度。在自动化仪器中进行化学反应(芬顿过程)后,含有甲氨蝶呤、依托泊苷、多柔比星和克拉屈滨的输注溶液水平低于HPLC-UV定量限(LOQ),表明每种药物的含量<50 ppb。这分别相当于完整药物损失>99.5%、99.99%、99.9%和99.8%。同样,芬太尼和氢吗啡酮的处理样品中含量低于LOQ(分别为78和98 ng/mL),表明降解程度很高(完整药物损失分别>92.2%和99.2%)。这种新型仪器能够将输注溶液中制备的完整化疗药物和阿片类药物降解至HPLC-UV无法检测的量。RxDestruct™是处理水性药物废物的一种可能替代方法。

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