Melatonin two-layer release-controlled tablet and preparing process thereof

Abstract

The invention is a melatonin double-layer controlled release tablet and making technique, using melatonin as main raw material, and composed of quick-release layer and sustained-release layer. The quick-release layerí»s components: melatonin 1-5%, Vitamin B6 3-15%, lactose 10-70%, pre-gel amylum 10-70%, hypromellose 0.03-0.3%, magnesium stearate 0.3-2% and SiO2 1.0-3.0%; the sustained layerí»s components: melatonin 2-6%, hypromellose 15-60%, stearic acid 15-65%, polyethylene glycol 10000 10-30%, and magnesium stearate 1.0-5.0%. It has efficacies of quickly hypnotizing and prolonging effective time of sleeping.

Description

technical field

[0001] The invention belongs to the technical field of melatonin products, and in particular relates to a melatonin double-layer controlled-release tablet and a preparation process. technical background

[0002] Melatonin (melatonon molecular formula is C 13 h 16 N 2 o 2 , the chemical name is N-acetyl-5-methoxytryptamine. It plays an important regulatory role in human growth and development, reproduction, and metabolism, and has the effects of sedative and hypnotic, enhancing immune function, prolonging life and inhibiting tumors. The dosage forms of the varieties listed at home and abroad are: ordinary tablets, capsules, and ordinary sustained-release tablets. Ordinary tablets and capsules have the characteristics of fast onset of action, but short maintenance time; general sustained-release tablets have the characteristics of long maintenance time, but slow onset of action. Neither of these are well suited to the patient's needs.

[0003] The purpos...