Repaglinide and dimethyldiguanide pharmaceutical composition and preparation method thereof
A technology of metformin hydrochloride and its composition, which is applied in the field of a new pharmaceutical composition and its preparation, can solve the problem that repaglinide is not enough to dissolve at room temperature, and achieve the effect of easy-to-obtain source and simple process
Inactive Publication Date: 2015-07-15
SHANDONG INST OF PHARMA IND
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Problems solved by technology
[0006] Above-mentioned technology mainly has the following defects: 1. Repaglinide is almost insoluble in water, but it needs to be made into a solution state and spray-dried. Although the method of adding alkaline solubilizer meglumine and surfactant poloxamer can improve the However, even if meglumine and poloxamer are added beyond the safe tolerance range of the human body, the solubility of the obtained repaglinide is not enough to dissolve the target amount of repaglinide at room temperature. Repaglinide is heated to 80~90°C to produce a suitable amount of repaglinide solution, and this temperature is maintained before spray drying. great challenge
Method used
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Embodiment 2
[0023] Example 2 Repaglinide Metformin Tablets (Comparative Sample 1)
[0024] Adopt the preparation method in CN101756971 (embodiment 1) to prepare repaglinide metformin tablet, the prescription composition is as follows:
[0025]
Embodiment 3
[0026] Example 3 Repaglinide Metformin Tablets (Comparative Sample 2)
[0027] Adopt the preparation method in CN102319245 (embodiment 2) to prepare repaglinide metformin tablet, the prescription composition is as follows:
[0028]
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The invention belongs to the field of pharmaceutical compositions for treating non-insulin dependent diabetes mellitus (NIDDM), and in particular relates to a novel pharmaceutical composition for repaglinide and dimethyldiguanide tablets and a preparation method thereof. The pharmaceutical composition is equivalent to PrandiMet in dissolving-out characteristic on the basis that good content uniformity of repaglinide is ensured, and related substances are superior to the existing products. The preparation method is suitable for industrialized production.
Description
technical field [0001] The invention belongs to the field of pharmaceutical compositions for treating non-insulin-dependent diabetes mellitus (NIDDM), and specifically relates to a new pharmaceutical composition of repaglinide metformin tablets and a preparation method thereof. Background technique [0002] Repaglinide Metformin Tablets (trade name: PrandiMet) was approved by the FDA in June 2008 and launched in the United States as an auxiliary means of diet control and exercise to improve blood sugar control. Adults with type 2 diabetes whose blood sugar cannot be effectively controlled by meglitinide alone or metformin hydrochloride alone. [0003] Disclosed in CN101516347 is the preparation method of repaglinide and metformin tablets as follows: 1. prepare repaglinide pre-preparation granules containing repaglinide with dissolution characteristics independent of pH value, which contains an appropriate amount of solubilizer, binder , alkaline agent and filler, and contro...
Claims
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IPC IPC(8): A61K31/451A61K47/38A61K47/34A61P3/10A61K31/155
Inventor 张雯刘丽华封静刘晓琰曹冲
Owner SHANDONG INST OF PHARMA IND
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