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Nifedipine slow-release tablet for treating hypertensive emergency and preparation technology thereof

A technology of nifedipine and nifedipine, applied in the field of nifedipine sustained-release tablets, can solve problems such as poor drug solubility, achieve complete drug release, meet the treatment of hypertensive emergencies, and accelerate the release effect

Active Publication Date: 2015-10-28
CHANGZHOU NO 4 PHARMA FACTORY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] The first thing to be solved in the present invention is the problem of poor drug solubility. After a large number of tests, the inventor adopts the method of preparing solid dispersion to improve the solubility of the drug.

Method used

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  • Nifedipine slow-release tablet for treating hypertensive emergency and preparation technology thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] (1) Coated ball core

[0036]Cross-linked polyvinylpyrrolidone 100g

[0037] Gastric coating powder 5g

[0038] 50% ethanol solution 50g

[0039] (2) Immediate-release pellets

[0040] Coated ball core 105g

[0041] Nifedipine 10g

[0042] Hypromellose 10g

[0043] Copovidone VA64 1g

[0044] Absolute ethanol 200g

[0045] (3) Sustained-release pellets

[0046] Immediate release pellets 100g

[0047] Ethylcellulose 15g

[0048] Hypromellose 1.5g

[0049] Sodium stearyl fumarate 1.5g

[0050] Absolute ethanol 300g

[0051] (3) Sustained-release tablets

[0052] Immediate release pellets 20g

[0053] Sustained-release pellets 80g

[0054] Lactose (Followlac 100) 200g

[0055] Croscarmellose Sodium 10g

[0056] Zinc stearate 4g

[0057] Preparation Process:

[0058] (1) Add the stomach-soluble coating powder into the stirred 50% ethanol solution, keep stirring until uniformly dispersed, and set aside; use a 40-mesh sieve to remove the fine powder of cros...

Embodiment 2

[0064] (1) Coated ball core

[0065] Cross-linked polyvinylpyrrolidone 100g

[0066] Gastric coating powder 7.5g

[0067] 50% ethanol solution 100g

[0068] (2) Immediate-release pellets

[0069] Coated ball core 107.5g

[0070] Nifedipine 10g

[0071] Hypromellose 20g

[0072] Copovidone VA64 2g

[0073] Absolute ethanol 400g

[0074] (3) Sustained-release pellets

[0075] Immediate release pellets 100g

[0076] Ethyl cellulose 20g

[0077] Hypromellose 3g

[0078] Sodium stearyl fumarate 3g

[0079] Absolute ethanol 400g

[0080] (3) Sustained-release tablets

[0081] Immediate release pellets 20g

[0082] Sustained-release pellets 80g

[0083] Microcrystalline Cellulose (M102) 200g

[0084] Low-substituted hydroxypropyl cellulose 10g

[0085] Magnesium Stearate 4g

[0086] Preparation Process:

[0087] (1) Add the stomach-soluble coating powder into the stirred 50% ethanol solution, keep stirring until uniformly dispersed, and set aside; use a 40-mesh sie...

Embodiment 3

[0093](1) Coated ball core

[0094] Cross-linked polyvinylpyrrolidone 100g

[0095] Gastric coating powder 15g

[0096] 50% ethanol solution 150g

[0097] (2) Immediate-release pellets

[0098] Coated ball core 115g

[0099] Nifedipine 10g

[0100] Hypromellose 35g

[0101] Copovidone VA64 3g

[0102] Absolute ethanol 600g

[0103] (3) Sustained-release pellets

[0104] Immediate release pellets 100g

[0105] Ethylcellulose 25g

[0106] Hypromellose 5g

[0107] Sodium stearyl fumarate 5g

[0108] Absolute ethanol 500g

[0109] (3) Sustained-release tablets

[0110] Immediate release pellets 20g

[0111] Sustained-release pellets 80g

[0112] Mannitol (200SD) 200g

[0113] Sodium carboxymethyl starch 10g

[0114] Calcium Stearate 4g

[0115] Preparation Process:

[0116] (1) Add the stomach-soluble coating powder into the stirred 50% ethanol solution, keep stirring until uniformly dispersed, and set aside; use a 40-mesh sieve to remove the fine powder of cros...

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Abstract

The invention discloses a nifedipine slow-release tablet for treating hypertensive emergency and a preparation technology thereof. The nifedipine slow-release tablet is composed of a quick-release pellet, a slow-release pellet and other auxiliary materials which are acceptable in pharmacy. The quick-release pellet sequentially comprises a core pellet, a separating coating layer and a medicine-containing layer. The medicine-containing layer is composed of nifedipine, hydroxy propyl cellulose and copovidone VA64. The slow-release pellet is composed of slow-release coating of the slow-release pellet. According to the nifedipine slow-release tablet for treating the hypertensive emergency, the purposes of quick effect taking, long-term stable medicine release and complete later-period medicine release are achieved, so that the need of curing the hypertensive emergency is met.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a drug sustained-release preparation, in particular to a nifedipine sustained-release tablet for treating hypertensive emergencies and a preparation process thereof. Background technique [0002] Nifedipine is a dihydropyridine calcium ion channel antagonist, which is suitable for various types of hypertension and has a good effect on intractable and severe hypertension. Because it can reduce afterload, it also has good curative effect on refractory congestive heart failure and is suitable for long-term use. Nifedipine has the strongest effect on expanding coronary arteries and peripheral arteries, and has a significant effect on inhibiting vasospasm. It is the drug of choice for variant angina. It is clinically applicable to the prevention and treatment of angina pectoris caused by coronary heart disease, especially variant angina pectoris and an...

Claims

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Application Information

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IPC IPC(8): A61K9/26A61K31/4422A61K47/38A61K47/32A61P9/12A61P9/04
Inventor 白强
Owner CHANGZHOU NO 4 PHARMA FACTORY
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