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Solid self-emulsifying oral administration system of dihydropyridine calcium ion antagonist and preparation method thereof

The technology of calcium ion antagonist and dihydropyridine is applied in the solid self-emulsifying oral drug delivery system of dihydropyridine calcium ion antagonist and its preparation field, and can solve the problem of single dosage form, limitation of industrial production, and compatibility of capsule and shell. Drug precipitation and leakage, etc., to achieve the effect of facilitating dose distribution, improving bioavailability, and reducing fluctuations in blood drug concentration

Inactive Publication Date: 2010-01-06
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Clinically, the system is generally divided into soft capsules for oral administration. Compared with traditional solid preparations, not only the dosage form is single, limiting industrial production, but also problems such as capsule-shell compatibility, drug precipitation and leakage, etc.

Method used

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  • Solid self-emulsifying oral administration system of dihydropyridine calcium ion antagonist and preparation method thereof
  • Solid self-emulsifying oral administration system of dihydropyridine calcium ion antagonist and preparation method thereof
  • Solid self-emulsifying oral administration system of dihydropyridine calcium ion antagonist and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1 (drug-containing self-emulsifying system)

[0025] Prescription composition:

[0026] Nitrendipine 10%

[0027]Miglyol 812 30%

[0028] Cremophor RH40 40%

[0029] Tween 80 10%

[0030] Transcutol P 10%

[0031]

[0032] Preparation process: Take the prescribed amount of oil phase, surfactant and co-surfactant, mix evenly, add the prescribed amount of drug, and stir it with a magnetic force at 50°C to completely dissolve it to form a uniform drug-containing self-emulsifying system.

Embodiment 2

[0034] Prescription composition:

[0035] Felodipine 5%

[0036] Labrafil M 1944CS 70%

[0037] Cremophor RH40 20%

[0038] Transcutol P 5%

[0039]

[0040] The preparation process is the same as in Example 1.

Embodiment 3

[0042] Prescription composition:

[0043] Felodipine 5%

[0044] Labrafil M 1944CS 10%

[0045] Cremophor RH40 80%

[0046] Transcutol P 5%

[0047]

[0048] The preparation process is the same as in Example 1.

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Abstract

The invention relates to a solid self-emulsifying oral administration system of a fat-soluble dihydropyridine calcium ion antagonist and a preparation method thereof. The solid self-emulsifying oral administration system comprises a fat-soluble dihydropyridine calcium ion antagonist and a solid medicine transmission system. The preparation method comprises the following steps: taking an oil phase, a surfactant and a cosurfactant according to the quantity of a recipe, evenly mixing, adding a medicine according to the quantity of the recipe, stirring by magnetic force at 50 DEG C, completely dissolving and evenly mixing the medicine, and forming a uniform medicine-containing self-emulsifying system. If the system is in a solid state at room temperature, the system can be prepared into a self-emulsifying semisolid skeleton capsule after being heated and melted; the system also can be prepared into various oral solid preparation forms after the medicine-containing self-emulsifying system is solidified by adopting an adsorbent; and the system also can be prepared into corresponding slow-release and controlled-release solid preparations by selecting an appropriate skeleton material and a coating technique. The preparation method is simple and convenient, has low cost and is convenient for industrialized production, and the obtained solid preparation has diversified preparation forms, convenient taking, high bioavailability, stable blood concentration, good stability and convenient storage and transportation.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a solid self-emulsifying oral administration system of a dihydropyridine calcium ion antagonist and a preparation method thereof. Background technique [0002] Cardiovascular disease is currently one of the most important killers that endanger human health, and hypertension is the most common cardiovascular disease in all countries in the world. With the improvement of people's living standards in our country, the number of hypertensive patients is increasing, and there is a trend of younger people. Hypertension is related to the occurrence of many diseases and is an important risk factor for major cardiovascular complications including congestive heart failure, stroke, coronary heart disease and renal failure. It has become the primary disease that threatens the life and health of our people. Therefore, actively developing safe and effective drugs and preparations for treating...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/20A61K9/22A61K9/48A61K9/52A61K47/44A61K47/34A61K47/32A61K47/38A61K31/4422A61P9/12A61K47/14
Inventor 何仲贵王志远孙进刘晓红王永军
Owner SHENYANG PHARMA UNIVERSITY
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