艾司氯胺酮舒芬太尼布托啡诺甲氧氯普胺在0.9%氯化钠注射液中配伍稳定性考察

Compatible Stability of Esketamine,Sufentanil,Butorphanol and Metoclopramide in 0.9%Sodium Chloride Injection

目的考察盐酸艾司氯胺酮、枸橼酸舒芬太尼、酒石酸布托啡诺、甲氧氯普胺4种注射液在0.9%氯化钠注射液中的配伍稳定性,为术后镇痛的合理用药提供参考。方法模拟临床用药浓度将4种药物进行配伍,分别在室温避光和光照条件下于0、4、8、12、24、48 h取样,对其外观、pH值、药物相对百分含量和不溶性微粒进行测定。结果盐酸艾司氯胺酮、枸橼酸舒芬太尼、酒石酸布托啡诺、甲氧氯普胺配伍液在48 h内外观澄明,pH值为4.69~4.79,4种药物的相对百分含量为95%~105%,不溶性微粒数在4和8 h时均超过《中华人民共和国药典》(2020版)规定范围。结论在室温避光和光照条件下,配伍液外观、pH值、药物相对百分含量在48 h内均保持稳定,但不溶性微粒数超出规定标准。因此,不建议将上述4种药物与0.9%氯化钠注射液混合于镇痛泵中使用。

Objective To investigate the compatible stability of esketamine hydrochloride,sufentanil citrate,butorphanol tartrate,and metoclopramide in 0.9%sodium chloride injection,and to provide a reference for the rational use of medication for postoperative analgesia.Methods The four drugs were compounded by simulating the clinical concentrations of the drugs,and the samples were taken at 0,4,8,12,24 and 48 h under light-shielded and light-exposed conditions at room temperature.The appearance,pH value,relative drug content,and insoluble particles were determined.Results The appearance of esketamine hydrochloride,sufentanil citrate,butorphanol tartrate,and metoclopramide concoction was clear at 48 h.The pH values were in the range of 4.69 to 4.79,and the relative drug content of the four drugs were in the range of 95%to 105%.The number of insoluble particles exceeded the specified range in the Chinese Pharmacopoeia(2020 edition)at 4 h and 8 h.Conclusions Under light-shielded and light-exposed conditions at room temperature,the appearance,pH value and relative drug content of the compounded solution remained stable for 48 h.However,the number of insoluble particles exceeded the specified standard.Therefore,it is not recommended to mix the above 4 drugs with 0.9%sodium chloride injection for use in analgesic pumps.