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To establish in vitro and in vivo correlations from in vitro dissolution data and in vivo data from animals.
In vitro method: an aqueous gelatin solution was first prepared with alkaline gelatin, paliperidone palmitate was added into the solution and mixed well, gelatin hydrogel was obtained by refrigerating in the refrigerator for 1-2 h. The hydrogel was put into paddle dissolution apparatus for dissolution experiments, the concentration of the drug was detected by high-performance liquid chromatography and the degree of release was calculated. In vivo method: Timing was started after paliperidone palmitate was injected into Beagle dogs via intramuscular injection, blood was collected at 0 h before and 6 h-36 d after drug administration, respectively, the blood concentration was detected by liquid chromatography-tandem mass spectrometry (LC/MS/MS) technique and the blood concentration-time curve was plotted. Finally, the obtained in vitro data were fitted by Weibull function, the in vivo data were transformed by Nelson-Wagner method and area under the curve method. Graphs were constructed to evaluate the correlation between in vivo and in vitro drug release.
The in vitro release was approaching 100% by day 13, while the in vivo release was approaching 100% by day 30-36. Both Nelson-Wagner method and area under the curve method yielded that in vivo and in vitro were correlated.
It is feasible to establish in vitro correlations from in vivo dissolution data and in vivo data from animals.
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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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