Full
Outline
To compare and analyze the performance of commonly used evaluation methods for dissolution curves, and explore more suitable alternative method when f2 factor cannot be used due to highly variable dissolution data.
Taking bicyclol tablets as example, 20 batches of dissolution data were collected and compared using different evaluation methods, including model-independent methods, model-dependent difference test, and model-dependent equivalence test of the model parameters.
Among the several model-independent methods, the results of the f2-bootstrap method were closer to the f2 method than the multivariate statistic distance (MSD) method when the dissolution data had greater variation (>10%). The results of t-test and MSD for comparing the parameters of model-dependent method were significantly different with the f2 method. The tolerance intervals of each parameter obtained by using model parameters for the first time could be used as the equivalent interval of model parameters for evaluation of dissolution consistency in the future.
When the f2 method is not applicable, the f2-bootstrap method can be used as an alternative method. The newly proposed equivalence interval of the model parameters can make up for the deficiency of t-test, and better evaluate the dissolution curves from the view of quality consistency.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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