Trimetazidine hydrochloride single-layer osmotic pump controlled release tablet and preparation method thereof

Abstract

The invention provides a trimetazidine hydrochloride single-layer osmotic pump controlled release tablet and a preparation method thereof. The osmotic pump is composed of a tablet core, a semipermeable membrane and small drug release holes. The tablet core contains the following components, by weight: 30% to 40% of trimetazidine hydrochloride, 20% to 55% of a penetration enhancer, 5% to 20% of a release regulator and 0.1% to 3% of a lubricant. The semipermeable membrane includes a semipermeable membrane forming material and a pore-foaming agent; the semipermeable membrane forming material accounts for 90% to 99%, the pore-foaming agent accounts for 1% to 10%; and the weight gain of the coating accounts for 5% to 15% of the mass of the tablet core; and the pore diameter of the drug releasepores on the surface of the semipermeable membrane is 0.4 mm to 1. 2mm. The trimetazidine hydrochloride single-layer osmotic pump controlled release tablet is taken once a day; the 12-hour cumulativerelease percentage of the medicine is 60 to 70%, release time lag is avoided; the stable blood concentration in the body is maintained while the medicine can take effect quickly; the toxic and side effects are reduced; and patient compliance is improved. The drug release behavior of the preparation is not influenced by physiological factors such as gastrointestinal tract peristalsis and pH.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to trimetazidine hydrochloride single-layer osmotic pump controlled-release tablets and a preparation method thereof. Background technique [0002] Angina pectoris is a clinical syndrome characterized by paroxysmal chest pain or chest discomfort caused by coronary insufficiency and acute temporary ischemia and hypoxia of the myocardium. Among them, stable angina pectoris (stable angina pectoris) is the most common type of angina pectoris, and it occurs more frequently in middle-aged and elderly people. There is no change in the nature and location of the pain, the duration of the pain is similar, and the curative effect will be produced in a similar time after taking the medicine. Patients with stable angina are at risk of developing acute coronary syndromes, such as unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myoca...

AI Technical Summary

Problems solved by technology

[0006] Patent CN103735528B discloses a preparation method of a trimetazidine hydrochloride double-layer osmotic pump. The double-layer tablet has high requirements on equipment and technology, and no coloring agent is added to the prescription during design. The selected raw and auxiliary materials are all white. Aperturb equipment cannot differentiate drug-containing layer from booster layer

[0007] Patent CN103550183B discloses a preparation method of trimetazidine hydrochloride single-layer osmotic pump. The patent improves drug hysteresis and drug release end residue by optimizing the filler combination, but the composition of excipients is complicated, and the drug will be released within 12 hours. Take the medicine twice a day

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