Atorvastatin calcium tablets and preparation method thereof

Abstract

The invention relates to atorvastatin calcium tablets and a preparation method thereof. The tablets comprise the following components in parts by weight: 1 part of atorvastatin calcium (in terms of atorvastatin), 1 part of croscarmellose sodium, 15 parts of lactose (80M), and 0.2 part of magnesium stearate. The preparation method comprises the following steps: screening the atorvastatin calcium and the croscarmellose sodium based on the amounts of the formula through a 120-meshed sieve respectively, and mixing uniformly; uniformly mixing the mixture with the lactose based on the amount of the formula according to a uniform progressive increasing method; and uniformly mixing the magnesium stearate based on the amount of the formula, and tabletting. The tablets have the advantages of stable quality, controllable related substances, good dispersibility and high dissolution speed.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and relates to an atorvastatin calcium dispersible tablet and a preparation method thereof, in particular to an atorvastatin calcium dispersible tablet and a preparation method thereof. Background technique [0002] The chemical name of atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3- Phenyl-4-[(anilino)carbonyl]-1H-pyrrole-1-heptanoic acid calcium salt (2∶1) trihydrate, a statin hypolipidemic agent, can effectively reduce homozygous and heterozygous familial high The plasma total cholesterol, low-density lipoprotein cholesterol, apolipoprotein and triglyceride levels in patients with cholesterolemia, non-familial cholesterolemia, and mixed lipid metabolism disorders, while increasing high-density lipoprotein cholesterol and load to varying degrees Lipoprotein A 1 Level. [0003] The currently marketed atorvastatin calcium tablets (reference example 1) are pr...

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Problems solved by technology

[0003] Currently listed atorvastatin calcium tablets (reference example 1) are prepared by wet granulation, because atorvastatin calcium has poor moisture and heat stability, and alkaline environment can play a stabilizing effect (Chinese patent CN1630510A ), so calcium carbonate is added as a stabilizer in the prescription, which is also the main cause of adverse reactions such as constipation, flatulence, indigestion and abdominal pain caused by reference example 1

[0004] Chinese patent CN1911209A discloses a rapidly disintegrating atorvastatin calcium tablet and a preparation method thereof. The atorvastatin calcium tablet is prepared by wet granulation. A large amount of disintegrants are used in the formula, and the disadvantage lies in the preparation process. Torvastatin calcium is unstable and will produce more related substances. The related substances increase relatively quickly during long-term storage at room temperature, and the product is not stable enough. In addition, its process is complicated, the production cycle is long, and the cost is high.

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