不同包装对乳膏制剂稳定性的影响分析

Influence of Different Packaging on Stability of Cream Preparation

目的分析不同包装对乳膏制剂在长期稳定性试验条件下的影响。方法采用长期稳定性实验方法测定同一批号不同包装(药盒、铝质软管)和不同批号相同包装的尿素乳膏制剂的装量及有效成分含量。结果尿素乳膏制剂使用药盒包装与铝质软管包装样品,2种包装装量比较有显著性差异,有统计学意义(P<0.05),2组包装有效成分含量虽在规定范围,但也存在一定差异。结论不同的包装方法对乳膏制剂的长期稳定性影响比较大,铝质软管包装有助于确保乳膏制剂质量稳定性,值得临床推广使用。

Objective To analyze the influence of different packaging on the long-term stability of cream preparation under impact conditions.Methods The long-term stability method was used to determine the volume and the content of active components in the same batch of different package（box,aluminum hose） and different batches of the same packing urea ointment filling.Results The volume in urea cream preparations using packaging box and aluminum hose packaging samples had remarkable difference,with statistical significance（P0.05）,and the content of active components in 2 groups of packaging were both in the specified range,but there were also some differences.Conclusion The influence of different packing methods on the long-term stability of cream preparations is relatively large.Aluminum hose packaging helps to ensure the quality stability of cream preparations,and it is worth to promote in the clinical application.