Uniform-content (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide granule wand preparation method thereof
A technology of pyrrolidine acetamide and hydroxyl group, which is applied in the field of -4-hydroxy-2 oxo-1-pyrrolidine acetamide particles and their preparation, and can solve the problem of difficult particle size control, easy adhesion and short shelf life, etc. The problem is that the preparation process is simple and feasible, and it is not easy to absorb moisture and agglomerate, and the amount of particle powder layer is small.
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Embodiment 1
[0026] A kind of (S)-4-hydroxyl-2 oxo-1-pyrrolidineacetamide granule with uniform content is prepared according to the following steps:
[0027] Element
[0028] Make 1000 bags
[0029] Preparation process:
[0030] 1. Pretreatment of raw and auxiliary materials: take the prescribed amount of polysorbate 80, (S)-4-hydroxy-2-oxo-1-pyrrolidine acetamide and dissolve them in the prescribed amount of ethanol solution, and set aside; take another prescribed amount of , L-cysteine, mannitol, microcrystalline cellulose, sodium carboxymethyl cellulose, lactose, low-substituted hydroxypropyl cellulose, and sorbitol are placed in a universal pulverizer, pulverized through a 100-mesh sieve, and set aside;
[0031] 2. Granulation: Take the pre-treated mixed powder and place it in a wet granulator, add the previously treated (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide ethanol solution and the prescribed amount of starch slurry , start the granulator (18 mesh nylon sieves are in...
Embodiment 2
[0090] A kind of (S)-4-hydroxyl-2 oxo-1-pyrrolidineacetamide granule with uniform content is prepared according to the following steps:
[0091] Element
Dosage
(S)-4-Hydroxy-2-oxo-1-pyrrolidineacetamide
1 copy
L-cysteine
1.1 copies
Mannitol
0.9 parts
microcrystalline cellulose
1.5 servings
Sodium carboxymethyl cellulose
1.0 copies
lactose
1.2 parts
Talc powder
0.17 parts
polyethylene glycol 4000
1.5 servings
hypromellose
1.3 parts
Low-substituted hydroxypropyl cellulose
1.1 copies
Polysorbate 80
0.10 parts
Sorbitol
4 parts
Starch slurry with a mass fraction of 8%
15 copies
30% ethanol solution by volume fraction
5 copies
[0092] Make 1000 bags
[0093] Preparation process: prepared according to the preparation process of Example 1. Carry out the test by the test method of embodiment 1, the Hughes angle t...
Embodiment 3
[0095] A kind of (S)-4-hydroxyl-2 oxo-1-pyrrolidineacetamide granule with uniform content is prepared according to the following steps:
[0096] Element
Dosage
(S)-4-Hydroxy-2-oxo-1-pyrrolidineacetamide
1 copy
L-cysteine
1.0 copies
Mannitol
0.8 parts
microcrystalline cellulose
1.3 parts
Sodium carboxymethyl cellulose
0.9 parts
lactose
1.1 copies
Talc powder
0.16 parts
polyethylene glycol 4000
1.3 parts
hypromellose
1.2 parts
Low-substituted hydroxypropyl cellulose
1.0 copies
Polysorbate 80
0.08 copies
Sorbitol
3 copies
Starch slurry with a mass fraction of 7%
13 copies
25% ethanol solution by volume fraction
4 parts
[0097] Make 1000 bags
[0098] Preparation process: prepared according to the preparation process of Example 1. Carry out the test by the test method of embodiment 1, the Hughes angle test m...
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Abstract
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