复合袋密封包装的八种饮片有效期研究
1. 大参林医药集团股份有限公司工业中心, 广东广州 510378
2. 广西紫云轩中药科技有限公司, 广西玉林 537000
| 摘 要： | 通过对8种中药饮片的外观特征、水分和指标成分含量的测定考察其有效期。八种饮片共计24批样品均采用相同的复合袋密封包装并按《中国药典》2020年版规定储存。所有样品均于第0、3、6、9、12、18、24个月取样，观察各样品的性状并测定其水分含量及指标成分含量。采用GraphPad Prism 5与Minitab 21软件对结果进行分析。在研究期内，所有样品的外观性状和水分含量均无显著变化。在八种饮片中，猪苓指标成分含量没有明显变化，而其他中药的指标成分随着时间的推移呈明显下降趋势，其中，地黄指标成分含量下降速度最快，续断指标成分含量下降速度最慢。由回归拟合曲线可知，塑料复合袋密封包装的八种中药的保质期分别为燀苦杏仁40个月、川芎20个月、吴茱萸20个月、川椒12个月、川断片81个月、地黄24个月、黑顺片26个月、猪苓24个月。在研究期间，除花椒外的其他七种饮片的质量均符合相关规定。本研究说明中药饮片的有效期研究是有意义的，稳定性回归分析方法可用于预测中药饮片的有效期。 |
| 关 键 词： | 中药; 有效期; 回归分析 |
| DOI： | 10.57237/j.cmrd.2023.02.001 |
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收稿日期: 2023-03-13
接受日期: 2023-04-15
在线出版日期: 2023-04-25
Shelf Life of Eight Chinese Herbs Sealed in Composite Bags
1. Dashanlin Pharmaceutical Group Co., Ltd, Guangzhou 510378, China
2. Guangxi Ziyun Xuan Chinese Medicine Technology Co., Ltd, Yulin 537000, China
| Abstract: | The shelf life of eight traditional Chinese medicine (TCM) was investigated by examining their appearance, moisture content, and index component content. A total of 24 batches of samples of the eight TCM were packaged in the same composite bags and stored according to the requirements of the 'Chinese Pharmacopoeia' 2020 edition. Samples were taken at 0, 3, 6, 9, 12, 18, and 24 months, and the appearance, moisture content, and content of index components were measured. The results were analyzed using GraphPad Prism 5 and Minitab 21 software. During the study period, there were no significant changes in the appearance or moisture content of all samples. Among the eight TCM, the index component content of polyporus umbellatus did not change significantly, while that of the others showed a clear downward trend over time. Among them, rehmanniae radix and dipsaci radix slices had the fastest and slowest decline in index component content, respectively. The regression-fitting curve indicated that the shelf life of the eight TCM packed in composite plastic bags was 40 months for armeniacae semen amarum processed with boiling water, 20 months for chuanxiong rhizoma, 20 months for euodiae fructus, 12 months for zanthoxyli pericarpium, 81 months for dipsaci radix slices, 24 months for rehmanniae radix, 26 months for heishunpian (aconiti lateralis radix praeparata), and 24 months for polyporus umbellatus. During the study period, the quality of all eight TCM, except for zanthoxyli pericarpium, met the relevant requirements. The study demonstrates the research on the shelf life of TCM is significant and stability regression analysis can be used to predict the shelf life. |
| Keywords: | Chinese Herbs; Shelf Life; Regression Analysis |
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