摘要
目的考察右雷佐生使用专用溶媒或非专用溶媒溶解后溶液的稳定性。方法右雷佐生分别用专用溶媒(0.167 mol/L乳酸钠注射液)或非专用溶媒(灭菌注射用水)溶解后,室温放置24 h;观察配伍液的外观变化,用pH计测定溶液pH值的变化,用微粒分析仪测量不溶性微粒数的变化,用超高效液相色谱法测定右雷佐生的相对百分含量变化。色谱条件:色谱柱ACQUITY UPLC BEH C18柱(2.1 mm×50 mm,1.7μm);流动相水-甲醇(90∶10);流速0.4 mL/min;检测波长209 nm;柱温25℃。结果各组配伍液在24 h内外观和pH值均无明显变化,专用溶媒组的配伍液pH值较非专用溶媒组高;用非专用溶媒溶解再扩容至5%葡萄糖注射液中的配伍液,不溶性微粒数超出规定值,其余均在规定范围内;右雷佐生的线性范围在4.30~42.96 mg/L(r=0.9999)。右雷佐生专用溶媒组相对百分含量配制后6 h内>95%,非专用溶媒组相对百分含量6 h内<95%。6 h以后各组配伍液的相对百分含量均明显降低。结论注射用右雷佐生使用专用溶媒配制后的稳定性优于非专用溶媒。
Objective To investigate the stability of dexrazoxane for injection in dedicated or non-dedicated infusion solvents.Methods After dissolved in dedicated solvent(0.167 mol/L sodium lactate for injection)and non-dedicated solvent(sterile water for injection)respectively,dexrazoxane was placed at room temperature for 24 h,and the changes in appearance were observed.The value of pH was measured with pH meter.The number of insoluble particles was surveyed by particle analyzer.The relative percentage contents were measured by ultra-high performance liquid chromatography(UPLC),and the chromatographic conditions were as follows:chromatographic column was ACQUITY UPLC BEH C18(2.1 mm×50 mm,1.7μm),the mobile phase was water-methanol(90∶10)with a flow rate of 0.4 mL/min,the detection wave length was set at 209 nm,and the column temperature was 25℃.Results Under this condition,the appearance and pH value had no significant change within 24 h.In comparison,the pH of a compatible fluid prepared with dedicated solvents was higher than that with sterile water for injection.The number of insoluble particles in the mixture dissolved by non-dedicated solvent and expanded to the compatibility solutions in 5%glucose injection exceeded the normal range,while the other compatibility solutions were within the normal range.The linear range of dexrazoxane was 4.30-42.96 mg/L(r=0.9999).The relative percentage of dexrazoxane in the dedicated solvent group and non-dedicated solvent group were more than 95%and less than 95%within 6 h,repectively.The relative percentage of dexrazoxane was significantly decreased after 6 h in both groups.Conclusion The compatibility solution of dexrazoxane dissolved by dedicated solvent is more stable than that in non-dedicated solvent group.
作者
张亚坤
刘剑
贡莹
陈玮
张志清
ZHANG Ya-kun;LIU Jian;GONG Ying;CHEN Wei;ZHANG Zhi-qing(Department of Pharmacy, the Second Hospital of Hebei Medical University, Shijiazhuang 050000, China)
出处
《河北医科大学学报》
CAS
2021年第3期334-338,共5页
Journal of Hebei Medical University
基金
河北省医学科学研究重点课题计划(20170107)。
关键词
丙亚胺
色谱法
超高效液相
专用溶媒
razoxane
chromatography,ultra-high performance liquid
Dexrazoxane
