两种包装对医院乳膏制剂长期稳定性影响的研究

The effect of packaging on the permanent stability of medicinal cream preparations

目的:探讨两种不同包装对乳膏制剂长期稳定性的影响。方法:采用长期稳定性实验方法测定使用两种包装的3种乳膏制剂的装量及有效成分含量。结果:3种乳膏制剂使用新包装的与使用旧包装的样品,两种装量变化差异有统计学意义(P<0.05),且旧包装的装量及有效成份含量变化明显,制剂质量不稳定,故不宜使用。结论:包装方法对医院乳膏制剂长期稳定性影响大,我院改进包装后,新包装有助于确保乳膏制剂质量稳定。

Objective：To investigate the effect of the new and the old packaging on the permanent stability of cream preparations. Methods： The amounts and contents of effective ingredients of the cream preparetions packed with different packaging methods were determined and their permanent stability was analyzed. Results：The amounts and the contents of the effective ingredients of the cream preparations packed in old packaging changed a lot, not as good as those in new packaging in a period of one year （ P 〈 0.05 ）. Conclusions. Packaging method has a large effect on the permanent stability of medicinal cream preparations, so we must choose suitable packaging method to assure the quality of cream preparations.