Simvastatin tablet and preparation method thereof

A technology for simvastatin and tablets, which is applied in the field of simvastatin tablets and its preparation, can solve the problems that the dissolution behavior cannot be simulated, the rationality of the prescription process needs to be studied, and the quality evaluation method needs to be improved.

Active Publication Date: 2015-01-28
DIAO GRP CHENGDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] For Simvastatin Tablets recorded in Part II of the 2010 Edition of the Chinese Pharmacopoeia, pH 7.0 buffer solution was used as the dissolution medium in the quality standard to evaluate the dissolution rate of this product in vitro. That is, disintegration and dissolution wil

Method used

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  • Simvastatin tablet and preparation method thereof
  • Simvastatin tablet and preparation method thereof
  • Simvastatin tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Simvastatin 100g

[0025] Butylated hydroxyanisole 0.05g

[0026] Hypromellose 5.0g

[0027] Proper amount of ethanol

[0028] Appropriate amount of purified water

[0029] Spherical lactose 1000g

[0030] Croscarmellose Sodium 30g

[0031] Silica 8.0g

[0032] Magnesium Stearate 3.0g

[0033] Film coating powder 30.0g

[0034] Preparation:

[0035] Dissolving butylated hydroxyanisole in an appropriate amount of ethanol solution, adding hypromellose to disperse evenly, and adding an appropriate amount of water to prepare a gel-like adhesive. Pour the adhesive into the raw material of simvastatin, stir it into loose and uniform small particles by stirring and granulating, transfer the material to the boiling tower for drying at a temperature lower than 50°C, stop drying when the moisture content of the particles is lower than 2%, and press into tablet. After uniformly suspending the film coating premix with 60% ethanol solution, spray coating evenly until the ...

Embodiment 2

[0037] Simvastatin 100g

[0038] Butylated hydroxyanisole 0.07 g

[0039] Hypromellose 5.0 g

[0040] Proper amount of ethanol

[0041] Appropriate amount of water

[0042] Spherical lactose 2000 g

[0043] Croscarmellose Sodium 50 g

[0044] Silica 15 g

[0045] Magnesium stearate 10 g

[0046] Film Coating Powder 50 g

[0047] Preparation:

[0048] Dissolving butylated hydroxyanisole in an appropriate amount of ethanol solution, adding hypromellose to disperse evenly, and adding an appropriate amount of water to prepare a gel-like adhesive. Pour the adhesive into the raw material of simvastatin, stir it into loose and uniform small particles by stirring and granulating, transfer the material to the boiling tower for drying at a temperature lower than 50°C, stop drying when the moisture content of the particles is lower than 2%, and press into tablet. After uniformly suspending the film coating premix with 60% ethanol solution, spray coating evenly until the tablet...

Embodiment 3

[0050] Simvastatin 100.0 g

[0051] BHA 0.1 g

[0052] Hypromellose 10.0 g

[0053] Proper amount of ethanol

[0054] Appropriate amount of purified water

[0055] Spherical lactose 2000.0 g

[0056] Croscarmellose Sodium 40.0 g

[0057]Silica 10.0 g

[0058] Magnesium stearate 10.0 g

[0059] Film coating powder 50.0 g

[0060] Dissolving butylated hydroxyanisole in an appropriate amount of ethanol solution, adding hypromellose to disperse evenly, and adding an appropriate amount of water to prepare a gel-like adhesive. Pour the adhesive into the raw material of simvastatin, stir and granulate into loose and uniform small particles, transfer the material to the boiling tower for drying at a temperature lower than 50°C, stop drying when the moisture content of the particles is lower than 2%, and press into tablet. After uniformly suspending the film coating premix with 60% ethanol solution, spray coating evenly until the tablet core is evenly covered with a layer of f...

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Abstract

The invention discloses a simvastatin tablet and a preparation method thereof. The simvastatin tablet comprises an active ingredient simvastatin and pharmaceutical excipients, wherein the pharmaceutical excipients are spherical lactose, cross-linked sodium carboxymethyl cellulose, butylhydroxyanisole, hydroxypropyl methyl cellulose, silicon dioxide, magnesium stearate and film coating premix, which are added according to a specific mass ratio and process. The simvastatin and the pharmaceutical excipients are incompatible, and are prone to hydrolysis and oxidation, lactone bonds break to open loop to generate an active metabolite simvastatin hydroxy acid under the high-humidity condition, the intramolecular diene bond is subjected to a slow oxidative copolymerization reaction to generate a dimer or polymer under the high-temperature condition, and the preparation of a stable preparation is greatly difficult. In recent years, with the continuous disclosure of information, the difference between the quality standards of simvastatin tablets produced by different manufacturers is great, wherein the dissolution behavior difference is more significant, so that the situation that the simvastatin tablets have the same name but have different quality is very obvious. The prescription process determined by the study can continuously produce the simvastatin tablet at large scale, and the prepared simvastatin tablet has a good dissolution performance in various PH-value dissolution media, and keeps good stability in the long-term storage process.

Description

technical field [0001] The invention relates to a drug simvastatin, in particular to a simvastatin tablet and a preparation method thereof. Background technique [0002] In recent years, with changes in eating habits, improvements in living standards, and increased work pressure, there are more and more patients with hyperlipidemia and hyperproteinemia, and the patient population is getting younger and younger. With the continuous development of medical science, people realize that the high content of cholesterol and fat is the basic cause of cardiovascular disease, and hyperlipidemia is the main risk factor of coronary heart disease and hypertension. Therefore, people began to focus on the development of blood lipid regulating drugs as the prevention and treatment of cardiovascular diseases. The medical community is full of confidence in the role of lipid-lowering drugs in preventing and treating cardiovascular diseases, and lipid-lowering therapy will become the main meth...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/366A61K47/38A61K47/10A61P3/06A61P9/10
Inventor 简晓娜黄磊
Owner DIAO GRP CHENGDU PHARMA
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