摘要
目的:考察葡萄糖酸钙注射液与不同溶媒配伍24 h内的稳定性,为临床用药提供参考。方法:将10%葡萄糖酸钙注射液分别均按体积比10∶100、30∶100、50∶100与0.9%氯化钠注射液、5%葡萄糖注射液混合,作为试验组输液;将其与10%葡萄糖注射液同比例混合,作为对照组输液;将水分别与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液同比例混合,作为空白对照组输液;于配制后24 h内观察试验组输液和对照组输液的外观,检测两者pH值、不溶性微粒数量并与空白对照组进行比较。采用紫外分光光度法测定5-羟甲基糠醛含量及紫外吸收光谱的变化情况。结果:与同一时间的空白对照组输液比较,试验组输液和对照组输液在24 h内均为无色、澄清溶液,无可见异物,且试验组输液与对照组输液的pH值无明显变化。在配制后的24 h内,3组输液中≥10、≥25μm的不溶性微粒数虽有波动,但符合药典标准;小粒径(5~10μm)不溶性微粒数量有随时间的延长略呈上升趋势,但试验组输液、对照组输液和空白对照组输液无明显差异。5-羟甲基糠醛检测质量浓度的线性范围为0.149~4.751μg/mL(R 2=0.9999);定量限为0.013μg/mL;精密度、重复性、稳定性(24 h)试验的RSD均小于2%;平均回收率为105.23%(RSD=1.08%,n=9)。试验组输液与对照组输液中5-羟甲基糠醛的含量以及其紫外吸收图谱在24 h内均无明显变化;于284 nm波长处测定的吸光度符合药典规定。结论:葡萄糖酸钙注射液与0.9%氯化钠注射液、5%葡萄糖注射液配伍后所得输液在24 h内稳定性良好,可根据临床需要配伍使用。
OBJECTIVE:To investigate the compatibility stability of Calcium gluconate injection with different solvents within 24 h,and to provide reference for clinical drug use.METHODS:10%Calcium gluconate injection was mixed with 0.9%Sodium chloride injection and 5%Glucose injection in the proportion of 10∶100,30∶100 and 50∶100(v/v)as trial group,and mixed with 10%Glucose injection in the same proportion as control group.The water was mixed with 0.9%Sodium chloride injection,5%Glucose injection and 10%Glucose injection in the same proportion as the blank control group.The appearance of the infusion in the trial group and the control group was observed within 24 h after preparation.pH value and the number of insoluble particles were detected and compared with the blank control group.The content of 5-hydroxymethylfurfural and the change of UV absorption spectrum were determined by UV spectrophotometry.RESULTS:Compared with the blank control group infusion at the same time,the infusion of trial group and the control group were colorless,clear solution,no visible foreign body,and the pH value of the infusion of trial group and the control group had no significant change within 24 h.Within 24 h after preparation,the number of insoluble particles≥10 and≥25μm in 3 groups fluctuated but met the pharmacopoeia standard;the number of insoluble particles with small particle size(5-10μm)increased slightly with time,but there was no significant difference between trial group,control group and blank control group.The linear range of 5-HMF was 0.149-4.751μg/mL(R 2=0.9999);the limit of quantitation was 0.013μg/mL;RSDs of precision,repeatability and stability tests(24 h)were less than 2%;average recovery was 105.23%(RSD=1.08%,n=9).The content of 5-HMF and the UV absorption spectrum had no significant change in 2 groups within 24 h.The absorbance of UV measured at 284 nm was in line with the pharmacopeia.CONCLUSIONS:Calcium gluconate injection,0.9%Sodium chloride injection and 5%Glucose injection have good stability within 24
作者
张文佳
孙德清
ZHANG Wenjia;SUN Deqing(Dept.of Drug Supply,the Second Hospital of Shandong University,Jinan 250033,China)
出处
《中国药房》
CAS
北大核心
2021年第10期1230-1235,共6页
China Pharmacy
基金
山东省重点研发计划项目(No.2018GSF118024)。
关键词
葡萄糖酸钙注射液
溶媒
稳定性
配伍
Calcium gluconate injection
Solvent
Stability
Compatibility
