多烯磷脂酰胆碱注射液的体外配伍稳定性研究

目的研究多烯磷脂酰胆碱注射液与注射用还原型谷胱甘肽、注射用丁二磺酸腺苷蛋氨酸冻千粉、果糖二磷酸钠注射液、维生素c注射液等配伍的稳定性，探索配伍禁忌的根源和性质。方法采用高效液相色谱法测定多烯磷脂酰胆碱注射液与还原型谷胱甘肽等注射剂不同比例配伍前后溶液的含量，并观察配伍溶液的外观、pH值、微粒以及含量的变化。色谱柱：20RBAXEclipseXDB-C18（4．6mm×150mm，5“m）；流动相：甲醇一磷酸（40：60）；柱温：30℃；检测波长：205nm；流速：1．0ml／min；进样量：20¨l；检测器：DAD。结果多烯磷脂酰胆碱注射液用氯化钠注射液稀释产生白色浑浊；多烯磷脂酰胆碱注射液与还原型谷胱甘肽等注射剂配伍后，24h内溶液的含量、pH值、微粒等均产生明显的变化。结论上述各药与多烯磷脂酰胆碱注射液注射液配伍后，溶液的稳定性较差，多烯磷脂酰胆碱注射液不能与还原性谷胱甘肽等注射剂配伍。

Stability of in-vitro compatibility of polyene phosphatidylcholine injection

Objective To investigate the stability of compatibility of polyene phosphatidylcholine and reduced glutathione, succinic acid-adenosylmethionine, fructose sodium diphosphate, vitamin C, and the causes and nature of the incompatibi- ty. Methods A HPLC method was applied to determine the concentration of polyene phosphatidylcholine in the mixture with dif- ferent density and to observe the change of mixture at the appearance, pH, particulate and concentration. The column was 20RBAX Eclipse XDB-C18 （4. 6 mm x 150 ram, 5 p~m） , the mobil phase was methyl alcohol-Phosphoric acid （40：60） , 30 ~C , and detected wave-length was 205 nm, the flow rate was 1.0 ml/min. Results Polyene phosphatidylcholine injection diluted with sodium chloride injection producted with turbidity, In the 24 hours polyene phosphateidylcholine had obvious change at the appearance, pH, particulate and concentration. Conclusion It has not stability that the mixture of polyene phosphatidylcholine and reduced glutathione; succinic aeid-adenosylmethionine; fructose sodium diphosphate; Vitamin C. The Polyene phosphatidyl- choline can not be compatible with injections such as reduced glutathione.