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.

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