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Nifedipine controlled release micro-pill preparation and preparation method thereof

A technology of nifedipine and dipine pellets, used in the field of medicine, can solve problems such as damage to the ability to drive and operate machines, gingival hyperplasia, etc.

Inactive Publication Date: 2011-05-04
HANGZHOU SHARPLY PHARM R&D INSTIT +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Nifedipine adverse reactions: headache, dizziness, fatigue; face and skin flushing, hot; tachycardia, palpitations; hypotension; swelling of lower limbs; gastrointestinal disorders such as nausea and diarrhea in rare cases; skin reactions such Itching, urticaria, rash; gynecomastia in elderly male patients with long-term use; gingival hyperplasia also occurs with long-term use; may impair the ability to drive and operate machinery

Method used

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  • Nifedipine controlled release micro-pill preparation and preparation method thereof
  • Nifedipine controlled release micro-pill preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] (1) Preparation of pill core:

[0024] Prescription: Nifedipine 800g

[0025] Sucrose Blank Ball Core 300g

[0026] Povidone 30g

[0027] Preparation process: dissolving the prescribed amount of povidone in ethanol solution to prepare a 3% povidone ethanol solution as an adhesive. Micronize nifedipine, weigh the prescription amount and add it to the hopper, put the blank pellet core in the coating granulator, spray the adhesive and start adding the drug until all the nifedipine is added, take it out and put it on the tray , Dry at 40±5°C.

[0028] (2) Controlled-release coating: Take 300g of drug-containing pill cores, and use the following coating prescription for coating:

[0029] Coating Solution Prescription:

[0030] Eudragit NE30D 100g

[0031] Talc powder 30g

[0032] water 170g

[0033] Preparation of coating solution: take the Eudragit NE30D aqueous dispersion, talcum powder and water in the prescribed amount, mix and stir evenly, and use it as a coatin...

Embodiment 2

[0039] (1) Preparation of pill core:

[0040] Prescription: Nifedipine 800g

[0041] Starch Blank Ball Core 300g

[0042] Hypromellose 30g

[0043] Preparation process: dissolving prescription amount of hydroxypropyl cellulose in ethanol solution to prepare 3% hydroxypropyl cellulose ethanol solution as binder. Micronize nifedipine, weigh the prescription amount and add it to the hopper, put the blank pellet core in the coating granulator, spray the adhesive and start adding the drug until all the nifedipine is added, take it out and put it on the tray , Dry at 40±5°C.

[0044] (2) Controlled release coating: 300g containing pill core, coated with the following coating prescription:

[0045] Coating Solution Prescription:

[0046] Eudragit RL100 100g

[0047] Talc powder 30g

[0048] water 170g

[0049] Preparation of coating solution: Take the Eudragit RL100 aqueous dispersion, talcum powder and water in the prescribed amount, mix and stir evenly, and use it as a coat...

Embodiment 3

[0057] (1) Preparation of pill core:

[0058] Prescription: Nifedipine Control 650g

[0059] Microcrystalline Cellulose Blank Ball Core 200g

[0060] Methylcellulose 30g

[0061] Preparation process: dissolving the prescribed amount of methyl cellulose in ethanol solution to prepare 3% methyl cellulose ethanol solution as a binder. Micronize nifedipine, weigh the prescription amount and add it to the hopper, put the blank pellet core in the coating granulator, spray the adhesive and start adding the drug until all the nifedipine is added, take it out and put it on the tray , Dry at 40±5°C.

[0062] (2) Sustained-release coating: remove 300g of the core of the drug-containing pill, and use the following coating prescription for coating:

[0063] Coating Solution Prescription:

[0064] Ethylcellulose 69g

[0065] Talc powder 20g

[0066] water 150g

[0067] Preparation of coating solution: take ethyl cellulose, talcum powder and water in the prescribed amount, mix and stir...

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Abstract

The invention relates to a nifedipine controlled release micro-pill preparation and a preparation method thereof. The nifedipine controlled release micro-pill preparation comprises 30% to 70% of nifedipine, 10% to 30% of empty pill core, 1% to 5% of adhesive, 15% to 40% of controlled release material and 3% to 10% of anti-sticking agent. The preparation method comprises the steps that medical active components cover the surface of the empty pill core and then are covered with the controlled release coating to prepare a nifedipine controlled release micro-pill; and finally, the capsule is filled to prepare a nifedipine controlled release capsule or the controlled release micro-pill and a filling agent are mixed and tableted to prepare nifedipine controlled release tablets. The nifedipine controlled release micro-pill preparation has the advantages of complete controlled release and stable effect, and is suitable for mass production.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a controlled-release preparation, in particular to a nifedipine controlled-release pellet preparation and a preparation method thereof. Background technique [0002] Nifedipine, the chemical name is 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylate, molecular formula C 17 h 18 N 2 o 6 , molecular weight 346.34. Nifedipine is a calcium ion influx blocker or slow channel blocker, and is a dihydropyridine calcium antagonist. These drugs mainly inhibit the calcium storage capacity or the ability to combine with calcium in the calcium storage site of the myocardial and vascular smooth muscle cell membrane, and reduce the amount of calcium ions flowing into the muscle cell through the slow channel during the action potential phase of the cell membrane, thus causing myocardial and vascular smooth muscle Calcium deficiency in the cells can not effectively contract, manifes...

Claims

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Application Information

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IPC IPC(8): A61K9/26A61K9/52A61K31/4422A61K47/32A61K47/38A61P9/10A61P9/12
Inventor 范敏华卢少林刘华赵德芳郭晓梅
Owner HANGZHOU SHARPLY PHARM R&D INSTIT
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