Nifedipine osmotic pump controlled release tablet and preparation method thereof

An osmotic pump controlled-release and controlled-release tablet technology is used in medical preparations containing active ingredients, drug delivery, cardiovascular system diseases, etc. Effects of side effects

Inactive Publication Date: 2011-08-03
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the constraints of technology, conditions and pharmaceutical excipients, the pace of development is relatively slow

Method used

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  • Nifedipine osmotic pump controlled release tablet and preparation method thereof
  • Nifedipine osmotic pump controlled release tablet and preparation method thereof
  • Nifedipine osmotic pump controlled release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Tablet core drug layer prescription

[0043] Component Content mg / tablet

Nifedipine 30

Polyoxyethylene N80 80.5

Sodium chloride 18

Sodium carboxymethyl starch 20

[0044] Magnesium Stearate 1

Gaseous silica 0.5

[0045] Chip Booster Layer Prescription

[0046] Component Content mg / tablet

Polyoxyethylene Coagulant 50

Hypromellose E54 6

Sodium chloride 2

Iron Oxide 1

Magnesium Stearate 1

Gaseous silica 0.5

[0047] Tablet core preparation method:

[0048] 1. Take nifedipine and pass through a 120-mesh sieve;

[0049] 2. Weigh the main drug and related auxiliary materials according to the prescription amount, mix them evenly, add an appropriate amount of 95% ethanol soft material, granulate with a 24 mesh sieve, and dry completely by blasting at 50°C;

[0050] 3. After the granules are completely dried, sieve the granules with a 20-mesh sieve, ...

Embodiment 2

[0061] Tablet prescription:

[0062] Component Content mg / tablet

[0063] Tablet Booster Layer Prescription:

[0064] Component Content mg / tablet

[0065] Coating Solution Prescription:

[0066] Cellulose acetate

[0067] acetone

[0068] Prepare the tablet core according to the tablet core preparation method of Example 1 according to the tablet core prescription, and prepare the nifedipine of the present embodiment according to the coating solution prescription, the same aging method and punching method as in Example 1 by the conventional film coating method Finished Osmotic Pump Tablets.

Embodiment 3

[0070] Tablet prescription:

[0071] Component Content mg / tablet

[0072] Chip Booster Layer Prescription

[0073] Component Content mg / tablet

[0074] Coating solution prescription (200ml coating solution dosage)

[0075] Ethyl cellulose

[0076] Prepare the tablet core according to the tablet core preparation method of Example 1 according to the tablet core prescription, and prepare the nifedipine of the present embodiment according to the coating solution prescription, the same aging method and punching method as in Example 1 by the conventional film coating method Finished Osmotic Pump Tablets.

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Abstract

The invention provides a nifedipine osmotic pump controlled release tablet comprising a drug-containing layer tablet core, a booster layer tablet core, a coating membrane and a single drug-release pore on the surface of the controlled release tablet at one side of the drug-containing layer tablet core. The nifedipine osmotic pump controlled release tablet provided by the invention has stable medicament release velocity, basically realizes zero drug release within 0-20h and basically fully releases drug; therefore, the dosing number of a patient is reduced, and more stable blood drug concentration can be realized after a patient takes the drug. The nifedipine osmotic pump controlled release tablet provided by the invention is a safe, effective, stable, controllable and conveniently-applied medicament new preparation for clinically treating hypertension.

Description

technical field [0001] The invention relates to a double-layer osmotic pump controlled-release tablet of nifedipine used for treating cardiovascular diseases such as hypertension and a preparation method thereof. Background technique: [0002] Nifedipine is a representative drug among calcium ion antagonists, which was first developed and marketed by Bayer Company of Germany in the 1970s. After years of clinical application and in-depth research, nifedipine has become one of the first-choice drugs for the clinical treatment of hypertension and angina pectoris. [0003] Nifedipine (Nf) is a dihydropyridine calcium channel blocker, which has a good effect on angina pectoris, arrhythmia and hypertension. Since the 1980s, it has been proved by medical practice that ordinary preparations of nifedipine reflexively cause increased heart rate and activate the sympathetic nervous system, which is not conducive to the control of myocardial ischemia and heart failure, while long-actin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/44A61K31/4422A61P9/00A61P9/12
Inventor 吴正红陈钦恩和多黄海琴闻晓光
Owner CHINA PHARM UNIV
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