Amitriptyline hydrochloride tablet and preparation method thereof

Abstract

The invention discloses an amitriptyline hydrochloride tablet, which is prepared from the following components in percentage by weight: 35 to 40 percent of amitriptyline hydrochloride, 25 to 30 percent of corn starch, 5 to 8 percent of dextrin, 5 to 8 percent of pregelatinized starch, 8 to 10 percent of calcium hydrogen phosphate, 6 to 8 percent of saccharose, 0.5 to 1 percent of hydroxypropyl methyl cellulose, 1 to 3 percent of low-substituted hydroxypropyl cellulose, 1 to 3 percent of silicon dioxide, 0.5 to 2 percent of amomum powder, 0.5 to 1 percent of carboxymethyl starch sodium, 0.5 to1 percent of magnesium stearate and 1 to 2 percent of a coating premix. On the basis of existing raw materials, the silicon dioxide and the amomum powder are added; a research shows that the obtainedamitriptyline hydrochloride tablet is stable and can be quickly dissolved and take a quick response; the drug use safety and effectiveness are improved; the occurrence rate of adverse reaction is avoided.

Description

Technical field [0001] The invention belongs to the technical field of medicines, and specifically relates to an amitriptyline hydrochloride tablet and a preparation method thereof. Background technique [0002] Amitriptyline hydrochloride, alias is N,N-dimethyl-3-[10,11-dihydro-5H-dibenzo(a,d)cycloheptatrien-5-ylidene]-1-propylamine Hydrochloride is one of the antidepressants currently used for primary insomnia. It belongs to the tricyclic antidepressants. It mainly acts by blocking the reabsorption of norepinephrine and serotonin. It can also block Neurotransmitters such as acetylcholine and histamine. In addition, amitriptyline hydrochloride can also be used to treat children's ADHD in pediatric treatment. The dose for adults is generally 200 mg, while for patients with primary insomnia, the general dose is 10-25 mg; for patients with depression, you can only know whether this medicine is effective for you after taking the medicine for more than three weeks. Therefore, pati...

AI Technical Summary

Problems solved by technology

Clinically, the drug is required to dissolve quickly and take effect quickly, which requires the use of appropriate prescriptions and processes in the production of preparations to improve the dissolution rate of the drug. However, it is difficult for the amitriptyline hydrochloride tablets prepared by the existing methods to achieve rapid dissolution and rapid onset. effect, and the obtained tablet is unstable, easily broken, and the disintegration time of the tablet is long, which cannot meet the ideal requirements

[0004] In the prior art, when using a wet method to make pharmaceutical tablets, hydroxypropyl methylcellulose as a binder is often made into a solution and then mixed with other raw materials, such as patent application number CN 201610037015.4 a kind of rasagiline In tablet and patent application number CN 201710133763.7 lurasidone hydrochloride tablet and its preparation method, hydroxypropyl methylcellulose is made into hydroxypropyl methylcellulose aqueous solution, the operation is complicated, the production efficiency is low, and the obtained The drug tablet is unstable and the dissolution rate is slow