Investigation on Compatibility Stability of Calcium Gluconate Injection with Different Solvents / 中国药房

ABSTRACT

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 ≥25 μm in 3 groups fluctuated but met the pharmacopoeia standard ；the number of insoluble particles with small particle size （5-10 μm）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 0.149-4.751 μg/mL（R2＝0.999 9）；the limit of quantitation was 0.013 μg/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 h，and can be used according to clinical needs.