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Antidiabetic pharmaceutical composition and preparation method thereof

A composition and drug technology, applied in anti-diabetic pharmaceutical composition, pharmaceutical composition containing DPP-4 inhibitor and metformin hydrochloride and its preparation field, can solve problems affecting the stability of pharmaceutical composition, etc.

Inactive Publication Date: 2015-08-19
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The inventors found that DPP-4 inhibitors (especially linagliptin) and metformin hydrochloride or various preparation auxiliary materials (such as lactose, microcrystalline cellulose, etc.) Impurity reactions are prone to occur, which seriously affects the stability of the pharmaceutical composition

Method used

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  • Antidiabetic pharmaceutical composition and preparation method thereof
  • Antidiabetic pharmaceutical composition and preparation method thereof
  • Antidiabetic pharmaceutical composition and preparation method thereof

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Experimental program
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specific Embodiment approach

[0057] In order to enable those skilled in the art to better understand the technical solutions of the present invention, some non-limiting examples are further disclosed below to further describe the present invention in detail.

[0058] The reagents used in the present invention can be purchased from the market or can be prepared by the methods described in the present invention.

[0059] In the present invention, min means minute, mg means milligram, and LOD means loss on drying.

Embodiment 1

[0061] prescription composition

[0062]

[0063] Preparation:

[0064] 1) Preparation of the first granule: add the prescribed amount of linagliptin, meglumine and polyvinylpyrrolidone to water to prepare a mixed solution containing the binder, use a fluidized bed for granulation, and set the inlet air temperature at 50°C to 60°C ℃, the material temperature is 37 ℃, the air volume of the fan is adjusted according to the fluidization state of the material; after the inlet air temperature reaches the set value, add the pre-mixed mannitol and corn starch and preheat for 5-10 minutes, and start spraying the adhesive solution , the loss on drying (LOD) of the dried particles after spraying is 2.0% to 3%;

[0065] 2) Prepare the second granule: Add the prescribed amount of polyvinylpyrrolidone into water to prepare a binder solution, use a fluidized bed to granulate, set the inlet air temperature at 45°C to 55°C, and the material temperature at 34°C. The air volume of the fan d...

Embodiment 2

[0070] prescription composition

[0071]

[0072] Preparation:

[0073] 1) Preparation of the first granule: add the prescribed amount of linagliptin, meglumine and polyvinylpyrrolidone to water to prepare a mixed solution containing the binder, use a fluidized bed for granulation, and set the inlet air temperature at 50°C to 60°C ℃, the material temperature is 37 ℃, the air volume of the fan is adjusted according to the fluidization state of the material; after the inlet air temperature reaches the set value, add the pre-mixed pregelatinized starch and microcrystalline cellulose and preheat for 5-10 minutes, start Spray the binder solution, and the loss on drying (LOD) of the dried particles after spraying is 2.0% to 3%;

[0074] 2) Prepare the second granule: Add the prescribed amount of polyvinylpyrrolidone into water to prepare a binder solution, use a fluidized bed to granulate, set the inlet air temperature at 45°C to 55°C, and the material temperature at 34°C. The a...

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Abstract

The invention relates to an antidiabetic pharmaceutical composition, more specifically to a pharmaceutical composition containing a DPP-4 inhibitor and metformin hydrochloride and a preparation method thereof. The composition contains DPP-4 inhibitor and metformin hydrochloride two active components, and meglumine as the stabilizer. The pharmaceutical composition has excellent storage stability and excellent dissolution characteristics. The invention also provides a preparation method of the composition, the auxiliary materials of the preparation technology are easily available and low in price, thus being suitable for industrial production.

Description

technical field [0001] The invention relates to an anti-diabetic pharmaceutical composition, more specifically to a pharmaceutical composition comprising a DPP-4 inhibitor and metformin hydrochloride and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Diabetes mellitus is a chronic disease with multiple pathological manifestations, accompanied by disorders of lipid metabolism, circulation and glucose metabolism. As a result, diabetes is prone to develop multiple complications in many cases. Therefore, it is necessary to select the drug suitable for the dominant disease stage for each individual's condition. However, this option is often difficult to implement clinically, because single use of a drug cannot produce sufficient efficacy in certain disease states, and increasing the dose or taking the drug for a long time will bring various side effects such as side effects. question. [0003] Both d...

Claims

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Application Information

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IPC IPC(8): A61K45/00A61K31/155A61K47/18A61P3/10
Inventor 黄启彪詹振库赵锋
Owner SUNSHINE LAKE PHARM CO LTD
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