A kind of agomelatine tablet and preparation method thereof

Abstract

The invention discloses an agomelatine tablet of which the formula comprises the following components by weight: 25g of agomelatine crystal form II, 55-70g of lactose, 13-30g of starch, 6-12g of povidone K30, 5-10g of carboxymethyl starch sodium, 1-3g of stearic acid, 0.5-1.5g of magnesium stearate, 0.1-0.5g of silicon dioxide, 4-6g of coating powder, 70-90g of 75% ethanol, 1-2g of potassium gluconate, 1-2g of arabic gum and 1-2g of magnesium citrate. The potassium gluconate, Arabic gum and magnesium citrate are added into the formula of the agomelatine tablet provided by the invention to adjust the dissolution rate of the tablet, so that the coated tablet has good dissolution behavior and stronger stability.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical compositions, in particular to an agomelatine tablet and a preparation method thereof. Background technique [0002] Agomelatine is a melatonin 1, 2 (MT1, MT2) receptor agonist, but also a 5-hydroxytryptamine 2c (5HT2C) receptor antagonist, which can directly bind to the 5HT2C receptor of the post-synaptic membrane of the nerve, thereby exerting It has antidepressant effect and does not increase the concentration of 5HT in the synapse, so it does not have the common side effects of serotonin reuptake inhibitor drugs and serotonin norepinephrine reuptake inhibitor drugs. Another unique target of the drug is the MT receptor. Through the agonistic effect on the MT1 and MT2 receptors, it can treat the following diseases such as tension, fatigue, sleep disturbance and anxiety, major depression, seasonal affective disorder, cardiovascular disease , digestive disorders, insomnia and fatigue due t...

AI Technical Summary

Problems solved by technology

After research, it is found that the dissolution rate of marketed products in China and Europe is relatively large, and individual differences are obvious, which affects the therapeutic effect. The prior art CN101732296A, CN102342924A, and CN102552188A also try to improve on the basis of marketed product prescriptions, and also use lactose and corn starch , sodium carboxymethyl starch, stearic acid, magnesium stearate, etc. are used as auxiliary materials to prepare agomelatine tablets, to solve the problem of poor dissolution, through the inventor's research, it has been found that lactose and starch are used as fillers. The quality requirements are very high, and it is actually difficult to achieve the same dissolution effect as Valdoxan tablets with domestically produced lactose

[0004] For the above problems, the agomelatine tablet recorded in the disclosed invention patent CN201310219836 has a good dissolution effect; its good dissolution effect is mainly reflected in the time of 30min~60min, and its dissolution rate in 0~30min is relatively Poor, and the difference in the change of the dissolution rate is large, and the stability is poor