Itopride hydrochloride orally disintegrating tablets and preparation method thereof

Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to an orally disintegrating itopride hydrochloride tablet and a preparation method thereof: 50 parts by weight of itopride hydrochloride, 90-110 parts by weight of mannitol, and 10-30 parts by weight of lemon Acid, 30-40 parts by weight of polyvinylpyrrolidone and an appropriate amount of 50% ethanol solution are mixed evenly and added to the above-mentioned mixed material powder, 10-30 parts by weight of citric acid and stevioside are mixed in an appropriate amount to make a uniform soft material, and passed through 30 mesh Wet granules are prepared by nylon sieve, dried at 50-60°C for about 30 minutes, sieved with 30 meshes for granulation, the granules and 2-3 parts by weight of magnesium stearate and 1-2 parts by weight of micro-powdered silica gel are mixed evenly, and pressed into tablets. It can disintegrate quickly in the oral cavity under anhydrous conditions (or only a small amount of water exists), enter the digestive tract with swallowing action, and have no mucosal absorption in the oral cavity. The absorption and metabolism process in the body are consistent with ordinary tablets. Compared with common preparations, it has the advantages of convenient administration, fast absorption, high bioavailability, and less irritation to the mucous membrane of the digestive tract.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an orally disintegrating itopride hydrochloride tablet and a preparation method thereof. Background technique [0002] The chemical name of itopride hydrochloride is N-[4-[2-(dimethylamino)ethoxy]benzyl]-3,4-dimethoxybenzamide hydrochloride. In my country, raw materials and tablets were accepted for clinical research in 2000, and capsules and tablets were accepted for clinical research in 2001. Among them, raw materials and tablets were protected as national second-class new drugs in 2001. Itopride hydrochloride is the main component of commonly used digestive system drugs and gastrointestinal motility drugs. Pharmacological effects of itopride hydrochloride: It has dual effects of dopamine D2 receptor blockade and acetylcholinesterase inhibition, enhances gastric and duodenal motility by stimulating the release of endogenous acetylcholine and inhibiting its...

AI Technical Summary

Problems solved by technology

[0003] Common itopride hydrochloride preparations on the market are mostly capsules or tablets, but in the field of pediatrics and geriatric medicine, tablets and capsules are difficult to swallow, and the dosage form of capsules or tablets affects the compliance of drug treatment to a certain extent

Because ordinary tablets and capsules have to disintegrate in the stomach to release the drug, the onset of action is slow, and it is difficult to swallow due to their large size. It is not suitable for infants, critically ill patients and elderly patients. In the absence of water also difficult to take

Oral liquids and dispersible tablets have solved the above problems to a certain extent, but due to the characteristics of the dosage form, the preparation process is complicated, many auxiliary materials are used, energy consumption is large, and the cost is high.

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