不同包装和贮藏条件对熟地黄小包装饮片有效期的影响

目的:经长期留样考察,探讨不同包装材料和贮藏条件对熟地黄小包装饮片有效期的影响,确定熟地黄小包装饮片的有效期。方法:开展30个月的长期留样稳定性考察,对不同包装、不同贮藏条件的熟地黄饮片的性状、薄层鉴别、水分、浸出物、毛蕊花糖苷含量进行检测,确定熟地黄饮片的有效期。采用HPLC测定毛蕊花糖苷含量,检测波长334 nm,流动相乙腈-0.1%乙酸水溶液(16∶84)。结果:经过30个月的长期稳定性考察发现,在小包装下,性状、薄层鉴别、水分、浸出物含量均能达到《中国药典》2010年版对熟地黄的相关规定,而毛蕊花糖苷含量差异较大,影响的最大因素是包装材料,毛蕊花糖苷含量排序为药用铝箔袋聚乙烯塑料袋牛皮凝膜纸袋。在冷藏条件下,3种包装材料熟地黄饮片的有效期分别暂定为30,12,6个月。结论:确定了熟地黄小包装饮片的包材种类、贮藏条件及有效期,为中药小包装饮片的包装、贮藏及养护提供研究示范。

Validity Period of Rehmanniae Radix Praeparata Small Packaging Pieces in Different Packaging Materials and Storage Conditions

Objective: After observed long-term retention of samples,to investigate the effects of different packaging materials and storage conditions on the validity period of Rehmanniae Radix Praeparata small packaging pieces and determine their valid periods. Method: In order to determine the valid period of Rehmanniae Radix Praeparata small packaging pieces,through carrying out the 30-month long-term retention stability study,different packaging materials and storage conditions of Rehmanniae Radix Praeparata pieces were detected, including characters,moisture,contents of extract and verbascoside. Result: After 30 months of long-term stability study,as small packaging pieces,the characters,thin layer identification (TLC),moisture,content of extract could reach the relevant provisions in the 2010 edition of Chinese Pharmacopoeia.But the content of verbascoside had large difference,and the biggest factor was the impact of packaging materials.The content of verbascoside in descending order as following:medicinal aluminum foil bag > polyethylene plastic bag > leather condensate film paper.In the vacuum cold condition,the validity of three kinds of packaging materials for Rehmanniae Radix Praeparata pieces were 30,12,6 months. Conclusion: This study can determine the package types,storage conditions and period of Rehmanniae Radix Praeparata small packaging pieces,and it also can provide research and demonstration for the packaging storage and maintenance of small package pieces of traditional Chinese medicine.