注射用头孢匹林钠的配伍稳定性研究

The stability of cefapirin sodium for injection in some infusion fluids

目的考察注射用头孢匹林钠在使用过程中分别与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液的配伍稳定性。方法采用高效液相色谱法,使用C18色谱柱(SB-C18,4.6mm×250mm,5μm);流动相为0.05mol/L磷酸二氢钾溶液(用10%磷酸溶液调节p H值至2.6)-乙腈(88:12);检测波长为254nm;柱温为35℃;进样量为20μL。结果注射用头孢匹林钠分别与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液配伍使用,在6h内溶液的外观、p H值、有关物质及含量均无明显差异;但放置24小时后,有关物质或含量均已不合格。结论建议注射用头孢匹林钠与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液配伍应在6h内使用完毕。

Objective To study stability of cefapirin sodium for injection in 0.9% sodium chloride injection, 5% glucose injection, 10% glucose injection, respectively. Methods The RP-HPLC was as follows： column, Cas（SB-Ca8, 4.6mm×250mm, 5μm）; mobile phase, 0.05mol/L KHzPO4 buffer （ adjusted to pH2.6 with 10%H3PO4 solution）-acetonitrile （88：12）; UV detection wave length, 254nm; temperature of column, 35 ℃; injected value, 20μL. Results The appearance, pH, related compounds and contents of cefapirin sodium for injection in 0.9% sodium chloride injection, 5% glucose injection, 10% glucose injection respectively were stabile in 6 hours. After 24 hours, these were disqualified. Conclusions It is recommended to use the cefapirin sodium for injection in 0.9% sodium chloride injection, 5% glucose injection, 10% glucose injection, respectively, within 6 hours.