(S)-oxiracetam granule having fast dissolution speed, and preparation method thereof
A fast, granular technology, applied in non-active ingredients medical preparations, pharmaceutical formulations, inorganic non-active ingredients, etc., can solve the problems of difficult particle size control, easy adhesion, short shelf life, etc. Simple and feasible, not easy to absorb moisture and agglomerate, and the effect of less particle powder layer
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Embodiment 1
[0027] A kind of levoxiracetam granule with fast dissolving speed is 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 ethanol in the prescribed amount, stir to dissolve, and set aside;
[0031] 2. Pretreatment of raw and auxiliary materials: take the prescribed amount of levoxiracetam, mannitol, microcrystalline cellulose, sodium carboxymethyl cellulose, lactose, and low-substituted hydroxypropyl cellulose, put them in a universal grinder, grind them 100 mesh sieve, spare;
[0032] 3. Granulation: Take the mixed powder obtained after pretreatment, put it in a wet granulator, add the honey ethanol solution and polysorbate 80 prepared earlier, star...
Embodiment 2
[0079] A kind of levoxiracetam granule with fast dissolving speed is prepared according to the following steps:
[0080]
[0081]
[0082] 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. Gained finished product is tested by the test method of embodiment 1, and the Hughes angle test measurement result shows that the particles of this product have good fluidity, and the Hughes angle is lower than 34 °, and the loading difference test shows that the loading difference of this product is less than 4%. The filling capacity is stable and controllable. The dissolution test results show that the dissolution time of this product is less than 30 seconds, so the product can be quickly dissolved. The stability test results show that the quality of the sample is stable after 6 months of acceleration, and the lo...
Embodiment 3
[0084] A kind of levoxiracetam granule with fast dissolving speed is prepared according to the following steps:
[0085]
[0086] 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. Gained finished product is tested by the test method of embodiment 1, and the Hughes angle test measurement result shows that the particles of this product have good fluidity, and the Hughes angle is lower than 35 °, and the loading difference test shows that the loading difference of this product is less than 4%. The filling capacity is stable and controllable. The dissolution test results show that the dissolution time of this product is less than 30 seconds, so the product can be quickly dissolved. The stability test results show that the quality of the sample is stable after 6 months of acceleration, and the long-term 24 m...
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