Favipiravir granular preparation and preparation method therefor
A technology of lavir granules and granule preparations, which is applied in the field of medicine and can solve the problems of difficult swallowing of tablets and the like
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Embodiment 1~4
[0057] The used prescription and prescription consumption of embodiment 1-4 are as shown in table 1 below:
[0058] Table 1
[0059] Component classification name Example 1 Example 2 Example 3 Example 4 parts by weight parts by weight parts by weight parts by weight Main drug Favipiravir 200 200 200 200 filler dextrin 0 200 500 100 suspending agent Tragacanth Gum 10 50 100 150 sweetener sucrose 2000 1300 800 0 sweetener aspartame 0 20 40 80 pH regulator citric acid 1 50 70 120 pH regulator Sodium citrate 10 75 30 20 Glidant Micropowder silica gel 50 50 50 20 Batch / gram 300 300 300 300 Main drug particle size / micron 9.4 38 29 12 Granule formulation pH 5.8 4.9 3.5 2.3 Sedimentation volume ratio 0.91 0.94 0.95 0.96 Taste score 3.1 points 3.7 points 4.3 points 3.5 points
[0060] From the above resu...
Embodiment 1
[0061] Embodiment 1 preparation process steps:
[0062] 1) Favipiravir is subjected to airflow pulverization, the materials are collected, the particle size distribution is measured and controlled, and the D90 is obtained as a bulk drug of 9.4 microns;
[0063] 2) Pass tragacanth gum, sucrose, and micropowdered silica gel through a 60-mesh sieve respectively, and set aside;
[0064] 3) Mix the materials of step 1) and step 2) together in a mixer for 20 minutes to obtain the favipiravir granule formulation.
Embodiment 2~4
[0065] Embodiment 2~4 preparation process steps:
[0066] 1) Favipiravir is subjected to airflow pulverization, the material is collected, and the particle size distribution D90 is measured and controlled to be less than 40 microns;
[0067] 2) Pass the components other than the bulk drug through a 40-mesh sieve respectively, and set aside;
[0068] 3) Mix the other materials except micropowder silica gel and aspartame in step 1) and step 2) in a high-shear granulator, and then add the solution prepared by aspartame and purified water and continue stirring. Get the soft material with suitable wetting degree;
[0069] 4) the soft material of step 3) is carried out wet granulation by using a swing granulator with 40 meshes;
[0070] 5) The material obtained in step 4) is dried, and the obtained dried granules are dry granulated using a 40-mesh screen with an aperture;
[0071] 6) Mix the glidant and the granules obtained in step 5 in a mixer for 10 minutes to obtain the favip...
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