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Nitrendipine soft capsule

A technology for nitrendipine and soft capsules, applied in the field of nitrendipine soft capsules, can solve the problems of slow dissolution rate, poor absorption and utilization effect of patients, etc., and achieves the effects of fast dissolution rate, favorable monitoring and control, and reliable guarantee.

Active Publication Date: 2012-01-04
AONUO QINGDAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, after the nitrendipine self-microemulsifying soft capsule disintegrates in the body, nitrendipine needs to be re-emulsified before it can be absorbed and utilized. Therefore, the dissolution rate is slow, resulting in poor absorption and utilization by patients.

Method used

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  • Nitrendipine soft capsule
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  • Nitrendipine soft capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1: Nitrendipine Soft Capsules of the present invention

[0027] Content formula: polyethylene glycol 400 400g, Tween 80 20g, glycerin 20g, nitrendipine 10g;

[0028] Capsule shell formula: gelatin 1000g, glycerin 450g, glycine 100g, water 1000g, black iron oxide 20g;

[0029] Preparation of Nitrendipine Soft Capsules: Take the formula amount of gelatin, glycerin, glycine and water and heat and mix until the gelatin is dissolved, then add black iron oxide and mix evenly to obtain the capsule shell liquid, keep it warm for later use; take the formula amount of polyethylene glycol 400, spit Wen 80, glycerin, nitrendipine, mixed evenly, stirred and dissolved to make a uniform and clear content solution; the prepared capsule shell liquid and content solution were mixed and prepared into soft capsules by compression molding, dried, and immediately after surface treatment. have to.

Embodiment 2

[0030] Embodiment 2: Nitrendipine Soft Capsules of the present invention

[0031] Content formula: polyethylene glycol 600 400g, Tween 80 20g, glycerin 20g, nitrendipine 10g;

[0032] Capsule shell formula: gelatin 1000g, glycerin 500g, glycine 80g, water 1000g, black iron oxide 20g;

[0033] The method for preparing nitrendipine soft capsules is the same as in Example 1.

Embodiment 3

[0034] Embodiment 3: Nitrendipine Soft Capsules of the present invention

[0035] Content formula: polyethylene glycol 300 380g, Tween 80 30g, glycerin 30g, nitrendipine 10g;

[0036] Capsule shell formula: gelatin 1000g, glycerin 470g, maltitol 100g, sorbitol 100g, water 1000g, red iron oxide 15g;

[0037] The method for preparing nitrendipine soft capsules is the same as in Example 1.

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Abstract

The invention relates to the field of pharmaceutical pharmacy, and discloses a nitrendipine soft capsule. The soft capsule consists of contents and a capsule shell, wherein the contents comprise nitrendipine, polyethylene glycol, a solubilizer and glycerol in a mass ratio of 1:(10000-200000):(500-80000):(500-80000). In the nitrendipine soft capsule, polyethylene glycol is used as a solvent of nitrendipine, and the solubilizer and a water absorption resistant component glycerol are added to form the contents of the nitrendipine solution type soft capsule. Nitrendipine exists in the soft capsule in a solution mode and can be taken conveniently, after the capsule shell is disintegrated, nitrendipine can be directly absorbed without being re-emulsified in a body, has higher dissolution rate, and is more direct, quicker and more effective. Meanwhile, the defect of large difference in curative effect caused by imbalanced dissolution and large body difference can be solved effectively, and the bioavailability is improved, and the curative effect is stable.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a nitrendipine soft capsule. Background technique [0002] Nitrendipine, the chemical name is 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydro-3,5-methylethyl pyridinedicarboxylate, the English name is Nitrendipine, the molecular formula for C 18 h 20 N 2 o 6 , the molecular weight is 360.37, and its chemical structure is as follows: [0003] [0004] Nitrendipine is a second-generation dihydropyridine selective calcium antagonist, which was first successfully developed by Bayer AG in the world, and was first launched in West Germany in 1984. It has a strong vasodilation effect and a significant and long-lasting antihypertensive effect. Its effect on blood pressure and heart rate is similar to that of nifedipine, and it can reduce myocardial oxygen consumption. It has a protective effect on ischemic myocardium. It is clinically applicable to primary And secondary hyp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4422A61K47/34A61P9/12A61P9/04A61P9/10
Inventor 徐俊
Owner AONUO QINGDAO PHARMA