Repaglinide and metformin hydrochloride medicinal composition and its preparation method
A technology for metformin hydrochloride and a composition is applied in the field of pharmaceutical compositions containing repaglinide and metformin hydrochloride and the field of preparation thereof, which can solve the problems of complicated preparation process and high production cost, and achieve good fluidity, low friability, Good tablet hardness
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Example Embodiment
[0047] Embodiment 1-4, tablet
[0048] The pharmaceutical composition of the present invention, the preferred formula composition is as follows: prescription (amount of 1000 tablets, unit: g)
[0049]
[0050] The composition preparation method of the present invention comprises the following steps:
[0051] a) dissolve poloxamer and meglumine in 50% ethanol, add repaglinide, and add povidone after dissolving;
[0052] b) pulverizing metformin hydrochloride through a 60-mesh sieve, and mannitol through a 30-mesh sieve, for subsequent use;
[0053] c) Weigh the recipe quantities of metformin hydrochloride, microcrystalline cellulose, crospovidone, mannitol and polyethylene glycol 6000 and place them in the fluidized bed, and set the inlet air volume to 500±200m 3 / h, the inlet air temperature is 90±5℃, the product temperature is 70±5℃, and hot melt granulation is performed;
[0054] d) spray the repaglinide solution into the fluidized bed, set the atomization pressure to ...
Example Embodiment
[0059] Embodiment 5-6, the tablet of the present invention
[0060]
[0061] The composition preparation method of the present invention comprises the following steps:
[0062] a) dissolve poloxamer and meglumine in 50% ethanol, add repaglinide, and add povidone after dissolving;
[0063] b) pulverizing metformin hydrochloride through a 60-mesh sieve, and mannitol through a 30-mesh sieve, for subsequent use;
[0064] c) Weigh the recipe quantities of metformin hydrochloride, microcrystalline cellulose, crospovidone, mannitol and polyethylene glycol 6000 and place them in the fluidized bed, and set the inlet air volume to 500±200m 3 / h, the inlet air temperature is 90±5℃, the product temperature is 70±5℃, and hot melt granulation is performed;
[0065] d) spray the repaglinide solution into the fluidized bed, set the atomization pressure to 1.0 ± 0.2 bar and the spray speed to 30 ± 10 Hz, and perform one-step granulation;
[0066] e) pass the prepared granules through a 1...
Example Embodiment
[0070] Experimental Example 1. Determination of physical properties of the granules and tablets of the present invention
[0071] Get the granule and tablet of above-mentioned embodiment 1-6, carry out granule fluidity, tablet hardness, friability test
[0072] The measurement results of particle fluidity (angle of repose), bulk density, tapped density, tablet hardness, and friability are shown in the following table:
[0073]
[0074] From the results in the above table, it can be seen that the particle fluidity of Examples 1-6 is not much different, the tablet hardness is suitable, and the friability is small.
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