ABSTRACT
OBJECTIVE:To investigate the compatible stability of Calcium folinate for injection mixed with Glucose injection and Sodium chloride injection. METHODS:Referring to clinical common concentration,each 3 Calcium folinate for injection (each injection was equal to calcium folinate 100 mg)were respectively mixed with Glucose injection 250 mL or Sodium chloride injection 250 mL. At room temperature,under light or dark condition,the appearance of mixtures,pH value and the number of in-soluble particles were investigated 0,1,2,3,4,6,8,12,24,36,48 h. The contents of calcium folinate in mixtures were deter-mined by HPLC. RESULTS:Under above condition,the color of the mixtures had no change,and no gas,precipitation and turbid-ity was found;there was no evident change in pH values(RSD<2%,n=11). 0 h after mixing,there was large number of parti-cles≥10 μm in mixtures,but the number of particle was decreased as time;within 48 h,the number of particles ≥10 μm and ≥25 μm in mixtures were all in line with the standard of Chinese Pharmacopeia(2015 edition). Under the protection from light con-dition,relative contents of calcium folinate in mixtures had no significant change(RSD<2%,n=11). Under light condition,rela-tive contents of calcium folinate in mixtures decreased significantly,decreasing to 94.5%(mixed with Glucose injection) and 88.4%(mixed with Sodium chloride injection). CONCLUSIONS:Calcium folinate for injection is more stable in Glucose injec-tion,and the stability of compatibility can be affected by light conditions. After mixed with Glucose injection and Sodium chloride injection,Calcium folinate for injection should be kept away from light and used as soon as possible