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Nifedipine double-layer osmotic pump tablet and preparation method thereof

A double-layer, osmotic pump tablet technology, applied in coatings, pharmaceutical formulations, medical preparations with non-active ingredients, etc., to achieve the effect of improving the release rate

Pending Publication Date: 2018-07-31
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The object of the present invention is to provide a kind of nifedipine double-layer osmotic pump tablet and preparation method thereof, the nifedipine controlled-release tablet that the present invention provides has a simple preparation process, is easy to industrialized production, and it can solve the problem of existing nifedipine controlled-release tablet disadvantages, reduce cost, and have good controlled release effect

Method used

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  • Nifedipine double-layer osmotic pump tablet and preparation method thereof
  • Nifedipine double-layer osmotic pump tablet and preparation method thereof
  • Nifedipine double-layer osmotic pump tablet and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0050] (1) Drug-containing layer (per tablet):

[0051]

[0052] (2) Booster layer prescription (per tablet):

[0053]

[0054] (3) Composition of semi-permeable membrane coating solution (per 1000 tablets):

[0055]

[0056] (4) Composition of moisture-proof coating solution (per 1000 tablets):

[0057] OPADRY 03B640002 PINK Appropriate amount

[0058] For the release curve of the formulation in CN 100563638C see figure 1 , the nifedipine double-layer osmotic pump tablet release rate of embodiment 1 sees figure 2 , it can be seen that adding an appropriate amount of sodium lauryl sulfate in the drug-containing layer can significantly improve the release end point of nifedipine, so that the release of nifedipine is complete.

Embodiment 1- Embodiment 9

[0059] Embodiment 1-Example 9 Preparation process of nifedipine double-layer osmotic pump tablet:

[0060] 1. Preparation of drug-containing layer mixture: avoid light. The raw and auxiliary materials are passed through a 60-mesh sieve, and the components of the drug-containing layer in the prescribed amount are mixed uniformly in the principle of equal increase without adding a lubricant, and then mixed with the prescribed amount of magnesium stearate for 5 minutes, and set aside.

[0061] 2. Preparation of the mixture of the booster layer: mix the components of the booster layer in the prescribed amount without adding a lubricant, and mix them uniformly according to the principle of equal increase, and then mix them with the prescribed amount of magnesium stearate for 5 minutes, and set aside.

[0062] 3. Tablet compression: keep away from light. The mixture of the drug-containing layer and the mixture of the booster layer is compressed into a double-layer tablet core with a ...

Embodiment 2

[0068] (1) Drug-containing layer (per tablet):

[0069]

[0070] (2) Booster layer prescription (per tablet):

[0071]

[0072] (3) Composition of semi-permeable membrane coating solution (per 1000 tablets):

[0073]

[0074] (4) Composition of moisture-proof coating solution (per 1000 tablets):

[0075] OPADRY 03B640002 PINK Appropriate amount

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Abstract

The invention provides a nifedipine double-layer osmotic pump tablet. The nifedipine double-layer osmotic pump tablet includes a medicated-layer tablet core, a boosting-layer tablet core, a semipermeable membrane and single drug-releasing holes arranged in the surface of the semipermeable membrane at one side of a medicated layer. The nifedipine double-layer osmotic pump tablet is simple in preparation process and low in cost and has stable drug-releasing rate; zero-level release is basically realized in 416 hours, and the the drug release is basically complete; the purpose of administration of preparation once per day is achieved, and the compliance of a patient is improved. The invention provides a preparation method of a nifedipine controlled-release tablet.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a double-layer osmotic pump tablet of an antihypertensive drug nifedipine and a preparation method thereof. Background technique [0002] Nifedipine (Nifedipine) is the first dihydropyridine calcium ion channel blocker, the chemical name is 2,16-dimethyl-4(2-nitrophenyl)-1,4-dihydro-3 , dimethyl 5-pyridinedicarboxylate, used for the prevention and treatment of angina pectoris caused by coronary heart disease, especially variant angina pectoris and angina pectoris caused by coronary artery spasm; it has no adverse effect on respiratory function, so it is suitable for angina pectoris with obstructive airway diseases In addition, nifedipine still has anti-atherosclerosis, inhibits vascular smooth muscle hyperplasia, protects the integrity of the structure and function of vascular endothelial cells, and resists platelet aggregation; Dipine can signifi...

Claims

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Application Information

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IPC IPC(8): A61K9/24A61K9/32A61K9/36A61K31/4422A61K9/44A61K47/32A61K47/36A61K47/38A61P9/12
CPCA61P9/12A61K9/2027A61K9/2054A61K9/2059A61K9/2086A61K9/2853A61K9/2866A61K31/4422
Inventor 尹莉芳秦超张继睿韩清苏雨施沁青
Owner CHINA PHARM UNIV
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