Pitavastatin calcium tablet pharmaceutical composition and dry or wet preparation method thereof

A technology of pitavastatin calcium and its composition, which is applied in the field of medicine, can solve the problems of insufficient use of active ingredients, easy configuration transformation, and lower cholesterol, and achieve easy control of the production process, high production efficiency, and batch-to-batch small difference effect

Active Publication Date: 2017-09-05
CHINA RESOURCES DOUBLE CRANE PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] CN102048701B (Chinese Patent Application No. 201010581413.5) discloses a pitavastatin calcium enteric-coated sustained-release pellet preparation and a preparation method thereof, which can solve the following problems in the prior art: (1) pitavastatin calcium is low in gastric juice In the pH environme

Method used

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  • Pitavastatin calcium tablet pharmaceutical composition and dry or wet preparation method thereof
  • Pitavastatin calcium tablet pharmaceutical composition and dry or wet preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0183] Embodiment 1: preparation pitavastatin calcium tablet

[0184] Tablet prescription:

[0185] Pitavastatin Calcium 1mg,

[0186] Lactose 101.4mg,

[0187] Low-substituted hydroxypropyl cellulose 12mg,

[0188] Hydroxypropyl methylcellulose (2910) 2mg,

[0189] Magnesium aluminum silicate 2.4mg,

[0190] Magnesium stearate 1.2mg;

[0191] Chip method:

[0192] (1) Pitavastatin calcium is pre-mixed with a stabilizer and part lubricant (its amount is 8% of the amount of pitavastatin calcium) and ground into fine powder that can pass through 100 meshes to obtain pitavastatin calcium mixed powder; The materials are respectively crushed into fine powders that can pass through 80 meshes, and set aside;

[0193] (2) Add the filler to the wet mixing multifunctional granulator, and slowly add the pitavastatin calcium mixed powder obtained in step (1) and all or part of the disintegrant (adding 40%) in a stirring state, well mixed;

[0194] (3) Spray an additionally prep...

Embodiment 2

[0197] Embodiment 2: preparation pitavastatin calcium tablet

[0198] Tablet prescription:

[0199] Pitavastatin Calcium 1mg,

[0200] Lactose 120mg,

[0201] Low-substituted hydroxypropyl cellulose 4mg,

[0202] Hydroxypropylmethylcellulose (1828) 5mg,

[0203] Magnesium aluminum silicate 0.5mg,

[0204] Magnesium stearate 3mg;

[0205] Chip method:

[0206] (1) Pitavastatin calcium (using its pentahydrate, the feeding amount is converted into pitavastatin calcium) is pre-mixed and pulverized together with a stabilizer and part of the lubricant (the amount is 9% of the amount of pitavastatin calcium) into a fine powder that can pass through 100 meshes to obtain pitavastatin calcium mixed powder; the rest of the materials are respectively pulverized into fine powders that can pass through 80 meshes for subsequent use;

[0207] (2) Add the filler to the wet mixing multifunctional granulator, and slowly add the pitavastatin calcium mixed powder obtained in step (1) and ...

Embodiment 3

[0211] Embodiment 3: preparation pitavastatin calcium tablet

[0212] Tablet prescription:

[0213] Pitavastatin Calcium 1mg,

[0214] Lactose (monohydrate) 40mg,

[0215] Low-substituted hydroxypropyl cellulose 20mg,

[0216] Hydroxypropyl methylcellulose (2208) 0.5mg,

[0217] Magnesium Aluminum Silicate 5mg,

[0218] Magnesium stearate 0.3mg;

[0219] Chip method:

[0220] (1) Pitavastatin calcium is pre-mixed together with stabilizer and part lubricant (its amount is 6% of the amount of pitavastatin calcium) and ground into fine powder that can pass through 100 meshes to obtain pitavastatin calcium mixed powder; The materials are respectively crushed into fine powders that can pass through 80 meshes, and set aside;

[0221] (2) Add the filler to the wet mixing multi-functional granulator, and slowly add the pitavastatin calcium mixed powder obtained in step (1) and all or part of the disintegrant (30%) in a stirring state, well mixed;

[0222] (3) Spray an addit...

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PUM

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Abstract

The invention relates to a pitavastatin calcium tablet pharmaceutical composition and a dry or wet preparation method thereof. Specifically, one aspect of the invention relates to a pitavastatin calcium tablet which comprises a tablet core and a coating layer, wherein the tablet core comprises 1 part of pitavastatin calcium, 40-120 parts of a filling agent, 4-20 parts of a disintegrating agent, 0.5-5 parts of an adhesive, 0.5-5 parts of a stabilizer and 0.3-3 parts of a lubricating agent. The tablet core can be made from lactose, microcrystalline cellulose, tricalcium phosphate, low substituted hydroxypropy cellulose, crospovidone, sodium carboxymethyl starch, aluminum-magnesium silicate, aluminum-magnesium metasilicate, hydroxypropyl methylcellulose, magnesium stearate and other excipients and combinations thereof. The tablet core can be prepared through a dry granulation tabletting process or a wet granulation tabletting process. The invention further relates to a preparation method of pitavastatin calcium tablets and application thereof in preparation of drugs for treating and/or preventing hypercholesteremia or familial hypercholesterolemia. The tablet pharmaceutical composition disclosed by the invention has excellent properties shown in the specification.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a drug for regulating blood lipids, in particular to a pharmaceutical composition of pitavastatin calcium tablets, and more particularly to preparation by dry granulation and tableting or by classical wet granulation and tableting pharmaceutical composition of pitavastatin calcium tablets. Further, the present invention relates to a method for preparing the pharmaceutical composition of pitavastatin calcium tablet by dry granulation and tabletting method or by classical wet granulation and tabletting method. The pitavastatin calcium tablet pharmaceutical composition prepared by the invention has excellent effect. Background technique [0002] Hyperlipidemia is a major disease affecting human health. Hyperlipidemia is hidden, gradually, progressive and systemic to the damage of health. Its direct damage is to accelerate systemic atherosclerosis, because vital organs of the whole...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/30A61K31/47A61K47/12A61P3/06
CPCA61K9/2013A61K9/2853A61K9/2866A61K31/47
Inventor 赵海英吴涛张丽李颍陈焕娜
Owner CHINA RESOURCES DOUBLE CRANE PHARMA COMPANY
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