患儿腹部手术后常用药物配伍小儿电解质补给注射液的稳定性研究  

Stability study of commonly used drugs in children after abdominal surgery compatibility with pediatric electrolyte supplements injection

作　　者：邵苗苗 程青 李英[1] 关玮伟 胡利华[1] 王晓玲[1] Miaomiao Shao;Qing Cheng;Ying Li;Weiwei Guan;Lihua Hu;Xiaoling Wang(Department of Pharmacy,Beijing Children′s Hospital,Capital Medical University,National Center for Children′s Health,Beijing 100045,China;School of Basic Medicine and Clinical Pharmacy,China Pharmaceutical University,Nanjing 210008,Jiangsu Province,China)

机构地区：[1]国家儿童医学中心/首都医科大学附属北京儿童医院药学部,北京100045 [2]中国药科大学基础医学与临床药学学院,南京210008

出　　处：《中华妇幼临床医学杂志（电子版）》2022年第6期731-738,共8页Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition)

基　　金：北京儿童健康基金会药学学科建设专项子项目(BCHF2020KY001)。

摘　　要：目的探讨腹部外科手术后患儿的7种常用药物(D1~7)[D1~7依次为维生素B6(Vit B6)、盐酸氨溴索(AH)、盐酸昂丹司琼(OH)、地塞米松磷酸钠(DSP)、甲泼尼龙琥珀酸钠(MPSS)、酚磺乙胺、氯化钾(KCl)],分别配伍小儿电解质补给注射液(PESI)的稳定性。方法按照模拟腹部外科手术后患儿临床静脉注射用药配伍方案,将D1~7分别配伍PESI方案纳入研究组1~7,将D1~7分别配伍5%葡萄糖注射液(GI)、0.9%氯化钠(NaCl)注射液、0.9%NaCl注射液、0.5%GI、0.5%GI、0.9%NaCl注射液、0.9%NaCl注射液方案纳入对照组1~7。在(25±1)℃及正常光照条件下,分别观察不同时间点(配伍后0、1、2、4、8、24 h)研究组1~7与对照组1~7的外观、可见异物,并参照《中华人民共和国药典(2020年版)》pH值测定法与含量测定法,测定研究组1~7与对照组1~7的pH值、D1~7百分含量[高效液相色谱法(HPLC)、硝酸银(AgNO3)滴定法]。若研究组1~7与对照组1~7在不同时间点pH值、D1~7百分含量相对标准偏差(RSD)绝对值≤5%,则判断该配伍制剂在一定时间内pH值、药物相对含量的稳定性好。结果在(25±1)℃、正常光照条件下,对研究组1~7与对照组1~7外观观察与pH值、D1~7百分含量测定结果显示,D1~5配伍后8 h内,D6配伍后4 h内,D7配伍后24 h内:①各观察时点,研究组1~7与对照组1~7均澄清、透明,均无明显颜色变化,均未检出明显可见异物;②不同时间点,研究组1~7与对照组1~7的pH值RSD分别为0.13%与0.13%、0.10%与0.09%、0.63%与0、0.25%与0.15%、0.17%与0.11%、0.46%与0.22%、0.50%与0.54%,D1~7百分含量RSD分别为0.47%与0.17%、0.53%与0.35%、0.68%与0、0.21%与0.56%、2.02%与2.25%、0.16%与0.32%、0.12%与0.27%,均≤5%。结论本研究D1~7+PESI配伍制剂与D1~7配伍0.9%NaCl注射液或5%GI配伍制剂,在上述观察时间点D1~7稳定性均良好。Objective To investigate the stability of seven commonly used drugs(D1-7)in children after abdominal surgery[D1-7 was vitamin B6(Vit B6),ambroxol hydrochloride(AH),ondansetron hydrochloride(OH),dexamethasone sodium phosphate(DSP),methylprednisolone sodium succinate(MPSS),etamsylate and KCl in turn]compatibility with pediatric electrolyte supplements injection(PESI)respectively.Methods By simulating the clinical intravenous drug dosing regimen in children after abdominal surgery,D1-7 compatibility with PESI regimen were included into study group 1-7,respectively,and D1-7 compatibility with 5%glucose injection(GI),0.9%sodium chloride(NaCl)injection,0.9%NaCl injection,0.5%GI,0.5%GI,0.9%NaCl injection,0.9%NaCl injection regimen were included into control group 1-7.The appearance,visible abnormal material of study group 1-7 and control group 1-7 were observed at different time points(0,1,2,4,8 and 24 h after compatibility)under room temperature(25±1)°C and normal light,respectively,and pH value and D1-7 percentage content[high performance liquid chromatography(HPLC),AgNO3 titration]in study group 1-7 and control group 1-7 were detected with reference to the pH detection method and content detection method of the Pharmacopoeia of the People′s Republic of China(2020 Edition).If the absolute value of relative standard deviation(RSD)of pH value and D1-7 percentage content in study group 1-7 and control group 1-7 at different time points were≤5%,then the compatibility preparation was judged to have good stability in pH and relative content over a certain period of time.Results Under(25±1)℃and normal light conditions,the results of appearance,pH value and D1-7 percentage content of study group 1-7 and control group 1-7 showed that within 8 h after compatibility of D1-5,within 4 h after compatibility of D6 and within 24 h after compatibility of D7:①At each observation time point,study group 1-7 and control group 1-7 all were clarified and transparent,had no obvious color changes,and no obvious visible abnormal mat

关 键 词：小儿电解质补给注射液 配伍稳定性 维生素B6 盐酸氨溴索 盐酸昂丹司琼 地塞米松磷酸钠 甲泼尼龙琥珀酸钠 酚磺乙胺 氯化钾 小儿用药 

分 类 号：R726.1[医药卫生—儿科]