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Repaglinide tablet and preparation method thereof

A repaglinide tablet, weight percentage technology, applied in the field of pharmaceutical preparations, can solve the problems of difficulty in improving product quality, inability to improve dissolution, poor adhesion and the like

Inactive Publication Date: 2015-03-25
HARBIN PHARMA GROUP TECH CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The inventors have found through research that repaglinide raw materials have poor adhesion, but the degree of micronization is relatively high. The use of wet granulation can solve the problem of poor adhesion, but it is difficult to make full use of the advantages of its micronization, especially conventional adhesion. The use of the agent, the dissolution rate cannot be improved, and it is difficult to improve the product quality. For this reason, the inventor has carried out research on the adhesive, and unexpectedly found that using meglumine, poloxamer, and povidone to form a Composite binder granulation can achieve more than 80% dissolution in 30 minutes, which solves the problems existing in the prior art

Method used

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

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Experimental program
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Effect test

Embodiment 1

[0074] The weight percentage of each component of the tablet consists of: repaglinide 1%, microcrystalline cellulose 49%, calcium hydrogen phosphate 25%, pregelatinized starch 10%, croscarmellose sodium 5.5%, polyvinyl chloride Ketone 5%, Poloxamer 188 (F68) 1.5%, Meglumine 2%, Magnesium Stearate 0.5%, Yellow Iron Oxide 0.25%, Red Iron Oxide 0.25%.

[0075] Preparation method, the steps are as follows:

[0076] 1) Pass the raw material and auxiliary materials microcrystalline cellulose, calcium hydrogen phosphate, pregelatinized starch, croscarmellose sodium, magnesium stearate, coloring agent, etc. through a 60-mesh sieve, and set aside.

[0077] 2) Mix the coloring agent with croscarmellose sodium, repaglinide raw material and pregelatinized starch; after mixing, add calcium hydrogen phosphate and 1 / 3 of microcrystalline cellulose and mix in a three-dimensional motion mixer After 5 to 10 minutes, put the rest of the microcrystalline cellulose in the prescribed amount into a...

Embodiment 2

[0082] Repaglinide 1%, microcrystalline cellulose 51.5%, calcium hydrogen phosphate 25%, pregelatinized starch 10%, croscarmellose sodium 5%, povidone 3%, poloxamer 188 ( F68) 1.5%, meglumine 2%, magnesium stearate 0.5%, yellow iron oxide 0.25%, red iron oxide 0.25%.

[0083] Preparation method, the steps are as follows:

[0084] 1) Pass the raw material and auxiliary materials microcrystalline cellulose, calcium hydrogen phosphate, pregelatinized starch, croscarmellose sodium, magnesium stearate, coloring agent, etc. through a 60-mesh sieve, and set aside.

[0085] 2) Mix the coloring agent with croscarmellose sodium, repaglinide raw material and pregelatinized starch; after mixing, add calcium hydrogen phosphate and 1 / 3 of microcrystalline cellulose and mix in a three-dimensional motion mixer After 5 to 10 minutes, put the rest of the microcrystalline cellulose in the prescribed amount into a three-dimensional motion mixer and mix for 30 minutes.

[0086] 3) Take the presc...

Embodiment 3

[0090] Repaglinide 2%, microcrystalline cellulose 50.5%, calcium hydrogen phosphate 25%, pregelatinized starch 10%, croscarmellose sodium 5%, povidone 3%, poloxamer 188 ( F68) 1.5%, meglumine 2%, magnesium stearate 0.5%, yellow iron oxide 0.25%, red iron oxide 0.25%.

[0091] Preparation method, the steps are as follows:

[0092] 1) Pass the raw material and auxiliary materials microcrystalline cellulose, calcium hydrogen phosphate, pregelatinized starch, croscarmellose sodium, magnesium stearate, coloring agent, etc. through a 60-mesh sieve, and set aside.

[0093] 2) Mix the coloring agent with croscarmellose sodium, repaglinide raw material and pregelatinized starch; after mixing, add calcium hydrogen phosphate and 1 / 3 of microcrystalline cellulose and mix in a three-dimensional motion mixer After 5 to 10 minutes, put the rest of the microcrystalline cellulose in the prescribed amount into a three-dimensional motion mixer and mix for 30 minutes.

[0094] 3) Take the presc...

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Abstract

The invention relates to a repaglinide tablet and a preparation method thereof. According to the preparation method, a wet granulation process is used, calcium hydrophosphate, microcrystalline cellulose and pregelatinized starch are used as filling agents, and meglumine, poloxamer and povidone are matched to prepare a binder to carry out wet granulation, so that the prepared repaglinide tablet is uniform in content and favorable to release; compared with the prior art, the wet granulation process is capable of solving the problems of non-uniform content and low dissolution rate in the preparation process; and meanwhile, the dissolution rate and the stability of the prepared preparation are consistent with those of the original contrast drug so that the drug quality is ensured.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a repaglinide tablet and a preparation method thereof. Background technique [0002] Drug therapy is the main method of diabetes treatment, mainly including oral hypoglycemic drug therapy and insulin therapy. Among them, chemical drugs play a dominant role in oral hypoglycemic drugs, mainly including: sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, and insulin secretagogues. [0003] Repaglinide is a derivative of aminoacetylbenzoic acid. This product specifically binds to the 36KDA protein on the ATP-dependent potassium ion channel outside the islet β cell membrane, closing the potassium channel, opening the calcium channel, and influx of calcium ions. , is a novel insulin secretagogue known as a "dietary glucose regulator". [0004] It is mainly used for patients with type 2 diabetes (non-insulin dependent) whose hyperglycemia ca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/451A61K47/04A61K47/36A61K47/38A61K47/10A61K47/32A61P5/50A61P3/10
Inventor 袁淑杰杨新春徐岩李郑武王忠李金花刘磊朱红杰赵金龙
Owner HARBIN PHARMA GROUP TECH CENT
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