注射用右雷佐生与几种配伍溶媒的稳定性考察  

Evaluation of Compatibilty and Stability of Dexrazoxane for Injection in Infusion Solutions

作　　者：宗在伟[1] 田帅华 刘红伟 王押林 张高雅 陈虹宇 ZONG Zaiwei;TIAN Shuaihua;LIU Hongwei;WANG Yalin;ZHANG Gaoya;CHEN Hongyu(Aosaikang PHARM,Nangjing 211112,China;Nanjing Medical University,Nangjing 210029,China)

机构地区：[1]江苏奥赛康药业有限公司,211112 [2]南京医科大学,210029

出　　处：《药学与临床研究》2022年第3期237-240,共4页Pharmaceutical and Clinical Research

摘　　要：目的:考察注射用右雷佐生与醋酸钠林格注射液、0.9%氯化钠注射液、5%葡萄糖注射液配伍后的稳定性,并与本品说明书中载明的乳酸钠林格注射液配伍后溶液的稳定性进行对比,以评估使用醋酸钠林格注射液、0.9%氯化钠注射液、5%葡萄糖注射液替代乳酸钠林格注射液的可行性。方法:建立右雷佐生有关物质测定的高效液相色谱法,模拟临床使用方法,用乳酸钠林格注射液或醋酸钠林格注射液配伍稀释成含右雷佐生浓度为1.3~3.0 mg·mL^(-1),用0.9%氯化钠注射液或5%葡萄糖注射液配伍稀释成含右雷佐生浓度为1.0~5.0 mg·mL^(-1),分别考察室温下0、1、2 h,2~8℃下0、2、4、6 h的稳定性。考察关键质量属性:有关物质、可见异物、不溶性微粒、溶液澄清度与颜色、pH。结果:注射用右雷佐生与醋酸钠林格注射液、0.9%氯化钠注射液、5%葡萄糖注射液配伍后溶液分别于2~8℃下放置6 h和室温下放置2 h,与乳酸钠林格注射液配伍后溶液稳定性趋势一致,均符合本品质量标准,稳定性良好。结论:在临床使用中,醋酸钠林格注射液、0.9%氯化钠注射液、5%葡萄糖注射液均可替代乳酸钠林格注射液使用,在规定的时间内稳定性较好。Objective:To investigate the in use stability of dexrazoxane for injection with sodium acetate Ringer injections,0.9%sodium chloride injections and 5%glucose injections,to assess alternative feasibilities of sodium lactate Ringer injections which is specified in the package inserts.Methods:An HPLC method was developed for the analysis of related substances in dexrazoxane.Following clinical procedures,dexrazoxane was diluted with sodium lactate Ringer injections or sodium acetate Ringer injections to a concentration of 1.3-3.0 mg·mL^(-1),or diluted with 0.9%sodium chloride injections or 5%glucose injections to a concentration of 1.0-5.0 mg·mL^(-1),and their stability for 6 h at 2~8℃or for 2 h at room temperature were investigated respectively.Critical quality attributes for assessing included related substances,visible particulates,particulate matter,completeness of solution,color of solution and pH.Results:Diluted with sodium acetate Ringer injections,0.9%sodium chloride injections or 5%glucose injections,the solutions were stable for 6 hours at 2-8℃or for 2 hours at room temperature,respectively.The stability of diluents met product specifications.ConclusionIn:Sodium acetate Ringer injections,0.9%sodium chloride injections and 5%glucose injections can be used as clinical alternatives to sodium lactate Ringer injections within specified time.

关 键 词：右雷佐生 配伍稳定性 有关物质 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学]