Pharmaceutical composition containing vildagliptin and metformin and preparation method of pharmaceutical composition
A composition and drug technology, applied in the field of pharmaceutical preparations, can solve the problems of unfavorable scale-up production, complicated process, expensive price, etc., and achieve the effects of easy operation, simple process and stable product quality
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preparation example Construction
[0032] In the preparation method of the embodiment, the name, model and purchaser of the main instrument need to be used, as shown in the following table:
[0033] device name model Manufacturer Granulating Coating Machine DP-II Chongqing Jinggong Pharmaceutical Machinery Co., Ltd. Down drive crushing and granulating machine U5 Canada QUADRO Machinery Company Hopper mixer JGSD-15 Chongqing Jinggong Pharmaceutical Machinery Co., Ltd. Laboratory dry press granulator LGY-120 Beijing Sinopharm Longli Automation Technology Co., Ltd. Rotary Tablet Press ZP8S Shanghai Tianxiang Jiantai Pharmaceutical Machinery Co., Ltd. Coating machine Labcoat M O'HARA Technologies Inc
Embodiment 1
[0034] Embodiment 1: Metformin Vildagliptin Tablet Oral Preparation Prescription and Process
[0035] prescription:
[0036]
[0037] Note: * will be removed during processing.
[0038] Preparation Process:
[0039] (1) Preparation of metformin hydrochloride granules:
[0040] Preparation of binder aqueous solution: prepare a certain concentration of binder and stir until the solution is clear;
[0041] Fluidized bed granulation: put the material metformin hydrochloride in the fluidized bed, set the inlet air temperature at 50°C, start spraying the binder solution when the material temperature reaches 35-45°C, and then dry the obtained granules in the fluidized bed , control particle moisture below 2.0%;
[0042] Dry granulation: Use a 1.0mm sieve for granulation.
[0043] (2) Non-lubricating mixing: add about 1 / 2 metformin hydrochloride granules, vildagliptin, lactose and the remaining 1 / 2 metformin hydrochloride granules to the hopper mixer in sequence, set the param...
Embodiment 2
[0048] Example 2: Metformin Vildagliptin Tablet Oral Preparation Prescription and Process
[0049] prescription:
[0050]
[0051] Note: * will be removed during processing.
[0052] Preparation Process:
[0053] (1) Preparation of metformin hydrochloride granules:
[0054] Preparation of binder aqueous solution: prepare a certain concentration of binder and stir until the solution is clear;
[0055] Fluidized bed granulation: put the material metformin hydrochloride in the fluidized bed, set the inlet air temperature at 50°C, start spraying the binder solution when the material temperature reaches 35-45°C, and then dry the obtained granules in the fluidized bed , control particle moisture below 2.0%;
[0056] Grain sizing: Use a 1.0mm sieve for sizing.
[0057] (2) Non-lubricating mixing: add about 1 / 2 metformin hydrochloride granules, vildagliptin, lactose and the remaining 1 / 2 metformin hydrochloride granules into the hopper mixer in sequence, set the parameters at 15...
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