Levamlodipine oral disintegrating tablet formulation and its preparing method

Abstract

The present invention discloses a levoamlodipine oral disintegrating tablet preparation and its preparation method. It is made up by using levoamlodipine or its active salt as main medicine, using other ingredients as auxiliary material and adding stabilizing agent, for example citric acid, ascorbic acid, lactic acid, benzenesulfonic acid or maleic acid through a certain preparation process. Besides, said invention also provides the concrete steps of its preparation process.

Description

technical field [0001] The invention relates to a drug orally disintegrating tablet for treating hypertension and angina pectoris, in particular to a levoamlodipine orally disintegrating tablet preparation and a preparation method thereof. technical background [0002] Cardiovascular disease is the number one killer threatening human health, and hypertension is one of the most common diseases. Epidemiological studies show that there are currently 600 million hypertensive patients in the world, and the prevalence of hypertension is about 10%. The national prevalence rate of hypertension is about 12%, and it is as high as 20% in some developed countries in Europe and America. According to national statistics, the number of hypertensive patients in my country has reached 100 million, and more than 3 million people are newly added every year. Hypertension will be a major public health problem facing our country. Complications of hypertension such as s...

AI Technical Summary

Problems solved by technology

The principle of the foaming agent is to add strong alkaline sodium carbonate or sodium bicarbonate and some acidic compounds to the preparation. These compounds must coexist in the absence of water. However, this technical solution adopts general wet mixing granulation to prepare Its tablet, so it ignores the most essential requirements of the drug, that is, the stability and uniformity of the drug

[0006] First of all, levamlodipine generally exists in the form of active salts, and the best active salts are besylate and maleate, both of which are weakly acidic. It will lose its activity and produce related substances with side effects; secondly, the activity of levamlodipine is very strong, and the dosage commonly used in clinical practice is only a few milligrams. The general preparation process is difficult to ensure the uniformity of the main drug through simple material mixing. , leading to inaccurate doses of medications taken by patients