Itopride hydrochloride chewable tablets and preparation method thereof

Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to an itopride hydrochloride chewable tablet and a preparation method thereof: 50 parts by weight of itopride hydrochloride, 100-170 parts by weight of a filler, 20-40 parts by weight of citric acid, 3-8 parts by weight of polyvinylpyrrolidone and an appropriate amount of 50% ethanol solution are mixed and added to the above-mentioned mixed material powder, mixed to make a uniform soft material, passed through a 30-mesh nylon sieve to make wet granules, and dried at 50-60 ° C for about 30 minutes. The 30-mesh sieve is sized, and the granules are mixed with 2 to 3 parts by weight of magnesium stearate evenly and pressed into tablets. The filler is one or more of pregelatinized starch, lactose, dextrin, microcrystalline cellulose, mannitol, sorbitol and xylitol. It has the characteristics of simple preparation, convenient administration, fast absorption and high bioavailability.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an itopride hydrochloride chewable 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 hydrolysis, ...

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

Although orally disintegrating tablets and dispersible tablets solve the above problems to a certain extent, due to the characteristics of the dosage form, the preparation process is complicated, many excipients are used, the energy consumption is large, and the cost is high.

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