A kind of double-layer osmotic pump controlled-release tablet containing melatonin and its preparation method

Abstract

The invention relates to a melatonin-containing double-layered osmotic pump controlled release tablet and a preparation method thereof. The melatonin-containing double-layered osmotic pump controlled release tablet comprises an osmotic pump basic tablet and a moistureproof protective membrane at the outer layer of the basic tablet, wherein the osmotic pump basic tablet comprises a double-layered tablet core and a coating semipermeable membrane; the semipermeable membrane layer covers the outer surface of the double-layered tablet core; the upper layer of the double-layered tablet core serves as a melatonin-containing drug layer, while the lower layer serves as a driving layer containing an osmotic pressure active substance; a drug release hole is formed in the semipermeable membrane. The melatonin-containing double-layered osmotic pump controlled release tablet and the preparation method disclosed by the invention have the benefits that the double-layered osmotic pump controlled release technology is adopted, when the controlled release tablet is taken, the tablet can absorb moisture in gastric juice, and the tablet core driving layer generates a large osmotic pressure to continuously and strongly push out the drug from the hole in the semipermeable membrane until the driving layer occupies the whole space in the semipermeable membrane, so that compared to the single-layered tablet, the controllability of the drug is better, and the availability is higher; the tablet can be clinically used for promoting sleep, regulating sleep quality, increasing immunity, resisting aging and the like.

Description

technical field [0001] The invention relates to a drug controlled-release preparation, in particular to a double-layer osmotic pump controlled-release tablet containing melatonin and a preparation method thereof. Background technique [0002] Melatonin is an indole hormone secreted by the pineal gland of humans and animals. It has a wide range of physiological activities and can control and coordinate the human immune system, nervous system, endocrine system, and reproductive system. It has anti-stress, anti-lipid Peroxidation, involved in activities such as sedative, hypnotic, analgesic and interest-free effects. At home and abroad, it has been widely used as a healthy food for anti-aging, enhancing immunity, preventing cardiovascular diseases, cancer and various senile diseases, maintaining normal sexual function, and improving sleep. [0003] With the growth of age, the melatonin secreted by the body decreases significantly, with an average decrease of 10-15% every 10 ye...

AI Technical Summary

Problems solved by technology

[0004] However, since the biological half-life of melatonin is very short, only about 35 minutes, to maintain a suitable duration of action, it needs to be prepared as a controlled release preparation

At present, there is no controlled-release preparation containing melatonin on the market. Chinese patent CN1195525A describes an erosion-type sustained-release preparation containing melatonin. The release data of the preparation is not given, and the sustained-release preparation usually cannot be accurately pressed. The "zero-order" drug-time curve releases drugs stably, especially for sustained-release preparations such as erosion type and matrix type. After taking them, the surface is affected by gastric juice and food wrapping, and the drug release rate will be greatly disturbed.

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