目的: 通过对中药饮片包装材料使用、材质类型、质量安全和法规等因素进行分析,提升对中药饮片包装质量控制的重视,为中药饮片用药安全提供保障。方法: 结合中药饮片包装现状、常用的各类包装材料,深入分析包装材料对中药饮片质量和安全性的影响,梳理相关法规针对中药饮片包装规范化问题,提出监管建议。结果与结论: 中药饮片包装有小包装中药饮片、直接口服粉末饮片和中药配方颗粒剂等,常用的包装材料有聚乙烯（PE）、药用复合膜（PET/VMPET/PE、PET/Al/PE）、聚对苯二甲酸乙二酯（PET）等。包装材料与中药饮片接触的过程中可能发生吸附、渗透、有毒有害成分迁移,对中药饮片的质量稳定性和安全性有一定的影响。尽管我国颁布了一系列相关法规,但目前中药饮片存在包装尚未统一、包装欠规范、包装材料与中药饮片性质不相符等问题,缺乏完善的质量评价体系。建议制定中药饮片包装材料的质量规范化标准及质量控制指标,促进中药饮片生产企业建立健全质量管理体系,推动中医药事业稳定高质量发展。
Objective: To enhance the importance of packaging quality control of traditional Chinese medicine(TCM) decoction pieces through the analysis of factors such as the use of packaging materials, material types, quality safety and regulations, and to provide protection for the safety of the use of TCM decoction pieces. Methods: Combined with the current situation of TCM decoction pieces packaging and various commonly used packaging materials, the impact of packaging materials on the quality and safety of TCM decoction pieces was deeply analyzed, and relevant laws and regulations were sorted out to address the standardization of TCM decoction pieces packaging and regulatory suggestions were put forward. Results and Conclusion: There are various packaging forms of Chinese herbal powders, including small packaging of Chinese herbal powders, direct oral powdered herbal products, and granule herbal formula products. Common packaging materials include polyethylene (PE), pharmaceutical composite film (PET/VMPET/PE, PET/Al/PE), and polyterephthalate (PET). During the process of contact between packaging materials and Chinese herbal powders, adsorption, permeation, and migration of toxic and harmful substances may occur, which has a certain impact on the stability and safety of Chinese herbal powders. Although China has enacted a series of related regulations, the packaging of Chinese herbal powders has not yet been standardized, the packaging is not well-regulated, and the packaging materials are not compatible with the properties of Chinese herbal powders. There is also a lack of a comprehensive quality evaluation system. It is suggested that standardized quality specifications and quality control indicators be established for Chinese herbal powder packaging materials, which will promote Chinese herbal powder manufacturers to establish and improve their quality management systems, and drive the stable and high-quality development of traditional Chinese medicine.
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