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Preparation method of atorvastatin calcium preparation

A technology of atorvastatin calcium and preparations, which is applied in the field of preparation of blood lipid-lowering preparations, and can solve problems affecting bioavailability, etc.

Active Publication Date: 2015-06-10
BEIJING WINSUNNY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The present inventor has developed a kind of preparation method of atorvastatin calcium preparation through a large number of tests, and this method can well solve the problem that alkaline earth metal salt influences the bioavailability of atorvastatin calcium preparation, makes atorvastatin calcium The preparation has good stability, bioavailability and dissolution rate

Method used

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  • Preparation method of atorvastatin calcium preparation
  • Preparation method of atorvastatin calcium preparation
  • Preparation method of atorvastatin calcium preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] (1) Mix 10.824g of atorvastatin calcium (equivalent to 10g of atorvastatin) with 50g of lactose and 40g of calcium carbonate in equal amounts, crush and sieve to obtain mixed powder a;

[0032] (2) Mix the obtained mixed powder a with 10 g of sodium carboxymethyl starch and 5 g of micropowder silica gel evenly to obtain mixed powder b;

[0033] (3) Dissolve 2 g of povidone in 60 mL of ethanol to obtain povidone ethanol solution;

[0034] (4) Add the ethanol solution of povidone into the mixed powder b for wet granulation;

[0035] (5) Add 30g of microcrystalline cellulose, mix well, press into tablets, and coat with film.

Embodiment 2

[0037] (1) Mix 10.824g of atorvastatin calcium (equivalent to 10g of atorvastatin) with 60g of mannitol and 45g of sodium carbonate in equal amounts, crush and sieve to obtain mixed powder a;

[0038] (2) Mix the obtained mixed powder a with 10 g of crospovidone, 5 g of sodium carboxymethyl starch, and 6 g of micronized silica gel to obtain mixed powder b;

[0039] (3) Dissolve 4g of hypromellose in 120mL of ethanol to obtain hypromellose ethanol solution;

[0040] (4) Add the hypromellose ethanol solution to the mixed powder b for wet granulation;

[0041] (5) Add 40g of microcrystalline cellulose, mix well, press into tablets, and coat with film.

Embodiment 3

[0043] (1) Mix 16.236g of atorvastatin calcium (equivalent to 15g of atorvastatin) with 52g of sorbitol and 38g of sodium bicarbonate in equal amounts, grind and sieve to obtain mixed powder a;

[0044] (2) Mix the obtained mixed powder a with 18g of croscarmellose sodium and 4.5g of micropowder silica gel evenly to obtain mixed powder b;

[0045] (3) Dissolve 3 g of povidone in 80 mL of ethanol to obtain povidone ethanol solution;

[0046] (4) Add the ethanol solution of povidone into the mixed powder b for wet granulation;

[0047] (5) Add 37g of microcrystalline cellulose and 0.5g of magnesium stearate, mix well, press into tablets, and coat with film.

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Abstract

The invention relates to a preparation method of an atorvastatin calcium preparation. According to the method, atorvastatin calcium is mixed with a hydrophilic diluent and an alkali diluent in an equal increment way, and then mixed with a disintegrating agent and aerosil; an adhesive is added into the mixture; ethanol solution wet granulation is carried out; and then microcrystalline cellulose is added; and tabletting and film coating are carried out to obtain the preparation. The method can well solve the problem of influence of alkaline earth metal salt on bioavailability of atorvastatin calcium preparation, so as to realize good stability, bioavailability and dissolution rate of atorvastatin calcium preparation.

Description

[0001] technical field [0002] The invention relates to a preparation method of a blood lipid-lowering preparation, in particular to a preparation method of an atorvastatin calcium preparation. Background technique [0003] Hyperlipidemia is a systemic disease that refers to excessively high total cholesterol and / or triglycerides or low high-density lipoprotein cholesterol in the blood. Long-term untreated hyperlipidemia can lead to cardiovascular diseases such as atherosclerosis, coronary heart disease, myocardial infarction, and hypertension. These cardiovascular diseases have a high incidence, great harm, and dangerous disease progression. about half of . Therefore, further research on blood lipid-lowering preparations is of great significance to ensure safe and effective medication for patients. [0004] Atorvastatin calcium was developed by Pfizer with the chemical name [R-(R,R)]-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl) -3-Phenyl-4-[(aniline)carbonyl]-1hyd...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/40A61P3/06A61P9/10A61J3/00
Inventor 产运霞耿玉先王彩平
Owner BEIJING WINSUNNY PHARMA CO LTD
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