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Nifedipine controlled release preparation and preparation method thereof

A technology of controlled-release preparations and nifedipine, which is applied in the direction of pharmaceutical formulas, medical preparations containing active ingredients, and medical preparations containing active ingredients. Avoid problems such as the early morning danger hour

Inactive Publication Date: 2008-11-26
HANGZHOU MINSHENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the action time of nifedipine sustained-release tablets is more than 14 hours, which reduces the number of times of taking, but it cannot control its delayed release for the "morning peak phenomenon" of hypertension.
In short, the current nifedipine preparations are difficult for hypertensive patients to avoid the dangerous moment in the morning, and getting up to take the medicine in the early morning brings a lot of inconvenience to the life of the patients

Method used

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  • Nifedipine controlled release preparation and preparation method thereof
  • Nifedipine controlled release preparation and preparation method thereof
  • Nifedipine controlled release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Embodiment 1: the preparation of nifedipine controlled-release preparation

[0046] Prescription (per 1000 tablets):

[0047] Tablet core: Nifedipine 20g, HPMC K100LV15g, HPMC K100M5g, lactose 5g, sodium chloride 20g, crospovidone 5g, silicon dioxide 0.7g, medicinal ethanol 23g;

[0048] Coating layer: HPMC K100LV69g, lactose 161g, magnesium stearate 1.15g, silicon dioxide 2.3g, medicinal ethanol 130.64g.

[0049] Preparation:

[0050] (1) Tablet cores are granulated separately and pressed into tablets (φ5.5mm shallow concave punch);

[0051] (2) The coating layer is granulated separately;

[0052] (3) Press-coated chips (φ9mm shallow concave punch): first fill part of the coating layer particles in the die hole, then place the tablet core in the center of the die hole, then add the remaining coating layer particles, and then press to form a chip-coated chip.

[0053] Determination of in vitro release: according to the United States Pharmacopoeia USP29 nifedipine su...

Embodiment 2

[0055] Embodiment 2: the preparation of nifedipine controlled-release preparation

[0056] Prescription (per 1000 tablets):

[0057] Tablet core: Nifedipine 20g, HPMC K100LV 17.5g, lactose 10g, sodium chloride 17.5g, crospovidone 5g, silicon dioxide 0.7g, medicinal ethanol 18.3g;

[0058] Coating layer: HPMC K100LV69g, lactose 161g, magnesium stearate 1.15g, silicon dioxide 2.3g, medicinal ethanol 130.64g.

[0059] Preparation method: as described under Example 1.

[0060] In vitro release assay: as described under Example 1. (experimental data see table 2 and appendix figure 2 )

[0061] The results showed that the release of the drug started at intervals of 5 to 6 hours, and the sustained release time reached 14 hours.

Embodiment 3

[0062] Embodiment 3: the preparation of nifedipine controlled-release preparation

[0063] Prescription (per 1000 tablets):

[0064] Tablet core: 20g of nifedipine, 35g of HPMC K100LV, 2.5g of lactose, 10g of sodium chloride, 2.5g of crospovidone, 0.7g of silicon dioxide, 22.6g of medicinal ethanol;

[0065] Coating layer: HPMC K100LV69g, lactose 161g, magnesium stearate 1.15g, silicon dioxide 2.3g, medicinal ethanol 130.64g.

[0066] Preparation method: as described under Example 1.

[0067] In vitro release assay: as described under Example 1. (experimental data see table 3 and appendix image 3 )

[0068] The results showed that the release of the drug started at intervals of 6 to 7 hours, and the sustained release time reached 16 hours.

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Abstract

The invention provides a nifedipine controlled-release preparation that can put off release and a preparation method thereof. The controlled-release preparation can put off release for a period of time and then can release continuously to prolong the duration of drugs. Patients can take drugs before sleep and effective dose of drugs are released continuously in the morning next day, thus causing the effect of the drugs to be consistent with the rhythm of disease incidents, leading the patients with high blood pressure to safely go through the outbreak period of cardiovascular disease and overcoming the inconvenience that the conventional preparation used for the 'morning peak phenomenon' of the high blood pressure needs to be taken drugs in the wee hours.

Description

(1) Technical field [0001] The invention relates to a controlled-release preparation of antihypertensive drug nifedipine and a preparation method thereof. (2) Background technology [0002] As a calcium antagonist, nifedipine is commonly used clinically in the treatment of hypertension, angina pectoris, hypertrophic cardiomyopathy and peripheral vascular diseases. It is especially effective in treating high blood pressure and angina pectoris. It is completely absorbed orally, the plasma protein binding rate is 90%, and the metabolism is fast, and it reduces Ca by blocking vascular smooth muscle-dependent calcium channels. 2+ inflow, thereby playing a therapeutic role. Among many calcium channel blockers, nifedipine has been proven safe and effective due to its many clinical application researches and low toxic and side effects. [0003] The blood pressure of the human body shows a rhythmic change in 24 hours: the blood pressure rises rapidly to the peak within a few hours...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/4422A61K47/38A61K47/36A61K47/40A61K47/10A61P9/12A61P9/10A61P9/04
Inventor 骆快燕刘洋徐伟良郭殿武
Owner HANGZHOU MINSHENG PHARM CO LTD
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