注射用亚叶酸钙与葡萄糖注射液、氯化钠注射液的配伍稳定性考察

Study on Compatible Stability of Calcium Folinate for Injection Mixed with Glucose Injection and Sodium Chloride Injection

目的:考察注射用亚叶酸钙与葡萄糖注射液、氯化钠注射液的配伍稳定性。方法:参照临床常用质量浓度,取注射用亚叶酸钙各3支(每支相当于亚叶酸钙100 mg),分别与葡萄糖注射液250 m L、氯化钠注射液250 m L配伍,在室温光照或避光条件下,分别于0、1、2、3、4、6、8、12、24、36、48 h考察各配伍液的外观,检测其p H值和不溶性微粒数,并采用高效液相色谱法测定各配伍液中亚叶酸钙的含量。结果:在上述条件下,各配伍液均未见颜色变化,也无气体、沉淀、浑浊等现象出现;p H值无明显变化(RSD<2%,n=11)。配制后0 h时,各配伍液中≥10μm的微粒数较多,但随着时间的延长,其数量有所下降,且48 h内各配伍液中≥10μm和≥25μm的微粒数均符合2015年版《中国药典》的规定。在避光条件下,各配伍液中亚叶酸钙的相对百分含量变化不大(RSD<2%,n=11);而在光照条件下,各配伍液中亚叶酸钙的相对百分含量明显降低,分别降至94.5%(与葡萄糖注射液配伍)和88.4%(与氯化钠注射液配伍)。结论:注射用亚叶酸钙在葡萄糖注射液中更稳定,且光照条件可影响其配伍稳定性。注射用亚叶酸钙与葡萄糖注射液、氯化钠注射液配伍后,应避光保存,并尽快使用。

OBJECTIVE ： To investigate and Sodium chloride injection. METHODS： （each injection was equal to calcium folinate the compatible stability of Calcium folinate for injection mixed with Glucose injection Referring to clinical common concentration, each 3 Calcium folinate for injection 100 rag） 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 insoluble particles were investigated 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 h. The contents of calcium folinate in mixtures were determined by HPLC. RESULTS： Under above condition, the color of the mixtures had no change, and no gas, precipitation and turbidity was found; there was no evident change in pH values （RSD〈2 %, n= 11）. 0 h after mixing, there was large number of particles ≥ 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 condition, relative contents of calcium folinate in mixtures had no significant change （RSD〈2 %, n = 11 ）. Under light condition, relative 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 injection, 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