(S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide granule and preparation method thereof
A technology of pyrrolidine acetamide and oxo, which is used in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. Slow speed and other problems, to achieve the effect of simple and feasible preparation process, not easy to absorb moisture and agglomerate, and to dissolve quickly
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Embodiment 1
[0027] A kind of (S)-4-hydroxyl-2 oxo-1-pyrrolidineacetamide granules, prepared according to the following steps:
[0028]
[0029] Preparation process:
[0030] 1. Preparation of adhesive: Take the prescribed amount of honey, put it in an iron pot, add purified water with 2 times the weight of honey, stir evenly, heat to 100-105°C, keep warm for 20-25 minutes, take it out, and use 80 Filter through a mesh sieve, take the filtrate, let it cool, add the ethanol of the prescription amount, stir and dissolve, and get final product;
[0031] 2. Pretreatment of raw and auxiliary materials: take the prescribed amount of (S)-4-hydroxy-2-oxo-1-pyrrolidineacetamide, L-cysteine, mannitol, microcrystalline cellulose, carboxymethyl cellulose Sodium, lactose, and low-substituted hydroxypropyl cellulose are placed in a universal pulverizer, pulverized through a 100-mesh sieve, and set aside;
[0032] 3. Granulation: Take the mixed powder obtained after the pretreatment, place it in a w...
Embodiment 2
[0075] A kind of (S)-4-hydroxyl-2 oxo-1-pyrrolidineacetamide granules, prepared according to the following steps:
[0076]
[0077] Preparation process: prepared according to the preparation process of Example 1. Observing the granulation process of the product did not find the phenomenon of sticking to the screen, and the product was easy to granulate. Tested by the test method of Example 1, the dissolution time measurement shows that this product has a fast dissolution rate, and the dissolution time of multiple samples is less than 30 seconds. The product prescription has an impact on the increase of impurities in the preparation process. The test results show that the impurities in the preparation process of this product The increase is small, and the related substances only increase by 0.02% in the preparation process; the stability test results show that the quality of the sample is stable in six months of acceleration, and stable in 24 months in a long-term period, so...
Embodiment 3
[0079] A kind of (S)-4-hydroxyl-2 oxo-1-pyrrolidineacetamide granules, prepared according to the following steps:
[0080]
[0081] Preparation process: prepared according to the preparation process of Example 1. Observing the granulation process of the product did not find the phenomenon of sticking to the screen, and the product was easy to granulate. Tested by the test method of Example 1, the dissolution time measurement shows that this product dissolves quickly, and the dissolution time of multiple samples is all less than 30 seconds. The test results of the impact of product prescription on the increase of impurities in the preparation process show that the impurities in the preparation process of this product The increase is small, and the related substances only increase by 0.03% in the preparation process; the stability test results show that the quality of the sample is stable in six months of acceleration, and stable in 24 months in a long-term period, so the val...
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