| abstract |
The invention belongs to the technical field of medicine, and in particular relates to a low-NDMA, small-skeleton metformin hydrochloride sustained-release tablet and a preparation method. The low NDMA and small skeleton metformin hydrochloride sustained-release tablet of the present invention comprises the following components by mass fraction: metformin hydrochloride 25-80%; sustained-release matrix material 10-40%; release regulator 0.1-25%; adhesive 0.5-10% %; glidant 0.1-3%; lubricant 0.05-5%; antioxidant 0.01-5%. The low-NDMA and small-skeleton metformin hydrochloride sustained-release tablets of the present invention achieve low NDMA levels in a double-controlled manner, on the one hand, controlling NDMA not to exceed the limit, on the other hand, reducing the source of NDMA formation and reducing the proportion of hydrophilic gel skeleton materials, which is the current There are 60-69% of the weight of the similar hydrophilic gel matrix sustained-release tablet products on the market. |