果糖冻干粉针及葡萄糖注射液与多烯磷脂酰胆碱注射液配伍后的微粒观察

目的 观察果糖冻干粉针、葡萄糖注射液分别与多烯磷脂酰胆碱注射液配伍前、后不溶性微粒的变化和配伍情况,为临床选择不同溶媒与多烯磷脂酰胆碱注射液配伍提供参考.方法 用pH计测定各溶液的pH,并按照"不溶性微粒检查法",采用ZWF-J6激光注射液微粒分析仪检查微粒的变化.结果 各溶液配伍后pH没有太大的变化,且溶液澄清,但多烯磷脂酰胆碱注射液与果糖冻干粉针配伍较多烯磷脂酰胆碱注射液与葡萄糖注射液配伍后的微粒数明显增加配伍后[直径≥10 mm的5%果糖注射液微粒数为(111.4±0.13)粒,10%果糖注射液为(154.90±2.31)粒,葡萄糖注射液为(5.40±0.20)粒,10%葡萄糖注射液为(25.00±10.00)粒;直径≥25 μm的微粒数分别为(2.00±0.35)粒、(2.20±0.00)、(0.10±0.01)、(0.20±0.04)粒]但未超过药典规定.结论 果糖冻干粉针可以与多烯磷脂酰胆碱注射液配伍,但要考虑对不溶性微粒数的控制.

Abstract：

Objective To observe the change of insoluble particles of fructose for injection and glucose solution after compatibility of polyene phosphatidylcholine injection. Methods The pH meter was used to determine the pH of each solution and the particles through usage of ZWF-J6 laser analyzer of particles of injection was checked according to "Insoluble Particles Test". Results There was little change of pH after compatibility of various solutions and each solution was clear,but more particles were found in fructose solution than those in glucose solution after compatibility of polyene phosphatidylcholine injection and none of them exceeded the criterion according to pharmacopoeia. Conclusion The compatibility of fructose for injection and polyene phosphatidylcholine injection is feasible,but the control of insoluble particles should be considered.

The observation of fructose particles for injection and glucose solution after compatibility of polyene phosphatidylcholine injection

Objective To observe the change of insoluble particles of fructose for injection and glucose solution after compatibility of polyene phosphatidylcholine injection. Methods The pH meter was used to determine the pH of each solution and the particles through usage of ZWF-J6 laser analyzer of particles of injection was checked according to "Insoluble Particles Test". Results There was little change of pH after compatibility of various solutions and each solution was clear,but more particles were found in fructose solution than those in glucose solution after compatibility of polyene phosphatidylcholine injection and none of them exceeded the criterion according to pharmacopoeia. Conclusion The compatibility of fructose for injection and polyene phosphatidylcholine injection is feasible,but the control of insoluble particles should be considered.