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Stable levamlodipine composition

A technology of levamlodipine and its composition, which is applied in the field of levamlodipine pharmaceutical composition, can solve the problems of poor stability of levamlodipine and low dissolution in vitro, and achieve good stability, good repeatability, and guaranteed stability Effect

Active Publication Date: 2012-07-18
KANGYA OF NINGXIA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to overcome the disadvantages of poor stability of levamlodipine and low dissolution in vitro, the invention provides a tablet formula and preparation method of levamlodipine

Method used

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  • Stable levamlodipine composition
  • Stable levamlodipine composition
  • Stable levamlodipine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The sample dissolution curve of embodiment one The sample dissolution curve of embodiment two The sample dissolution curve of embodiment three

Embodiment 4

[0024] The sample dissolution curve of embodiment four The sample dissolution curve of embodiment five Dissolution curve of the sample of Comparative Example 1

[0025] The present invention will be further described below by taking levamlodipine besylate as an example but not limited to levamlodipine besylate.

[0026] Embodiment one

[0027] prescription:

[0028]

[0029] Process:

[0030] 1) After mixing the levamlodipine besylate and calcium hydrogen phosphate of the prescribed amount, pass through an 80-mesh standard sieve;

[0031] 2) Mix the remaining auxiliary materials with the materials in 1) evenly, and punch out tablets with a diameter of Φ6.0mm.

Embodiment 2

[0033] prescription:

[0034]

[0035] Process:

[0036] 1) cross 80 mesh standard sieves after mixing the levamlodipine besylate and calcium sulfate of prescription quantity;

[0037] 2) Mix the remaining auxiliary materials with the materials in 1) evenly, and punch out tablets with a diameter of Φ6.0mm.

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Abstract

The invention relates to a stable levamlodipine medicinal composition, which comprises an active ingredient consisting of levamlodipine or a pharmaceutically-acceptable salt thereof, a stabilizer, a filler, a disintegrating agent and a lubricating agent. The stabilizer is one or a composition of two or more than two of calcium hydrophosphate, calcium phosphate, calcium sulfate, citric acid or sodium citrate. By selecting appropriate auxiliary materials, a weakly-acid micro environment is formed in a tablet, and degradation under the conditions of moisture, heat and light illumination is blocked, so that the stable quality of a medicament is ensured.

Description

technical field [0001] The invention relates to a stable pharmaceutical composition of levamlodipine, in particular to a pharmaceutical preparation, formula composition and preparation method of levamlodipine. Background technique [0002] Levamlodipine (Levamlodipine) is the left-handed isomer of amlodipine, which is a long-acting dihydropyridine calcium ion antagonist, which can block the entry of calcium ions outside the cardiac muscle and vascular smooth muscle cells through the calcium channel of the cell membrane cells, thereby producing pharmacological effects. This product can directly relax vascular smooth muscle, reduce peripheral vascular resistance, and thus have antihypertensive effect. At the same time, this product is also an effective drug for relieving angina pectoris. It has a high affinity to blood vessels, and can significantly prolong the exercise time of patients with ischemic myocardium and the time of angina pectoris caused by exercise, and reduce th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K47/04A61K47/38A61K47/36A61K47/32A61K47/12A61K9/20A61P9/12A61P9/10
Inventor 杨亚军马永付王海东
Owner KANGYA OF NINGXIA PHARMA
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