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Tablet comprising atorvastatin calcium alkaline solid dispersoid and preparation method of tablet

A technology of atorvastatin calcium and solid dispersion, which is applied in the direction of medical preparations of non-active ingredients, active ingredients of heterocyclic compounds, and pill delivery, which can solve problems such as increased substances, complicated processes, and poor stability, and achieve High dissolution rate, high bioavailability and good stability

Inactive Publication Date: 2018-05-08
乐普制药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Chinese patent CN02309462A provides a kind of atorvastatin calcium tablet, adopts dry secondary granulation technology, process is relatively complicated, stability is poor, and can not dissolve completely in acid
This patent adds 22.01 parts of calcium carbonate as a filler, and is coated with a thin coating film. At the same time, polysorbate 80 is added as a dissolution accelerator. The calcium carbonate in it can play a stabilizing role, but it still cannot completely solve the problem of related substances in the storage process. raised questions

Method used

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  • Tablet comprising atorvastatin calcium alkaline solid dispersoid and preparation method of tablet
  • Tablet comprising atorvastatin calcium alkaline solid dispersoid and preparation method of tablet
  • Tablet comprising atorvastatin calcium alkaline solid dispersoid and preparation method of tablet

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Atorvastatin calcium tablet and preparation process

[0037]

[0038] Preparation Process

[0039] (1) Dissolve the prescribed amount of atorvastatin calcium in 30% methanol solution, add the prescribed amount of copovidone to dissolve, add calcium hydroxide to adjust the pH to 9.0, remove the solvent by fluidized bed drying, and obtain a solid dispersion Body spare.

[0040] (2) After mixing the prescription amount of atorvastatin calcium solid dispersion, lactose, microcrystalline cellulose, and crospovidone for 10 minutes, add the prescription amount of magnesium stearate, mix for 2 minutes, and press the theoretical tablet weight Tablets were carried out to obtain plain tablets.

[0041] (3 Use a high-efficiency coating machine, put the atorvastatin calcium tablets into the coating pan, control the tablet bed temperature to about 50°C, and the flow rate to be 40g / min, and coat.

Embodiment 2

[0043] Atorvastatin calcium tablet and preparation process

[0044]

[0045]

[0046] Preparation Process

[0047] (1) Dissolve the prescribed amount of atorvastatin calcium in 30% methanol solution, add the prescribed amount of copovidone to dissolve, add calcium hydroxide to adjust the pH to 10.0, remove the solvent by fluidized bed drying, and obtain a solid dispersion Body spare.

[0048] (2) After mixing the prescription amount of atorvastatin calcium solid dispersion, lactose, microcrystalline cellulose, and crospovidone for 10 minutes, add the prescription amount of magnesium stearate, mix for 2 minutes, and press the theoretical tablet weight Tablets were carried out to obtain plain tablets.

[0049] (3) Put the atorvastatin calcium tablet into the coating pan with a high-efficiency coating machine, control the tablet bed temperature to about 50°C, and the flow rate to 40g / min, and coat.

Embodiment 3

[0051] Atorvastatin calcium tablet and preparation process

[0052]

[0053]

[0054] Preparation Process

[0055] (1) Dissolve the prescribed amount of atorvastatin calcium in 30% methanol solution, add the prescribed amount of copovidone to dissolve, add calcium hydroxide to adjust the pH to 11.0, remove the solvent by fluidized bed drying, and obtain a solid dispersion Body spare.

[0056] (2) After mixing the prescription amount of atorvastatin calcium solid dispersion, lactose, microcrystalline cellulose, and crospovidone for 10 minutes, add the prescription amount of magnesium stearate, mix for 2 minutes, and press the theoretical tablet weight Tablets were carried out to obtain plain tablets.

[0057] (3) Put the atorvastatin calcium tablet into the coating pan with a high-efficiency coating machine, control the tablet bed temperature to about 50°C, and the flow rate to 40g / min, and coat.

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Abstract

The invention provides a tablet comprising an atorvastatin calcium alkaline solid dispersoid and a preparation method of the tablet. The solid dispersoid comprises atorvastatin calcium, a water-soluble copolymer and a pH (potential of hydrogen) regulator. The tablet is prepared by adding a filler, a disintegrant and a lubricant into the solid dispersoid and has the characteristics of good dissolubility, high stability, quick in vivo absorption, small individual variation and uniform absorption during administration for many times. At the same time, the method is simple in preparation technology and suitable for large-scale production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a tablet containing atorvastatin calcium-alkaline solid dispersion and a preparation method thereof. technical background [0002] Atorvastatin Calcium (Atorvastatin Calcium) is a blood lipid-lowering drug that can reduce the level of low-density lipoprotein cholesterol in patients with hypercholesterolemia. It is used for the treatment of hypercholesterolemia and coronary heart disease. In 1991, Warner-Lamber of the United States Atorvastatin Calcium Tablets was invented by the company, which was first launched in 1997. The chemical name of atorvastatin calcium is: [R-(R*,R*)]-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(methylethyl)-3- Calcium phenyl-[(aniline)carbonyl]-1-hydro-pyrrole-1-heptanoate trihydrate. [0003] The structural formula is as follows: [0004] [0005] Atorvastatin is a selective and competitive inhibitor of hydroxymethylglutar...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/28A61K47/32A61K47/38A61K31/40A61P3/06A61P9/10
CPCA61K9/2027A61K9/2054A61K9/28A61K31/40
Inventor 俞悦张金梁潘裕生陈岑波王海翔洪华斌
Owner 乐普制药科技有限公司
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