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他克莫司胶囊分别用双铝、聚氯乙烯(PVC)/聚偏氯乙烯(PVDC)和PVC/三氟氯乙烯均聚物(ACLAR)包装,在加速条件下放置6个月,在多个时间点检测样品的性状、含量、溶出度、有关物质和水分,以选择较合适的上市包装。结果表明,双铝包装的产品有关物质降解较明显,PVC/PVDC铝袋加干燥剂包装的产品稳定性优于PVC/ACLAR铝袋加干燥剂,表明PVC/PVDC铝袋加干燥剂的包装能较有效阻隔水分、氧等,确保产品质量。
Tacrolimus capsules were individually packaged with double aluminum, polyvinyl chloride (PVC) / polyvinylidene chloride (PVDC) and PVC / chlorotrifluoroethylene homopolymer (ACLAR), placed under accelerated conditions for 6 months, A sample of the time point of detection of traits, content, dissolution, the relevant substances and water, to choose more suitable for market packaging. The results showed that the material degradation of double aluminum package was more obvious. The stability of PVC / PVDC aluminum bag plus desiccant package was better than that of PVC / ACLAR aluminum bag plus desiccant. It indicated that the packaging energy of PVC / PVDC aluminum bag plus desiccant More effective barrier moisture, oxygen, etc., to ensure product quality.