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Melatonin delayed release tablet and preparation method thereof

A melatonin and delayed-release technology is applied in the field of melatonin delayed-release tablets and the preparation thereof, which can solve the problems of inhibiting male gonad development, excessive administration dose, endocrine disorder, etc., and achieves a simple preparation process and a reduction in the dosage of medication. , the effect of maintaining complete sleep

Inactive Publication Date: 2019-02-19
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] For the treatment of this type of early-awakening insomnia, sedative-hypnotics are mostly used clinically at present, which has obvious limitations: 1. The specificity for different types of insomnia is not strong, and most of the indications are various insomnias. And the side effects are relatively large; two, lack of time pertinence, difficulty in falling asleep, nocturnal awakening and early awakening have different time requirements for hypnotic drugs, and current drugs are taken before going to bed for different types of insomnia. There is still a certain blood drug concentration in the body at the stage of forced hypnosis, accompanied by long-term side effects; 3. The dose is not targeted enough, the same dose can treat different types of insomnia, and it is impossible to prescribe the right medicine
In recent years, with the discovery of the important role of melatonin in sleep maintenance, and because of its short half-life, there is basically no residual effect in the morning, and it has obvious advantages in improving sleep, and the development of related preparations has attracted increasing attention. Melanin preparations are mainly ordinary tablets and sustained-release tablets, and there are still some problems, such as excessive dosage and insufficient pertinence of the aforementioned treatment and administration.
Even though melatonin triggers a natural drowsy state compared to traditional hypnotics, without the significant side effects of traditional hypnotics, but because melatonin also has the effect of regulating endocrine, abuse or long-term improper use can also lead to endocrine disorders, serious The situation can even lead to female infertility and inhibit male gonad development, so more and more scholars and institutions call for the targeted and timely use of melatonin

Method used

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  • Melatonin delayed release tablet and preparation method thereof
  • Melatonin delayed release tablet and preparation method thereof
  • Melatonin delayed release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040]

[0041] Preparation Process:

[0042] (1) Preparation of double-layer tablet cores: Take the prescribed amount of tablet core drug-containing layer melatonin, lactose and behenic acid ester and pass through 80 mesh sieves respectively, mix well, add 10% starch slurry to make soft materials, and 30 mesh sieves granules, dried at 50°C for 2 hours, granulated with a 25-mesh sieve, mixed with micro-powdered silica gel; take the prescribed amount of tablet core expansion layer and each auxiliary material was passed through an 80-mesh sieve, mixed evenly, and added with 5% PVPK30 aqueous solution to make a soft material, 30 mesh Sieve to granulate, dry at 50°C for 2 hours, sieve through a 25-mesh sieve, add magnesium stearate and mix evenly; press to obtain a double-layer tablet core;

[0043] (2) Preparation of coated granules: take the prescription amount of HPMC 100LV and lactose and pass through a 60-mesh sieve respectively, mix well, add 95% ethanol as a binder to ma...

Embodiment 2

[0046]

[0047] Preparation Process:

[0048] (1) Preparation of double-layer tablet core: take the prescribed amount of tablet core drug-containing layer melatonin, EC and lactose and pass through 80 mesh sieve respectively, mix well, make soft material with 75% ethanol, granulate with 30 mesh sieve, at 50 ℃ Dry for 1 hour, granulate with a 25-mesh sieve, add magnesium stearate and mix evenly; take the prescription amount of each auxiliary material of the tablet core expansion layer and pass through an 80-mesh sieve, mix evenly, add 10% starch slurry to make a soft material, and granulate with a 30-mesh sieve , dried at 50°C for 2 hours, sieved with a 25-mesh sieve, mixed with stearic acid; pressed to obtain a double-layer tablet core;

[0049] (2) Preparation of coated granules: Take the prescribed amount of behenate, lactose and calcium hydrogen phosphate, pass through a 60-mesh sieve respectively, mix well, add 10% PVPK30 solution as a binder to make a soft material, an...

Embodiment 3

[0052]

[0053] Preparation Process:

[0054] (1) Preparation of double-layer tablet core: take the raw and auxiliary materials of the drug-containing layer of the tablet core and the auxiliary materials of the expansion layer of the tablet core to pass through an 80-mesh sieve respectively, fully mix the components of each layer, and press to obtain a double-layer tablet core;

[0055] (2) Preparation of coated granules: take the prescription amount of glyceryl monostearate, beeswax, and mannitol and mix, heat and melt, cool to room temperature and solidify, grind and pulverize, pass through a 30-mesh sieve, add talcum powder and mix, and set aside;

[0056] (3) Press coated tablets: first add half of the coated granules to the bottom of the die, place the double-layer tablet core in the center, then add the remaining half of the coated granules, and press to get the tablet.

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Abstract

The invention belongs to the field of pharmaceutic preparations, and relates to a melatonin delayed release tablet and a preparation method thereof. The delayed release tablet is composed of a double-layer tablet core and a compression coating which covers around the tablet core and plays a role of time lag. The double-layer tablet core comprises a medicated controlled release layer and a swellinglayer, wherein the swelling layer can be obviously swelled when wet so as to cooperate with the coating to regulate the drug-release starting point. After a patient orally takes the preparation, dueto the existence of the retardant coating, a drug is not released immediately, but after a certain time, the internal swelling layer is obviously swelled when wet to result in fracture of the coating,the medicated layer is exposed, and the controlled-release skeleton regulates release of the drug. The melatonin delayed release tablet has the advantages that the melatonin preparation has the functions of delayed release and controlled release, and the preparation method for the melatonin preparation is provided.

Description

technical field [0001] The invention relates to a melatonin delayed-release tablet and a preparation method thereof, belonging to the field of pharmaceutical preparations. The purpose is to use melatonin as a model drug to provide a preparation that starts to release the drug after a 3-hour lag and can exert a sustained release of the drug for 4-5 hours. Background technique [0002] Sleep is an essential content in human life. Its importance is just as stated in a report by the World Health Organization, "Sleep, like air, food, and water, is a basic necessity for human life." Not getting enough sleep can damage one's health and cause other problems as well. According to the survey data of the Chinese Medical Association, the prevalence rate of sleep disorders in my country reaches 42.7%, and about 300 million middle-aged people suffer from sleep disorders. Insomnia has a great impact on both the individual and the society, which is reflected in the increase in the cost o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/42A61K9/30A61K47/38A61K47/32A61K47/14A61K47/44A61K31/4045A61P25/20
CPCA61K9/2013A61K9/2027A61K9/2054A61K9/2059A61K9/282A61K9/2866A61K31/4045A61P25/20
Inventor 周卫周玉洁冯雅倩
Owner CHINA PHARM UNIV
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