Preparation method of amisulpride tablet
AssigneeHQ Pharma (Shandong) Co., Ltd.
InventorsYijun Song, Xinmeng Cui, Dekai Chang
Life of this patent
Estimating the term…
Abstract
The present disclosure belongs to the technical field of medicine preparation, and provides a preparation method of an amisulpride tablet. The preparation method includes the following steps: coating amisulpride with a coating material, and then mixing a hydrophilic lubricant with obtained coated granules. In the present disclosure, a brand new solution is provided for a sticking problem caused by inherent properties of the amisulpride. The amisulpride is coated with a polymer coating material, and then the coated granules are mixed with a highly hydrophilic lubricant. The preparation method avoids easy sticking of the amisulpride. Meanwhile, the prepared amisulpride tablet has high hardness and desirable dissolution rate.
Claims3
A preparation method of an amisulpride tablet, comprising the following steps:
- S1, granulation:
- conducting wet granulation on amisulpride with a coating material to obtain wet granules;
- wherein the coating material comprises ethyl cellulose and hydroxypropyl cellulose at a mass ratio of 1:1;
- S2, coating:
- subjecting the wet granules obtained in step S1 to coating with additional coating material, drying, and sieving to obtain coated granules;
- wherein the additional coating material comprises the ethyl cellulose and the hydroxypropyl cellulose at a mass ratio of 1:1;
- S3, first mixing:
- mixing the coated granules obtained in step S2 with a hydrophilic lubricant to obtain a material 1;
- wherein the hydrophilic lubricant is sodium stearyl fumarate, and is added at 0.5% to 1.5% of the weight of the amisulpride tablet;
- S4, second mixing:
- adding an auxiliary material into the material 1 obtained in step S3, and mixing to obtain a material 2;
- wherein the auxiliary material comprises at least one of a disintegrant, a filler, a sweetener, or a flavoring agent, and does not comprise a lubricant;
- S5, total mixing:
- mixing the material 2 obtained in step S4 with a hydrophobic lubricant to obtain a total mixture;
- wherein the hydrophobic lubricant is magnesium stearate, and accounts for 0.5% to 1.5% of the weight of the amisulpride tablet;
- and
- S6, compressing:
- compressing the total mixture obtained in step S5 to obtain the amisulpride tablet.
Dependencies are inferred from the claim text.