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药用复合膜安全性影响因素分析

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目的 探讨影响药用复合膜安全性的因素,为进一步开展药用复合膜的相关研究提供参考。方法 检索相关文献,通过黏合剂、抗氧剂、荧光增白剂、增塑剂、溶剂残留5个安全性评价指标对药用复合膜进行安全性评价。结果 药用复合膜中未检出黏合剂、抗氧剂或检出量在限度范围内;荧光增白剂和增塑剂有检出,但目前尚无相关限度要求,无法判定其安全性;溶剂残留涉及溶剂种类较多,部分样品会超过限度要求。结论 药用复合膜安全性的影响因素较多,应从多方面综合评价。
Factors Affecting Safety of Medicinal Composite Films
Objective To investigate the factors affecting the safety of medicinal composite films,and to provide a reference for further research on medicinal composite films.Methods The relevant literature were searched to evaluate the safety of medicinal composite films with adhesive,antioxidant,fluorescent whitening agent,plasticizer,and residual solvent as safety evaluation indexes.Results No adhesive or antioxidant was detected in the medicinal composite films,or the detected amount was within the limit range.However,the fluorescent whitening agent and plasticizer have been detected,but there were no relevant limit requirements to determine their safety.There were many types of solvents involved in residual solvent,and some samples might exceed the limit requirement.Conclusion Many factors can affect the safety of medicinal composite films,and its safety should be comprehensively evaluated from multiple aspects.

medicinal composite filmssafety evaluationadditives

王子梦、马宁、王春霞、冯毅、耿燕

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河北省药品医疗器械检验研究院,河北 石家庄 050200

药用复合膜 安全性评价 助剂

2023年河北省药品监督管理局科技计划项目

2023ZC1009

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(17)