Repaglinide tablet and preparation method thereof

A technology for repaglinide tablets and tablets, applied in the field of pharmaceutical manufacturing, can solve problems such as adverse reactions, and achieve the effects of improving solubility and improving curative effect

Inactive Publication Date: 2012-10-24
NANJING ZENKOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] 4. Adverse reactions
In foreign countries, polacrilin potassium and repaglinide are used for compatibility, and the complexation between polacrilin potassium and repaglinide molecules is used to increase the stability of repaglinide; domestically, control of production and storage conditions is used to delay Degradation of repaglinide, but both methods failed to fundamentally solve the problem of repaglinide degradation

Method used

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  • Repaglinide tablet and preparation method thereof
  • Repaglinide tablet and preparation method thereof
  • Repaglinide tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] prescription:

[0027]

[0028] Preparation method: Mix repaglinide, ethyl oleate, polyoxyethylene hydrogenated castor oil, and polyethylene glycol 4000 evenly, heat to 60°C and stir to dissolve into a solution, add starch, stir evenly, dry at 60°C for 2 hours, and pulverize Pass through an 80 mesh sieve and use it as the intermediate (1) for later use; weigh the microcrystalline cellulose of the prescription amount and mix it with the intermediate (1) evenly, dry-process 20 mesh granulation, 18 mesh granulation, add the prescription amount of cross-linked carboxyl Sodium methylcellulose and magnesium stearate are uniformly mixed and compressed into tablets with a hardness of 5-8kg.

Embodiment 2

[0030] prescription:

[0031]

[0032] Preparation method: Mix repaglinide, ethyl oleate, polyethylene glycol 15 hydroxystearate, meglumine, polyethylene glycol 6000 evenly, heat to 60°C and stir to dissolve into a solution, add calcium hydrogen phosphate, Stir evenly, dry at 60°C for 2 hours, pulverize through an 80-mesh sieve, and use it as an intermediate (1) for later use; weigh the prescribed amount of microcrystalline cellulose and mix it evenly with the intermediate (1), dry-process 20-mesh granulation, 18-mesh Whole grain, add the prescription amount of sodium carboxymethyl starch and magnesium stearate, mix evenly, and compress into a tablet with a hardness of 5-8kg.

Embodiment 3

[0033] Example 3: Dissolution testing and long-term stability investigations were performed on the repaglinide tablets prepared in Example 1 and Example 2 and commercially available repaglinide tablets (Novoron).

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Abstract

The invention discloses a repaglinide tablet and a preparation method thereof, belonging to the new technical field of medicines. The repaglinide tablet mainly contains repaglinide and is prepared by a solid self-emulsifying technology, wherein the tablet further contains a diluent, an emulsifier, an assistant emulsifier, an adsorbent, filler, a disintegrating agent and a lubricant. The repaglinide tablet overcomes the instability of repaglinide, has the advantages of improved dissolution rate of repaglinide and enhanced treatment effect and has ideal treatment effect.

Description

technical field [0001] The invention belongs to the field of pharmaceutical manufacturing, and relates to a new technology of repaglinide, in particular to a repaglinide tablet and a preparation method thereof. Background technique [0002] Repaglinide is a non-sulfonylurea hypoglycemic drug, which was first developed by Boehringer Ingelheim and authorized to Novo Nordisk in 1990. 1997 Approved by the FDA for the treatment of type 2 diabetes [0003] 1. Pharmacology and Toxicology [0004] This product specifically binds to the 36KDA protein on the ATP-dependent potassium ion channel outside the islet β cell membrane, closes the potassium channel, depolarizes the β cell, opens the calcium channel, and promotes the influx of calcium ions to promote insulin secretion. ureides, so the postprandial hypoglycemic effect is faster. [0005] 2. Pharmacokinetics [0006] Repaglinide tablets are rapidly absorbed through the gastrointestinal tract, leading to a rapid increase in pl...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/451A61P3/10
Inventor 徐卓业
Owner NANJING ZENKOM PHARMA
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