氯化钙注射液包材变更质量研究

Study on the quality of packaging material change of calcium chloride injection

目的:依据国内外对药包材技术要求,进行氯化钙注射液的包材变更质量研究。方法:通过对包材的可提取物的测定评估中硼硅安瓿与氯化钙注射液的相容性,通过压力衰减法和微生物挑战试验评估包材的密封性。结果:中硼硅玻璃安瓿与氯化钙注射液相容性良好,且具有良好的密封性。结论:中硼硅玻璃安瓿对氯化钙注射液具有良好的保护作用,包材变更可行。

Objective:To study the quality of the packaging materials change for calcium chloride injection based on the domestic and foreign technical requirements for the packaging materials of pharmaceutical products.Methods:The compatibility of the calcium chloride injection with its contacted ampoules made of medium content of borosilicate glass and the sealability of the packaging material were evaluated by the determination of the extractables in the packaging materials and by the pressure decay and the microbial challenge tests,respectively.Results:The compatibility and the sealability were all good.Conclusion:The ampoules made of medium content of borosilicate glass has a good protective effect on calcium chloride injection and the change of packaging material is feasible.