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To compare the in vitro dissolution profiles of quetiapine fumarate tablets from different sources, in order to provide reference for the evaluation of quality consistency.
The solvents used in this study were 0.01 mol·L-1 hydrochloric acid, 0.1 mol·L-1 hydrochloric acid, pH 4.5 acetate buffer, pH 6.8 phosphate buffer and water, respectively, with the volume of 900 mL. The paddle method was applied at the rotation speed of 50 r·min-1. The content of quetiapine fumarate was determined by HPLC. The cumulative dissolution was calculated and the dissolution curves were obtained. Similarity factor (f2) method was used to evaluate the similarity of dissolution profiles.
Among the reference preparations from 5 different sources, the cumulative dissolutions in 15 min were all above 85% or the similarity factors (f2) greater than 50. The dissolution curves were similar and the dissolution behaviors were consistent. Among the domestic generic preparations from 5 different sources, product from manufacturer B in 0.1 mol·L-1 hydrochloric acid, products of 100 mg and 200 mg from manufacturer A in pH 6.8 phosphate buffer, the f2 were less than 50, which are not similar to the reference. The other batches have similar dissolution profiles to the reference preparations, thus their dissolution behavior are consistent.
The dissolution profiles of reference preparations from different sources are similar, and the dissolution behaviors are consistent. However, in a dissolution medium not specified in the pharmacopoeia of quetiapine fumarate tablets, a few domestic generic preparations from different sources have dissimilar dissolution profiles and inconsistent dissolution behaviors. In order to make a comprehensive assessment of the consistency of quetiapine fumarate tablets, the specific bioequivalence experiments and other indicators of pharmacy still needs to be integrated for the reference and domestic generic preparations from different sources.
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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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