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Azelnidipine and isosorbide dinitrate compound composition

A technology of isosorbide dinitrate and dipine nitric acid is applied in directions such as pharmaceutical combinations, active ingredients of heterocyclic compounds, pharmaceutical formulations, etc., and can solve the problems of high packaging cost, inconvenient taking, high dosage of separate tableting auxiliary materials, etc., and achieve convenient taking. , reducing the dosage, the effect of high effective ratio of drugs

Active Publication Date: 2011-05-18
QINGDAO HUANGHAI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since a single drug often cannot achieve the desired curative effect, two or more antihypertensive drugs are often used in combination in clinical practice to achieve better antihypertensive effects; however, the combination of two or more unilateral antihypertensive drugs Application, inconvenient to take, relatively large amount of excipients for tablet compression, and high packaging cost, so making two or more antihypertensive drugs into compound preparations is not only convenient for medication, but also reduces the cost of excipients and packaging, which is beneficial Reduce drug prices and industrialize production

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] The composition of the present invention is prepared from the raw and auxiliary materials in the following weight ratio:

[0036] Azhedi level ordinary layer:

[0037] Azedipine 2%

[0038] Starch 18%

[0039] Polysorbate 0.5%

[0040] Sodium Carboxymethyl Starch 15%

[0041] Magnesium Stearate 0.1%

[0042] Isosorbide Dinitrate Extended Release Layer:

[0043] Isosorbide Dinitrate 8%

[0044] Sodium Alginate 35%

[0045] Starch 21%

[0046] Polysorbate 0.1%

[0047] Magnesium Stearate 0.3%

[0048] Prepare materials according to the above-mentioned preparation components, pulverize and pass through a 80-mesh sieve; pass azhedipine and isosorbide dinitrate through a 100-mesh sieve; mix the slow-release layer and the ordinary layer separately, wet granulate, and granulate through a 16-mesh sieve; For the second compression of the double-layer tablet press, the slow-release layer is pressed first, and the normal layer is pressed after the slow-release layer is q...

Embodiment 2

[0050] The composition of the present invention is prepared from the raw and auxiliary materials in the following weight ratio:

[0051] Azhedi level ordinary layer:

[0052] Azedipine 3%

[0053] Microcrystalline Cellulose 20%

[0054] Polysorbate 0.3%

[0055] Sodium Starch Carboxymethyl 13%

[0056] Magnesium Stearate 0.2%

[0057] Isosorbide Dinitrate Extended Release Layer:

[0058] Isosorbide Dinitrate 10%

[0059] Sodium Alginate 25%

[0060] Starch 28%

[0061]Polysorbate 0.4%

[0062] Magnesium Stearate 0.1%

[0063] Prepare materials according to the above-mentioned preparation components, pulverize and pass through a 80-mesh sieve; pass azhedipine and isosorbide dinitrate through a 100-mesh sieve; mix the slow-release layer and the ordinary layer separately, wet granulate, and granulate with a 24-mesh sieve; For the second compression of the double-layer tablet press, the slow-release layer is pressed first, and the normal layer is pressed after the slow-r...

Embodiment 3

[0065] The composition of the present invention is prepared from the raw and auxiliary materials in the following weight ratio:

[0066] Azhedi level ordinary layer:

[0067] Azedipine 4%

[0068] Starch 15%

[0069] Polysorbate 0.2%

[0070] Low-substituted propylated cellulose 10%

[0071] Micronized silica gel 0.1%

[0072] Isosorbide Dinitrate Extended Release Layer:

[0073] Isosorbide Dinitrate 20%

[0074] Sodium Alginate 25%

[0075] Starch 25%

[0076] Polysorbate 0.4%

[0077] Micronized silica gel 0.3%

[0078] Prepare materials according to the above-mentioned preparation components, pulverize and pass through a 100-mesh sieve; pass azhedipine and isosorbide dinitrate through a 100-mesh sieve; mix the slow-release layer and the ordinary layer separately, then wet granulate, and granulate through a 20-mesh sieve; For the second compression of the double-layer tablet press, the slow-release layer is pressed first, and the normal layer is pressed after the s...

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PUM

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Abstract

The invention relates to an azelnidipine and isosorbide dinitrate compound composition, which consists of an azelnidipine common layer and an isosorbide dinitrate slow-release layer. Each unit preparation comprises 2-8mg of azelnidipine and 5-40mg of isosorbide dinitrate and each tablet is 0.1g theoretically. Azelnidipine and isosorbide dinitrate are organically combined to reduce the dosage of medical accessories to a maximum extent, which can not only relieve angina and reduce the blood pressure stably, but also improve the survival rate of the patients. The compound composition has high medical effective ratio and is convenient to take and beneficial for price reduction and industrialized production.

Description

technical field [0001] The invention relates to a compound composition capable of relieving angina pectoris and stably lowering blood pressure, in particular to a compound composition of azedipine-isosorbide dinitrate. Background technique [0002] According to statistics, the number of hypertensive adults among Chinese adults was 30 million in 1960, 59 million in 1980, and increased to 94 million in 1991. Every year, 1.5 million people in our country die from stroke caused by high blood pressure. According to the calculation of my country's total population and population composition in 2000, the number of patients with hypertension in my country has reached 130 million. This figure also makes my country the country with the most serious hypertension in the world. Therefore, the market space for developing new antihypertensive drugs will be huge. [0003] The currently used Azedipine preparation has a selective blocking effect on the calcium channel of arterial smooth mus...

Claims

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Application Information

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IPC IPC(8): A61K31/4427A61K31/34A61K9/24A61P9/10A61P9/12
Inventor 赵明媚吴立明鲁大东何经涌任晓飞马德宝
Owner QINGDAO HUANGHAI PHARM CO LTD
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