| abstract |
The invention relates to the technical field of pharmaceutical preparations, and specifically discloses a tenofovir alafenamide fumarate tablet and a preparation method thereof. The tenofovir alafenamide fumarate tablet comprises the following components in percentage by weight: tenofovir alafenamide fumarate 12%-14%, cross-linking agent 10%-15%, diluent 45%- 58%, disintegrant 5%‑12%, sodium stearyl fumarate 1%‑5%, and calcium hydrogen phosphate 5%‑15%. The above raw and auxiliary materials are prepared into tenofovir alafenamide fumarate tablets by adopting a fluidized bed granulation method. In the present invention, through the selection of auxiliary materials, the proportion of optimized auxiliary materials and the fluidized bed granulation process, the tenofovir alafenamide fumarate tablet prepared has a high in vitro dissolution rate, low impurity content and good stability, which improves the safety of clinical application. The safety is consistent with the original research product in the four dissolution media, and the preparation process is simple, which is suitable for industrial production. |