Nifedipine controlled release tablet and preparation method thereof

Abstract

The invention discloses a nifedipine controlled release tablet and a preparation method thereof. The nifedipine controlled release tablet comprises a tablet core, a coating wrapping the tablet core and a gastric-soluble film coating wrapping the coating, the tablet core comprises a drug-containing layer I, a drug-containing layer II and a boosting layer which are arranged in sequence, and a drug release hole is formed in one side of the drug-containing layer I of the coating. A three-chamber push-pull osmotic pump controlled release technology is adopted, nifedipine is rapidly released within 4 hours after being taken through the drug-containing layer I and reaches the effective blood concentration, after the effective blood concentration is reached, the drug-containing layer II starts to release drugs, and the characteristic of zero-order release is maintained within the next 20 hours, so that the nifedipine sustained release tablet is prepared. And the blood concentration is kept in an effective blood concentration range.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a nifedipine controlled-release tablet and a preparation method thereof. Background technique [0002] Nifedipine is a dihydropyridine calcium channel antagonist. This product can dilate the coronary arteries in the normal blood supply area and ischemic area at the same time, antagonize spontaneous or ergometrine-induced coronary artery spasm, and increase myocardial oxygenation in patients with coronary artery spasm. Deliver, relieve and prevent coronary spasm; can inhibit myocardial contraction, reduce myocardial metabolism, reduce myocardial oxygen consumption; dilate peripheral resistance blood vessels, reduce peripheral resistance, reduce systolic and diastolic blood pressure, and reduce cardiac afterload. It is commonly used clinically for various types of angina pectoris (especially variant angina pectoris), hypertension, refractory congestive heart failure and oth...

AI Technical Summary

Problems solved by technology

[0005] 1) Controlled-release preparations: The existing controlled-release preparations are mainly double-layer push-pull osmotic pump controlled-release preparations. Although this type of preparation can achieve zero-order release, after taking the drug, it will experience nearly two hours of release. The drug release starts after a lag time, and it takes several hours of drug release before the blood drug concentration can reach the effective therapeutic concentration. For patients who need to lower blood pressure in a short time, this type of preparation is relatively weak

[0006] 2) Sustained-release preparations: Although the time lag of sustained-release preparations is short and the drug action time is long, the drug cannot exhibit a good zero-order release, which is greatly affected by factors such as the pH value of the medium environment, gastrointestinal motility, and food. , poor correlation in vitro and in vivo

[0007] 3) Ordinary preparations: Ordinary preparations can easily cause large fluctuations in blood drug concentration, and the number of daily doses is large, which greatly weakens the safety, effectiveness and patient compliance of the drug

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