Levo-oxiracetam granule and preparation method of same
A granule and prescription technology, which is applied in the direction of pharmaceutical formula, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of difficult control of particle size, easy adhesion and agglomeration, short shelf life, etc., to achieve The preparation process is simple and feasible, not easy to absorb moisture and agglomerate, and the effect of less granular powder layer
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Embodiment 1
[0026] A levo-oxiracetam granule, prepared according to the following steps:
[0027]
[0028] Preparation process:
[0029] 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;
[0030] 2. Pretreatment of raw and auxiliary materials: take the prescribed amount of levoxiracetam, fillers, and flavoring agents, put them in a universal grinder, grind them through a 100-mesh sieve, and set aside;
[0031] 3. Granulation: Take the mixed powder obtained after pretreatment, put it in a wet granulator, add binder, start the granulator (install 18-mesh nylon sieve), and start granulation;
[0032] 4. Drying: Put the wet granules into the fluidized bed, set the temper...
Embodiment 2
[0073] A levo-oxiracetam granule, prepared according to the following steps:
[0074]
[0075] 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. Prepared finished product is tested by the test method of embodiment 1, and the Hughes angle test measurement result shows that this product granule fluidity is good, and Hughes angle is lower than 33 °, and the loading difference test shows that this product loading difference is less than 5°. %, the loading of this product is stable and controllable. The results of the stability test show that the quality of the sample is stable in the accelerated period of 6 months, and the quality is stable in the long-term 24 months. Therefore, the validity period of this product is at least 24 months.
Embodiment 3
[0077] A levo-oxiracetam granule, prepared according to the following steps:
[0078]
[0079] 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. Prepared finished product is tested by the test method of embodiment 1, and the Hughes angle test measurement result shows that this product granule fluidity is good, and Hughes angle is lower than 33 °, and the loading difference test shows that this product loading difference is less than 5°. %, the loading of this product is stable and controllable. The results of the stability test show that the quality of the sample is stable in the accelerated period of 6 months, and the quality is stable in the long-term 24 months. Therefore, the validity period of this product is at least 24 months.
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