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地佐辛与托烷司琼在用于患者自控镇痛给药的0.9%氯化钠注射液中的配伍稳定性。

Compatibility and stability of dezocine and tropisetron in 0.9% sodium chloride injection for patient-controlled analgesia administration.

作者信息

Chen Peng, Chen Fuchao, Zhou Ben-Hong

机构信息

Department of Pharmacy, Renmin Hospital of Wuhan University, Wuhan, Hubei.

Department of Pharmacy, Dongfeng Hospital, Hubei University of Medicine, Shiyan.

出版信息

Medicine (Baltimore). 2018 Dec;97(50):e13698. doi: 10.1097/MD.0000000000013698.

Abstract

Tropisetron is an adjuvant for dezocine used in intravenous patient-controlled analgesia (PCA) and has been reported to provide superior pain control. It is efficacious in reducing the institutional incidence of postoperative nausea and vomiting (PONV), which decreases resource utilization and cost. However, no scientific evidence has been reported in the literature demonstrating analytical confirmation of the compatibility and stability of the combination of dezocine and tropisetron. Thus, the present study aimed to investigate the stability of dezocine with tropisetron in 0.9% sodium chloride injection form for PCA administration.Commercial solutions of dezocine and tropisetron were combined and examined for compatibility and stability when diluted with 0.9% sodium chloride injection in polyolefin bags and glass bottles stored at 4°C or 25°C for up to 14 days. The initial concentrations were 40 mg/100 mL dezocine and 5 mg/100 mL tropisetron. For all samples, the compatibility parameters (including precipitation, cloudiness, discoloration, and pH values) were evaluated. Chemical stability was also determined using high-performance liquid chromatographic (HPLC) analysis.After a 14-day period of storage at 4°C or 25°C, the initial concentrations of dezocine and tropisetron were maintained at at least 98%. All of the mixtures remained clear and colorless throughout the observation period, and no color change or precipitation was observed.These results indicated that admixtures of 40 mg/100 mL dezocine and 5 mg/100 mL tropisetron in 0.9% sodium chloride injection were stable for at least 14 days when stored in polyolefin bags or glass bottles at 4°C or 25°C and protected from light.

摘要

托烷司琼是地佐辛用于静脉自控镇痛(PCA)的辅助药物,据报道其能提供更好的疼痛控制。它在降低术后恶心呕吐(PONV)的发生率方面有效,这可减少资源利用和成本。然而,文献中尚未有科学证据证明地佐辛与托烷司琼联合使用的配伍性和稳定性的分析确认。因此,本研究旨在调查以PCA给药的0.9%氯化钠注射液形式存在的地佐辛与托烷司琼的稳定性。将地佐辛和托烷司琼的市售溶液混合,并在聚烯烃袋和玻璃瓶中用0.9%氯化钠注射液稀释后,于4℃或25℃储存长达14天,检查其配伍性和稳定性。初始浓度为40mg/100mL地佐辛和5mg/100mL托烷司琼。对所有样品评估配伍参数(包括沉淀、浑浊、变色和pH值)。还使用高效液相色谱(HPLC)分析确定化学稳定性。在4℃或25℃储存14天后,地佐辛和托烷司琼的初始浓度至少维持在98%。在整个观察期内,所有混合物均保持澄清无色,未观察到颜色变化或沉淀。这些结果表明,40mg/100mL地佐辛和5mg/100mL托烷司琼在0.9%氯化钠注射液中的混合物,当在4℃或25℃下储存在聚烯烃袋或玻璃瓶中并避光保存时,至少14天是稳定的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b48a/6319974/c2635e4ee4b2/medi-97-e13698-g001.jpg

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