前列地尔注射液质量比较  

Pharmaceutical Evaluation of Alprostadil Injections from Different Manufacturers

作　　者：张相林[1] 

机构地区：[1]中日友好医院,北京100029

出　　处：《中国药物评价》2014年第5期302-305,共4页Chinese Journal of Drug Evaluation

摘　　要：目的:对不同厂家生产的前列地尔注射液质量进行比较与评价,为临床优选药品提供科学依据,为安全用药提供参考。方法:参考国家药品质量标准WS1-(X-041)-2002Z-2008和文献研究报道,用高效液相色谱法和紫外可见吸光度法,比较4个企业生产的前列地尔注射液样品K、M、X、Y在溶血性磷脂酰胆碱、杂质含量和种类、皮肤刺激性及配伍试验四个方面的差异,评估其安全性。结果:K在评估的各方面都表现出较好的性质。M质量最差,其溶血性磷脂酰胆碱0 d时已接近限度值,25℃加速10 d超标;未知杂质种类高达9种,含量约16.3%;皮肤刺激性较大。Y和X的未知杂质含量和种类偏高。结论:目前市场销售的前列地尔注射液质量差别较大,产品质量较好的可作为临床优选,产品质量较差的在临床使用存在一定安全隐患,其处方和工艺需要改进。Objective： To evaluate the qualities of alprostadil injections from different manufacturers, and provide reference for clinical application.Methods： The clinical medication safety of brand name product and different generic products were investigated according to the strict standards No.WS1-（X-041）-2002Z-2008 and relative literature through high performance liquid chromatography and ultraviolet spectrophotometry.The research priorities include lysophosphatidylcholine, unknown-impurity, skin irritation and incompatibility.Results：According to the experimental results, K showed excellent quality among the comparable products.While M have the worst quality, assay of lysophosphatidylcholine is near the ceiling limit value; nine kinds of unknown-impurity, totally 16.3%; high skin irritation.Y and X have much more unknown-impurity than K, suggesting bad safety.Conclusion： The quality differences between the alprostadil injections on the market were significant, which owning the better quality could be a better choices.Those products with poor qualities couldn′t be used as a good clinical selection because of the safety consideration,until the formulation and process were improved.

关 键 词：前列地尔注射液 质量比较 溶血性磷脂酰胆碱 未知杂质 皮肤刺激性 

分 类 号：R927[医药卫生—药学]