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Preparation method of pharmaceutical composition containing repaglinide and metformin hydrochloride
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A technology for metformin hydrochloride and a composition, which is applied in the field of preparation of pharmaceutical compositions, can solve the problems of large specification of metformin hydrochloride, difficult to guarantee uniformity, small specification of repaglinide, etc., achieves good fluidity, improved poor compressibility, Process stability effect
Active Publication Date: 2016-05-11
CHINA RESOURCES SAIKE PHARMA
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[0007] The purpose of the present invention is to provide a preparation method of a pharmaceutical composition containing repaglinide and metformin hydrochloride, and at the same time solve the problem that metformin hydrochloride has a large specification and poor compressibility, and repaglinide has a small specification and difficult to ensure uniformity , low solubility and poor dissolution
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[0022] 2) Grind metformin hydrochloride and sieve it for later use;
[0023] 3) Weigh the formulated amount of metformin hydrochloride, microcrystallinecellulose PH101, crospovidone XL-10 and polyethylene glycol 6000, and place them in a high-shear mixing granulator to mix evenly;
[0024] 4) Add the mixed solution obtained in step 1) into a high-shear granulator, stir evenly to make soft material, pass through a 2mm screen and use a lifting granulator to granulate, mix evenly and place it in a fluidized bed to dry, set the material temperature 60°C;
[0025] 5) Spray the prepared povidone K30 solution into the fluidized bed, set the parameters of atomization pressure and spray speed for one-step granulation, and set the material temperature to 60°C;
[0026] 6) Mix the prepared granules with cros...
Embodiment 2
[0028] Example 2 (quantity of 1000 pieces, unit: g)
[0032] 2) Grind metformin hydrochloride and sieve it for later use;
[0033] 3) Weigh the formulated amount of metformin hydrochloride, microcrystallinecellulose PH101, crospovidone XL-10 and polyethylene glycol 6000, and place them in a high-shear mixing granulator to mix evenly;
[0034] 4) Add the mixed solution obtained in step 1) into a high-shear granulator, stir evenly to make soft material, pass through a 2mm screen and use a lifting granulator to granulate, mix evenly and place it in a fluidized bed to dry, set the material temperature 60°C;
[0035] 5) Spray the prepared povidone K30 solution into the fluidized bed, set the parameters of atomization pressure and spray speed for one-step granulation, and set the material temperature to 60°C;
[0036] 6) Mix the prepar...
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Abstract
The present invention provides a preparation method of a pharmaceutical composition comprising active ingredients repaglinide and metforminhydrochloride, the pharmaceutical composition contains repaglinide, metforminhydrochloride and pharmaceutically acceptable excipients, the preparation method The method comprises the following steps: uniformly mixing repaglinide and metformin through a high-shear mixing granulator; and directly spraying the binder solution into the composition of repaglinide and metformin to granulate through a one-step granulation technology, and then adding Some excipients are prepared into tablets. Beneficial effects of the present invention: the present invention can ensure that repaglinide has better uniformity and dissolution rate not affected by pH value, meanwhile, the problem of poor compressibility of metformin hydrochloride is improved, the process is stable, the particles are uniform, and the fluidity is good. Solved the problem of mixing uniformity and dissolution of low-grade repaglinide and high-grade metformin.
Description
technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a preparation method of a pharmaceutical composition containing repaglinide and metformin hydrochloride. Background technique [0002] RepaglinideMetformin HCl Tablets (PrandiMet) is a drug developed by Novo Nordisk for the treatment of type 2 diabetes, which was officially approved by the US FDA in July 2008. The dosage specifications are repaglinide / metformin hydrochloride 1mg / 500mg and 2mg / 500mg. PrandiMet combines two drugs with different mechanisms of action to improve blood sugar control in people with type 2 diabetes. Repaglinide specifically binds to the KDA protein on the ATP-dependent potassiumion channel outside the islet β cell membrane, closing the potassium channel, depolarizing the β cell, opening the calcium channel, opening the calciumion influx, promoting insulinsecretion, and its action is faster than that of sulfonylureas. The postprandial ...
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