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OBJECTIVE To evaluate the effects of drug release for gliclazide sustained-release tablets in ethanolic media and conduct the risk assessment for the dose dumping. METHODS Release profiles of gliclazide sustained-release tablets from 3 manufactures in different ethanolic media were determined by HPLC.Release mechanisms were analyzed and the risk of dose dumping was evaluated by the similar factors (f2) of the release data. RESULTS Release profiles of formulations in the presence of 5%, 20% and 40% ethanol of pH 7.4 phosphate buffer media at 100 r·min-1 were similar.The erosion rate was the key factor that affected the release profiles of gliclazide sustained-release tablets. CONCLUSION The commercial formulations are considered to be robust against alcohol effects and the risk of alcohol-induced dose dumping is relatively little.
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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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