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Tablet composition containing pitavastatin calcium and preparation method of tablet

A technology of pitavastatin calcium and composition, which is applied in the field of tablet composition containing pitavastatin calcium and its preparation field, can solve the problems of increasing the possibility of decomposition, increase the substance and the like, and achieves improved stability and related substances. The effect of low content and high practicality

Inactive Publication Date: 2014-04-02
北京华禧联合科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The traditional pitavastatin calcium tablet composition and its preparation method are wet granulated and then pressed into tablets. The raw and auxiliary materials are affected by heat and light before being pressed into tablets, which increases the possibility of decomposition and increases the number of related substances.

Method used

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  • Tablet composition containing pitavastatin calcium and preparation method of tablet
  • Tablet composition containing pitavastatin calcium and preparation method of tablet
  • Tablet composition containing pitavastatin calcium and preparation method of tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] A tablet composition containing pitavastatin calcium, comprising the following components in parts by weight:

[0038]

[0039]

[0040] A preparation method of a tablet composition containing pitavastatin calcium, comprising the following steps:

[0041] (1) Pass pitavastatin calcium through a 100-mesh sieve, Crospovidone and magnesium stearate are all passed through an 80-mesh sieve, for subsequent use;

[0042] (2) Pitavastatin calcium, crospovidone, Magnesium stearate was thrown into a mixer and mixed for 30 minutes, then set aside;

[0043] (3) Determine the content of the powder, determine the weight of the tablet, and compress the tablet;

[0044] (4) Preparation of coating solution: Add Opadry "03B84548" into purified water while stirring, then stir for 45 minutes to prepare a coating solution with a concentration of 15%, pass through a 60-mesh sieve, and set aside;

[0045] (5) Film-coating to obtain a tablet composition containing pitavastatin calc...

Embodiment 2

[0047] A tablet composition containing pitavastatin calcium, comprising the following components in parts by weight:

[0048]

[0049] A preparation method of a tablet composition containing pitavastatin calcium, comprising the following steps:

[0050] (1) Preparation of porous mannitol: After the water-soluble sorbitol is dissolved, it is spray-dried to prepare porous particles;

[0051] (2) Pass pitavastatin calcium through a 100-mesh sieve, porous mannitol, crospovidone, and magnesium stearate through a 80-mesh sieve, and set aside;

[0052] (3) Weigh the prescribed amount of pitavastatin calcium, porous mannitol, and magnesium stearate and put them in the mixer for 30 minutes and set aside;

[0053] (4) Determine the content of the powder, determine the weight of the tablet, and compress the tablet;

[0054] (5) Preparation of coating solution: Add Opadry "03B84548" into purified water while stirring, then stir for 45 minutes to prepare a coating solution with a conc...

Embodiment 3

[0057] A tablet composition containing pitavastatin calcium, comprising the following components in parts by weight:

[0058]

[0059]

[0060] A preparation method of a tablet composition containing pitavastatin calcium, comprising the following steps:

[0061] (1) Pass pitavastatin calcium through a 100-mesh sieve, porous microcrystalline cellulose-lactose complex, crospovidone, and magnesium stearate through a 80-mesh sieve, and set aside;

[0062](2) Put the prescribed amount of pitavastatin calcium, crospovidone, porous mannitol, and magnesium stearate into the mixer for 30 minutes and set aside;

[0063] (4) Determining the powder content, confirming the content of the tablet, and pressing the tablet;

[0064] (5) Preparation of coating solution: Add Opadry "03B84548" into purified water while stirring, then stir for 45 minutes to prepare a coating solution with a concentration of 15%, pass through a 60-mesh sieve, and set aside;

[0065] (6) Film-coating to obta...

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Abstract

The invention discloses a tablet composition containing pitavastatin calcium and a preparation method of the tablet composition. The tablet composition contains main medicine-pitavastatin calcium, porous filler, a disintegrating agent, a lubricating agent and opadry film premix. A direct powder compression method is adopted; the stability of a product is remarkably improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a tablet composition containing pitavastatin calcium and a preparation method thereof. technical background [0002] Pitavastatin Calcium is a new generation of hydroxymethylglutaryl-CoA reductase inhibitor, which can lower blood lipid and resist arteriosclerosis by inhibiting the synthesis of endogenous cholesterol. Clinically, it is mainly used to treat hypercholesterolemia, familial hypercholesterolemia and lipid metabolism disorders. A large number of clinical experiment data show that pitavastatin calcium generally has good drug resistance, low toxicity and side effects, and obvious therapeutic effect, which makes it have the reputation of "super statin" among statin drugs. [0003] The traditional pitavastatin calcium tablet composition and its preparation method are wet granulated and then pressed into tablets. The raw and auxiliary materials are affected by dam...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/47A61K31/4709A61P3/06A61K47/26A61K47/36A61K47/38A61K47/32A61K47/34
Inventor 庄伟平郑伟毕华
Owner 北京华禧联合科技发展有限公司
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