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

机译:0.9%氯化钠注射液中地佐辛和托吡酯的相容性和稳定性用于患者自控镇痛

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摘要

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.
机译:Tropisetron是用于地佐辛的佐剂,用于静脉内自控镇痛(PCA),据报道可提供出色的疼痛控制。它可有效减少术后恶心和呕吐(PONV)的机构发生率,从而降低资源利用率和成本。然而,在文献中没有科学证据证明对地佐辛与托吡司琼的组合具有相容性和稳定性。因此,本研究旨在研究以0.9%氯化钠注射液形式的托佐司琼与托克司琼用于PCA给药的稳定性。将地佐辛和tropisetron的商业溶液组合在一起,并考察以0.9%氯化钠注射液稀释在聚烯烃袋中的相容性和稳定性。和玻璃瓶分别在4°C或25°C下保存14天。初始浓度为40μmg/100μmL地佐辛和5μmg/100μmL的托吡司琼。对于所有样品,均评估了相容性参数(包括沉淀,浑浊,变色和pH值)。化学稳定性也通过高效液相色谱(HPLC)分析确定。在4°C或25°C下保存14天后,地佐辛和托洛司琼的初始浓度至少保持在98%。在整个观察期内,所有混合物均保持透明无色,未观察到颜色变化或沉淀。这些结果表明,在0.9%氯化钠注射液中,40 mg / 100 mL地佐辛和5 mg / 100tropmL托克司琼的混合物对在4°C或25°C的温度下存放在聚烯烃袋或玻璃瓶中至少14天,并避光。

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