Stable repaglinide pharmaceutical composition and preparation method thereof

A composition and drug technology, applied in the field of solid preparations, can solve the problems of reduced uniformity of preparation content, different particle sizes, sticky materials, etc., and achieve the effects of improving mixing uniformity, controllable production process, and product quality assurance

Active Publication Date: 2019-02-26
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Compared with wet granulation, this method improves the content of related substances in the repaglinide pharmaceutical preparation, but the dissolution of the preparation has not been improved, and dry granulation is likely to cause stickiness of the material, which reduces the content uniformity of the preparation and causes granulation. different sizes

Method used

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  • Stable repaglinide pharmaceutical composition and preparation method thereof
  • Stable repaglinide pharmaceutical composition and preparation method thereof
  • Stable repaglinide pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] prescription:

[0040]

[0041] Take the material according to the above prescription, mix the active substance, sodium lauryl sulfate and meglumine evenly and pulverize it, then mix it with microcrystalline cellulose and carry out dry granulation, then add crospovidone and magnesium stearate Mix to obtain the final mixture.

[0042] The A-D production process is smooth and the product quality is good. The particle results are shown in Table 1 below.

[0043] Table 1 Example 1 experiment related results

[0044]

[0045] Note: The particle content in this article refers to the measured value / theoretical value of the weight percentage of API in the composition in this field. The theoretical value is also called the labeled amount, and it is usually based on the proportion of API in the formulation design.

[0046] From the above data, it can be seen that sodium lauryl sulfate acts as a lubricant during the dry granulation process, so sodium lauryl sulfate in the...

Embodiment 2

2

[0054] Take the material according to the above prescription, mix the active substance, sodium lauryl sulfate and meglumine evenly and pulverize it, then mix it with microcrystalline cellulose and carry out dry granulation, then add crospovidone and magnesium stearate Mix to obtain the final mixture. Tablet compression was performed to determine the dissolution rate.

[0055] Meanwhile, above-mentioned prescription K is carried out as follows preparation:

[0056] Take the material according to the above K prescription, mix the active substance, sodium lauryl sulfate, meglumine, and crospovidone evenly and pulverize it, then mix it with microcrystalline cellulose and perform dry granulation, and then add stearic acid Magnesium is mixed to obtain the final mixture, which is the "K-1 prescription". Tablet compression was performed to determine the dissolution rate.

[0057] The above-mentioned obtained granules are compressed into tablets, and the results of the dis...

Embodiment 3

[0064] In order to more clearly illustrate the advantages of the prescription and process of this patent, the comparison of wet granulation and dry granulation prescription process is as follows:

[0065] prescription:

[0066] combination

M

N

components

Weight / mg

Weight / mg

active substance

10

10

microcrystalline cellulose

90

91

Sodium dodecyl sulfate

0.7

0.7

meglumine

5

5

Crospovidone

5

5

Magnesium stearate

3

3

[0067] Preparation Process:

[0068] 1. The above composition M was prepared into granules according to the process of Example 1, and pressed into tablets;

[0069] 2. The active substance, microcrystalline cellulose, sodium lauryl sulfate, meglumine, and crospovidone in the above composition N are subjected to pure water wet granulation, dried, and granulated with magnesium stearate mixed, compressed into tablets;

[0070] The above-mentioned prescriptio...

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PUM

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Abstract

The invention relates to a stable repaglinide drug composition and a preparation method thereof. The composition is prepared from an active material S(+)-2-ethyoxyl-4-{2-[(3-methyl-1(2-(1-piperidyl) phenyl) butyl) amino]-2-oxo ethyl}benzoic acid, a surfactant, a stabilizer, a carrier, a disintegrating agent and a lubricant. The invention also discloses a solid preparation prepared from the composition. The preparation is uniform in content uniformity, quick in dissolution and good in stability, realizes consistent dissolution in various dissolution media, and is controllable in product production process, thus comprehensively ensuring end product quality.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a stable pharmaceutical composition and a solid preparation prepared therefrom. Background technique [0002] The incidence of diabetes is increasing year by year. China has become the hardest hit area of ​​the disease, the number of diabetic patients ranks second in the world, and the proportion of type II diabetes has almost reached 100%. [0003] Repaglinide is a non-sulfonylurea insulin-stimulating agent. This product binds to specific receptors on the islet β-cell membrane, closes the ATP-sensitive potassium channel, inhibits the outflow of potassium ions, and causes cell membrane depolarization, resulting in Extracellular calcium ions flow into the cell through voltage-dependent calcium channels, and the intracellular calcium ion concentration increases, stimulating insulin secretion. Its action is faster than that of sulfonylureas. This product is mainly used for patients with ty...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/18A61K31/451A61K9/20A61P3/10
CPCA61K9/2027A61K31/451A61K47/18
Inventor 拥青她姆陈中亚周炳城
Owner JIANGSU HANSOH PHARMA CO LTD
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