Preparation method of amlodipine losartan potassium compound composition

Abstract

The invention discloses a preparation method of an amlodipine and losartan potassium compound composition. The preparation method comprises the following steps of mixing losartan potassium and hydroxypropyl methylcellulose, adding microcrystalline cellulose and pregelatinized starch, mixing, adding a proper amount of ethanol water solution, granulating, drying to obtain losartan potassium dry particles, and mixing amlodipine besylate and sodium carboxymethyl starch to obtain the amlodipine and losartan potassium compound composition; crushing losartan potassium, adding microcrystalline cellulose and pregelatinized starch, mixing to obtain amlodipine mixed powder, mixing losartan potassium dry particles, amlodipine mixed powder, silicon dioxide and magnesium stearate, tabletting, and coating so that the tablet obtained by the method is stable, and the dissolution rate of the tablet is close to or consistent with that of an original product on the market.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of a compound composition containing amlodipine besylate and losartan potassium, that is, a tablet. Background technique [0002] Amlodipine besylate is a new generation of calcium ion antagonists and the third generation of dihydropyridine long-acting calcium ion channel blockers, which can block the influx of extracellular calcium ions in cardiac muscle and vascular smooth muscle, and ease the long-term expansion of peripheral Blood vessels and coronary vessels, reducing vascular resistance, used for the treatment of various degrees of hypertension and the treatment of variant angina pectoris and stable angina pectoris. [0003] Losartan potassium is an angiotensin II receptor (AT1 type) antagonist, which can block various pharmacological effects (including promoting vasoconstriction, aldosterone release, etc.) produced by endogenous and exogen...

AI Technical Summary

Problems solved by technology

Dissolution rates that are too fast or too slow compared to the reference product may result in inconsistent in vivo efficacy with the reference product

[0007] Chinese patent CN101472587B discloses a pharmaceutical composition of amlodipine and losartan potassium and prepares it into the form of a double-layer tablet, although the double-layer tablet isolates amlodipine and losartan potassium, making the amlodipine Stability has been improved, but the process of preparing it into a double-layer tablet is complex and requires high equipment requirements, and the dissolution rate of losartan potassium in aqueous medium in 15 minutes reaches more than 85%, which is significantly higher than that of the losartan potassium reference The dissolution rate of the preparation (about 65% in 15 minutes) is fast, suggesting that it may not be equivalent to the reference preparation of losartan potassium

[0008] Chinese patent CN104394865B discloses a composition containing amlodipine and losartan with improved stability, which improves the stability of amlodipine by adding antioxidant propyl gallate, however, additional antioxidants may bring other Potential safety hazards

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