地佐辛稀释于0.9%氯化钠溶液中用于患者静脉自控镇痛的稳定性研究
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Stability study of dezocine in 0.9% sodium chloride solutions for patient-controlled analgesia administration
背景与目的
地佐辛是一种混合的阿片受体激动剂及拮抗剂，已被广泛用于静脉自控镇痛（PCA）以缓解患者术后疼痛。本研究的目的是探讨地佐辛稀释于0.9%氯化钠溶液中用于患者静脉自控镇痛（PCA）的化学稳定性。
方 法
将地佐辛制剂（0.3、0.45及0.6mg / mL的地佐辛稀释于0.9%的氯化钠溶液中）用聚烯烃袋和玻璃瓶存储。 研究了其在4℃条件下储存14天和25℃条件下储存72小时的稳定性。对于所有制剂，评估其物理特性（包括pH、颜色和沉淀物的生成）， 并使用稳定性指示反相高效液相色谱法分析了每种制剂的稳定性， 如果地佐辛制剂保持其初始浓度的至少90％，则该制剂则认为是稳定的。
结 果
在实验期间，在所制备的制剂中均没有观察到PH值、颜色及沉淀的显著变化，在所给出的储存条件下，所有地佐辛制剂均保持> 97％的初始浓度。
结 论
地佐辛制剂（0.3、0.45及0.6mg / mL的地佐辛稀释于0.9%的氯化钠溶液中）在用聚烯烃袋和玻璃瓶存储以避免光照并同时在4℃条件下储存14天和25℃条件下储存72小时的条件下用于患者静脉自控镇痛具有稳定性。
原始文献摘要
Fang BX1, Wang LH, Liu HM, Chen FC, Liu J. Stability study of dezocine in 0.9% sodium chloride solutions for patient-controlled analgesia administration Medicine (Baltimore). 2017 Sep;96(35):e7979. doi: 10.1097/MD.0000000000007979.
Abstract：
Background: Dezocine, a mixed agonist/antagonist of opioid receptors, has been used in iv patient-controlled analgesia (PCA) pumps for postoperative pain control. The aim of this study was to investigate the physicochemical stability of dezocine solutions in 0.9% sodium chloride for injection for PCA administration.
Methods: Solutions of dezocine (0.3, 0.45, or 0.6mg/mL in 0.9% sodium chloride for injection) were stored in polyolefin bags and glass bottles. Their stabilities at storage conditions of 4°C for 14 days and 25°C for 72hours were studied. For all preparations,physical characteristics (including pH, color, and presence of precipitates) were evaluated. Each preparation of dezocine was also analyzed using a stability-indicating high-performance liquid chromatography method. A solution was considered stable if it maintained at least 90% of its initial concentration.
Results:No notable changes in pH, color, or precipitation were observed in any of the prepared solutions over the testing period. All formulations maintained >97% of the initial dezocine concentration under the storage conditions evaluated.
Conclusions: Dezocine solutions at 0.3, 0.45, or 0.6mg/mL in 0.9% sodium chloride for PCA administration were stable for 72 hours at 25°C and for 14 days at 4°C when packaged in polyolefin bags or glass bottles and protected from light.
Abbreviations: HPLC = high-performance liquid chromatography, PCA = patient-controlled analgesia, QC = quality control, RSD= relative standard derivation.
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