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Composition of atorvastatin and L-amlodipine and preparation method thereof

A technology of levamlodipine and atorvastatin, which is applied in the field of preparation of the pharmaceutical composition, can solve problems such as potential safety hazards, cumbersome operation process, increased process cost, etc., and achieves reduction of related substances, simple preparation process, and tablet compression or fill smooth effect

Active Publication Date: 2008-10-22
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] CN200710007667.4 applied by our company discloses a compound preparation that uses basic metal salts to increase the stability of atorvastatin calcium, and uses cyclodextrin derivatives to improve the dissolution rate of amlodipine. This method adopts a wet granulation process, which can smoothly The tablet preparation is completed, but ethanol is used as a binder in this process, and the operation process is cumbersome, which increases the process cost and brings certain safety hazards

Method used

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  • Composition of atorvastatin and L-amlodipine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment 1: Atorvastatin calcium and levamlodipine maleate tablets

[0039] prescription:

[0040] Name Amount (g) Weight percent (%)

[0041] Levoamlodipine maleate 2.5 1.67

[0042] (equivalent to levamlodipine)

[0043] Atorvastatin Calcium 10 6.67

[0044] Calcium carbonate 1.5 1

[0045] β-cyclodextrin 15 10

[0046] Microcrystalline Cellulose PH101 67 44.67

[0047] Pregelatinized starch 43.5 29

[0048] Croscarmellose sodium 9 6

[0049] Magnesium stearate 1.5 1

[0050] Total weight 150g

[0051] Opadry Coating Powder Appropriate amount

[0052] The specific preparation method is as follows: pulverize amlodipine and pass through a 100-mesh sieve for later use; weigh the raw and auxiliary materials of the prescription amount, mix them uniformly according to the method of equal amount addition, compress into tablets, and coat to obtain coated tablets.

Embodiment 2

[0053] Embodiment 2: Atorvastatin calcium and levamlodipine maleate tablets

[0054] prescription:

[0055] Name Amount (g) Weight percent (%)

[0056] Levoamlodipine maleate 2.5 1.25

[0057] (equivalent to levamlodipine)

[0058] Atorvastatin Calcium 20 10

[0059] Calcium carbonate 6 3

[0060] β-cyclodextrin 40 20

[0061] Microcrystalline Cellulose PH301 94.5 47.25

[0062] Lactose (particle size > 100 mesh) 25 12.50

[0063] Crospovidone 10 5

[0064] Magnesium stearate 2 1

[0065] Total weight 200

[0066] Opadry Coating Powder Appropriate amount

[0067] The specific preparation method is as follows: pulverize the amlodipine and pass through a 100-mesh sieve for later use; weigh the raw and auxiliary materials according to the prescription amount, mix them uniformly according to the method of equal volume addition, compress into tablets, and coat to obtain coated tablets.

Embodiment 3

[0068] Embodiment 3: Atorvastatin and levamlodipine besylate tablets

[0069] prescription:

[0070] Name Amount (g) Weight percent (%)

[0071] Levoamlodipine besylate 2.5 0.78

[0072] (equivalent to levamlodipine)

[0073] Atorvastatin Calcium 40 12.50

[0074] Calcium carbonate 16 5

[0075] Methyl-β-cyclodextrin 32 10

[0076] microcrystalline cellulose 210.3 65.72

[0077] Crospovidone 16 5

[0078] Magnesium stearate 1.92 0.60

[0079] Micropowder silica gel 1.28 0.40

[0080] Total weight 320

[0081] Opadry Coating Powder Appropriate amount

[0082] The specific preparation method is as follows: pulverize the amlodipine and pass through a 100-mesh sieve for later use; weigh the raw and auxiliary materials according to the prescription amount, mix them uniformly according to the method of equal volume addition, compress into tablets, and coat to obtain coated tablets.

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Abstract

A combination of Atorvastatin and L-amlodipine is composed of L-amlodipine or medicated salt thereof, Atorvastatin or medicated salt thereof, alkaline metallic salt, cyclodextrin and derivant thereof, loading agent, disintegrant and lubricant; the combination improves the stability and bioavailability of Atorvastatin and L-amlodipine compound.

Description

technical field [0001] The invention relates to a composition of atorvastatin (atorvastatin) or its pharmaceutically acceptable salt and levamlodipine or its pharmaceutically acceptable salt, and a preparation method of the pharmaceutical composition. technical background [0002] Hypertension and hyperlipidemia are not only two important risk factors leading to atherosclerosis, angina pectoris, myocardial infarction, cerebral infarction, kidney damage and other diseases, but also have a close relationship between them. Both are more likely to occur in obese people; those who are addicted to high-fat, high-salt, high-sugar diet, or those who are addicted to tobacco and alcohol; There are also a large number of research data that show that many hypertensive patients are accompanied by lipid metabolism disorders, and the content of cholesterol and triglycerides in the blood is significantly higher than that of normal people. On the other hand, many hyperlipidemias are often c...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K47/40A61K47/36A61K47/38A61K47/02A61K47/10A61K47/30A61K9/28A61K9/48A61P3/06A61P9/10A61P9/12A61K31/40
Inventor 王金戌白敏刘海丽陈素锐杜旭召陈玉洁杨汉煜庄红林
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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