Simvastatin tablet and preparation method thereof

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...

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 will occur, and pH7.0 buffer solution cannot simulate the dissolution behavior of this product in vivo

Although simvastatin tablets have been on the market for many years, the quality evaluation method needs to be improved, and the rationality of the prescription process needs to be studied

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