Atorvastatin calcium tablet and preparation process thereof

A technology of atorvastatin calcium and fillers, which is applied in the field of atorvastatin calcium tablets and its preparation process, can solve the problems of unfavorable quality control, large difference in tablet weight, non-uniform distribution of coating film, etc., and achieve coating effect The effects of stability, small difference in tablet weight, and uniform film thickness

Pending Publication Date: 2022-04-26
HAINAN HAILING CHEMIPHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the existing method, during the preparation process of atorvastatin calcium tablets, the coating film tends to be non-uniformly distributed on the surface of the tablet core, resulting in large differences in tablet weight, which is not conducive to quality control

Method used

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  • Atorvastatin calcium tablet and preparation process thereof
  • Atorvastatin calcium tablet and preparation process thereof
  • Atorvastatin calcium tablet and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] An atorvastatin calcium tablet is composed of a core material and a coating film. The core material comprises the following raw materials in parts by weight: 10 parts of atorvastatin calcium, 20 parts of filler, 5 parts of binder, disintegrated 12 parts of lubricant, 3 parts of lubricant; the film is made of hydroxypropyl methylcellulose, nano-titanium dioxide and polyvinylpyrrolidone according to the mass ratio of 3:16:1.

[0029] The above filler is a mixture of erythritol and hydroxypropyl-β-cyclodextrin in a mass ratio of 7:3.

[0030] The above binder is a mixture of hydroxypropyl cellulose and povidone K30 in a mass ratio of 4:1.

[0031] The above-mentioned disintegrant is a mixture of microcrystalline cellulose and croscarmellose sodium in a mass ratio of 9:1.

[0032] The aforementioned lubricant is a mixture of magnesium stearate, talc and silicon dioxide in a mass ratio of 1:1:1.

[0033] The preparation technology of above-mentioned atorvastatin calcium ta...

Embodiment 2

[0039] An atorvastatin calcium tablet is composed of a core material and a coating film. The core material comprises the following raw materials in parts by weight: 10 parts of atorvastatin calcium, 15 parts of filler, 5 parts of binder, disintegrated 8 parts of lubricant and 5 parts of lubricant; the film is made of hydroxypropyl methylcellulose, nano-titanium dioxide and polyvinylpyrrolidone according to the mass ratio of 2:18:1;

[0040] The above filler is a mixture of erythritol and hydroxypropyl-β-cyclodextrin in a mass ratio of 7:3.

[0041] The above binder is a mixture of hydroxypropyl cellulose and povidone K30 in a mass ratio of 4:1.

[0042] The above-mentioned disintegrant is a mixture of microcrystalline cellulose and croscarmellose sodium in a mass ratio of 9:1.

[0043] Above-mentioned lubricant is micropowder silica gel.

[0044] The preparation technology of above-mentioned atorvastatin calcium tablet, comprises the following steps:

[0045] 1) According t...

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Abstract

The invention provides an atorvastatin calcium tablet and a preparation process thereof, the atorvastatin calcium tablet is composed of a core material and a coating, the core material is prepared from the following raw materials by weight: 10 parts of atorvastatin calcium, 15-20 parts of a filler, 4-6 parts of an adhesive, 8-12 parts of a disintegrating agent, and 3-5 parts of a lubricant; the coating film is prepared from hydroxypropyl methyl cellulose, nano titanium dioxide and polyvinylpyrrolidone according to the mass ratio of (2 to 3): (16 to 18): 1. The atorvastatin calcium tablet is composed of the core material and the coating film, the coating film is prepared from hydroxypropyl methyl cellulose, nano titanium dioxide and polyvinylpyrrolidone according to a certain proportion, the coating uniformity is good, the coating effect is stable, and the prepared atorvastatin calcium tablet is high in coating rate and small in tablet weight difference. The atorvastatin calcium tablet prepared by the invention is good in disintegration time limit, high in stability and good in strong light resistance, high temperature resistance and high humidity resistance.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an atorvastatin calcium tablet and a preparation process thereof. Background technique [0002] Atorvastatin Calcium Tablets are mainly used to treat patients with primary hypercholesterolemia, including familial hypercholesterolemia (heterozygous type) or mixed hyperlipidemia (equivalent to Type IIa and IIb of Fredrickson classification), If diet therapy and other non-drug treatments are unsatisfactory, the application of this product can treat elevated total cholesterol (TC), elevated low-density lipoprotein cholesterol (LDL-C), elevated apolipoprotein B (Apo B) and Elevated triglycerides (TG). In patients with homozygous familial hypercholesterolemia, atorvastatin can be used in combination with other lipid-lowering therapies (such as LDL plasma dialysis) or alone (when no other treatment is available) to reduce TC and LDL-C. In the existing method, during the prep...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/32A61K31/40A61K47/02A61K47/38A61K47/32A61K47/26A61P3/06
CPCA61K9/2866A61K9/2813A61K9/284A61K9/2054A61K9/2027A61K31/40A61P3/06
Inventor 李一青蔡亲
Owner HAINAN HAILING CHEMIPHARMA CORP
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