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Compound of atorvastatin and levorotatory amlodipine and preparing method thereof

A technology of levamlodipine and atorvastatin, which is applied in the field of preparation of pharmaceutical compositions, can solve the problems of instability, amorphous atorvastatin is easy to absorb moisture and the like, and achieves good stability, various indicators and dissolution rates. good effect

Active Publication Date: 2008-07-23
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

[0008] After searching and analyzing the prior art, it is found that amorphous atorvastatin is easy to absorb moisture and becomes unstable after contacting with oxygen, and crystalline atorvastatin is highly sensitive to heat, humidity, low pH environment and light, Therefore, it is necessary to provide a method that can ensure the stability of various forms of atorvastatin or its pharmaceutically acceptable salts in the compound combination for the treatment of hypertension and hyperlipidemia, and at the same time ensure that it does not affect or increase the stability of the two Dosage Form for Dissolution of Active Ingredient

Method used

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  • Compound of atorvastatin and levorotatory amlodipine and preparing method thereof
  • Compound of atorvastatin and levorotatory amlodipine and preparing method thereof
  • Compound of atorvastatin and levorotatory amlodipine and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Embodiment 1: Atorvastatin calcium and levamlodipine maleate tablets

[0068] prescription:

[0069] Name Amount (g) Weight percent (%)

[0070] Levoamlodipine maleate 2.5 1.7

[0071] (equivalent to levamlodipine)

[0072] Atorvastatin Calcium 10 6.7

[0073] Calcium carbonate 1.5 1

[0074] Low-substituted hydroxypropyl cellulose 42 28

[0075] Croscarmellose sodium 9 6

[0076] β-cyclodextrin 15 10

[0077] Compressible starch 65 43.3

[0078] Magnesium stearate 1.5 1

[0079] Proper amount of povidone ethanol solution

[0080] Total weight 150g

[0081] Opadry Coating Powder Appropriate amount

[0082] The specific preparation method is as follows: the raw and auxiliary materials are pulverized respectively, and passed through a 100-mesh sieve for subsequent use; After mixing sodium carboxymethylcellulose, β-cyclodextrin, and compressible starch evenly, add an appropriate amount of the prepared adhesive povidone ethanol solution to make soft materials, g...

Embodiment 2

[0083] Embodiment 2: Atorvastatin calcium and levamlodipine maleate tablets

[0084] prescription:

[0085] Name Amount (g) Weight percent (%)

[0086] Levoamlodipine maleate 2.5 1.3

[0087] (equivalent to levamlodipine)

[0088] Atorvastatin Calcium 20 11.1

[0089] Calcium carbonate 5.4 3

[0090] Microcrystalline cellulose 102.4 56.9

[0091] Crospovidone 8 5

[0092] β-cyclodextrin 36 20

[0093] Hydroxypropyl methylcellulose ethanol solution qs 2.3

[0094] Magnesium stearate 1.5 1

[0095] Total weight 180

[0096] Opadry Coating Powder Appropriate amount

[0097] The specific preparation method is as follows: the raw and auxiliary materials are pulverized respectively, and passed through a 100-mesh sieve for subsequent use; atorvastatin calcium, levamlodipine maleate, calcium carbonate, microcrystalline cellulose, and crospovidone are weighed. , β-cyclodextrin mixed evenly, add the prepared adhesive hydroxypropyl methylcellulose ethanol solution to make soft...

Embodiment 3

[0098] Embodiment 3: Atorvastatin and levamlodipine besylate tablets

[0099] prescription:

[0100] Name Amount (g) Weight percent (%)

[0101] Levoamlodipine Besylate

[0102] (equivalent to levamlodipine) 2.5 1.0

[0103] Atorvastatin Calcium 40 16.7

[0104] Calcium carbonate 12 5

[0105] Microcrystalline cellulose 50 20.8

[0106] Crospovidone 12 5

[0107] Methyl-β-cyclodextrin 24 10

[0108] Lactose 92 38.3

[0109] Proper amount of hydroxypropyl methylcellulose ethanol solution

[0110] Magnesium stearate 1.5 0.6

[0111] Total weight 240

[0112] Opadry Coating Powder Appropriate amount

[0113] The specific preparation method is as follows: the raw and auxiliary materials are pulverized respectively, and passed through a 100-mesh sieve for subsequent use; the prescribed amount of atorvastatin calcium, levamlodipine besylate, calcium carbonate, microcrystalline cellulose, and crospovidone are weighed. , methyl-β-cyclodextrin, and lactose are mixed evenly,...

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PUM

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Abstract

The invention relates to a combination of atorvastatin and levamlodipine, mainly consists of levamlodipine or officinal salt thereof, atorvastatin or officinal salt thereof, alkali metal salt, and cyclodextrin and derivatives thereof and guarantees the stability and the bioavailability of atorvastatin and levamlodipine.

Description

technical field [0001] The invention relates to a composition of atorvastatin (atorvastatin) or a pharmaceutically acceptable salt thereof and levamlodipine or a pharmaceutically acceptable salt thereof, and a preparation method of the pharmaceutical composition. technical background [0002] Hypertension and hyperlipidemia are two important risk factors leading to diseases such as atherosclerosis, angina pectoris, myocardial infarction, cerebral infarction, and kidney damage. Therefore, it is of great significance to pay attention to hypertension and hyperlipidemia, and actively control the occurrence of cardiovascular and cerebrovascular diseases. [0003] Hypertension and hyperlipidemia are not only risk factors leading to arteriosclerosis, but also very closely related between the two. 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 nu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K9/16A61K9/20A61K9/48A61K47/10A61K47/26A61K47/38A61K47/40A61P3/06A61P9/10A61P9/12A61K31/40
Inventor 王金戌白敏杨汉煜陈素锐申东民陈玉洁刘海丽杜旭召
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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