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Atenolol and amlodipine bilayer tablet

A double-layer tablet, amlodipine technology, applied in the field of medicine, can solve the problems of unqualified dissolution and uneven dissolution of active ingredients, etc.

Active Publication Date: 2011-06-08
CHINA RESOURCES DOUBLE CRANE PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the inventors have further found that designing atenolol and amlodipine into a double-layer tablet will cause new problems, that is, uneven dissolution and / or unqualified dissolution of one or even two active ingredients The problem

Method used

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  • Atenolol and amlodipine bilayer tablet
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  • Atenolol and amlodipine bilayer tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Embodiment 1: Preparation of atenolol-amlodipine bilayer tablet

[0055] Plain Tablet Prescription:

[0056] (1) Atenolol layer:

[0057] Atenolol

10 mg,

Calcium hydrogen phosphate

50mg,

microcrystalline cellulose

7.5 mg,

Sodium carboxymethyl starch

2.5 mg,

pvp K30

Appropriate amount,

Magnesium stearate

0.35 mg;

[0058] (2) Amlodipine layer:

[0059] Amlodipine

1mg (base-based),

Calcium hydrogen phosphate

50mg,

microcrystalline cellulose

7.5 mg,

Sodium carboxymethyl starch

0.75mg,

pvp K30

Appropriate amount,

Magnesium stearate

0.35 mg.

[0060] Prescription of film coating solution (according to 1000ml):

[0061] Hydroxypropyl methylcellulose 20.0g, Tween-808.0g, talcum powder 15.0g, titanium dioxide 10.0g, solvent is 50% ethanol.

[0062] Preparation Process:

[0063] Take prescription amount of atenolol,...

Embodiment 2

[0064] Embodiment 2: the preparation of atenolol-amlodipine bilayer tablet

[0065] Plain Tablet Prescription:

[0066] (1) Atenolol layer:

[0067] Atenolol

15 mg,

Calcium hydrogen phosphate

40mg,

microcrystalline cellulose

10 mg,

Sodium carboxymethyl starch

2 mg,

pvp K30

Appropriate amount,

Magnesium stearate

0.3 mg;

[0068] (2) Amlodipine layer:

[0069] Amlodipine

2mg (calculated by base),

Calcium hydrogen phosphate

40mg,

microcrystalline cellulose

10mg,

Sodium carboxymethyl starch

0.5 mg,

pvp K30

Appropriate amount,

Magnesium stearate

0.3 mg.

[0070] Preparation Process:

[0071] According to the prescription listed above, basically carry out tablet making according to the preparation process of Example 1, and the double-layer tablet coating prepared.

Embodiment 3

[0072] Embodiment 3: Preparation of atenolol-amlodipine bilayer tablet

[0073] Plain Tablet Prescription:

[0074] (1) Atenolol layer:

[0075] Atenolol

5 mg,

Calcium hydrogen phosphate

60mg,

microcrystalline cellulose

5 mg,

Sodium carboxymethyl starch

3 mg,

pvp K30

Appropriate amount,

Magnesium stearate

0.4 mg;

[0076] (2) Amlodipine layer:

[0077] Amlodipine

1mg (base-based),

Calcium hydrogen phosphate

60mg,

microcrystalline cellulose

5 mg,

Sodium carboxymethyl starch

1.0 mg,

pvp K30

Appropriate amount,

Magnesium stearate

0.4mg.

[0078] Preparation Process:

[0079] According to the prescription listed above, basically carry out tablet making according to the preparation technology of embodiment 1.

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PUM

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Abstract

The invention relates to an atenolol and amlodipine bilayer tablet. Particularly, the invention relates to a bilayer tablet comprising a first tablet layer and a second tablet layer, wherein the first tablet layer contains atenolol as an active constituent and a pharmaceutically acceptable excipient or accessory, and the second tablet layer contains amlodipine as an active constituent or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable excipient or accessory. The invention also provides a preparation method of the bilayer tablet. The bilayer tablet provided by the invention not only has favorable stability, but also has favorable dissolution rate.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a double-layer tablet containing atenolol and amlodipine. The tablet has better stability and can be used for treating hypertension. Background technique [0002] Cardiovascular disease is one of the most important diseases that seriously affect human health. Hypertension is the most common cardiovascular disease and a major public health problem worldwide. Compared with single drug therapy, combined drug therapy in the treatment of hypertension has the following advantages: (1) It is easier to control blood pressure and reduce complications by using two drugs with different mechanisms of action; (2) The combined use of two low-dose drugs can avoid side effects ; (3) Fixed low-dose compound preparations can improve compliance. [0003] Chinese patent application publication CN1785185A (application number: 200410096834.3, publication date: June 14, 2006) discloses a novel compound...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K31/165A61K9/20A61P9/12A61P9/00
CPCA61K31/165A61K9/209A61K31/4422A61K9/2086A61P9/00A61P9/12
Inventor 吴翠栓黄晶晶邱彤吴曼林营亚萍吴涛
Owner CHINA RESOURCES DOUBLE CRANE PHARMA COMPANY
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