A kind of osmotic pump controlled-release tablet containing melatonin and preparation method thereof

An osmotic pump controlled release, melatonin technology, applied in the directions of medical preparations containing active ingredients, medical preparations with non-active ingredients, pharmaceutical formulas, etc. Drug release rate interference and other issues to achieve the effect of enhancing immunity, ensuring sleep time, and improving sleep quality

Active Publication Date: 2017-08-25
CHANGZHOU ORFAMA PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] 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.

Method used

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  • A kind of osmotic pump controlled-release tablet containing melatonin and preparation method thereof
  • A kind of osmotic pump controlled-release tablet containing melatonin and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Such as figure 1 As shown, the melatonin-containing osmotic pump controlled release tablet according to the embodiment of the present invention is composed of an osmotic pump element tablet and an outer moisture-proof protective film, wherein the osmotic pump element tablet includes a tablet core 1, a semi-permeable membrane 2. The outer surface of the tablet core 1 is wrapped with a semi-permeable membrane 2 and a drug-releasing hole 3 is added to the semi-permeable membrane 2. The tablet core 1 is uniformly mixed with drugs and osmotic substances. The formula is as follows:

[0027] ① Taking the total weight of each piece as 100% as an example, the piece core 1 is composed of the following percentage materials:

[0028] Melatonin 1.37%, lactose 82.42%, starch 9.16%, PEO (5 million) 0.46%, polyvinylpyrrolidone (PVP K30) 5.60%, magnesium stearate (1%) 0.99%, and an additional amount of 95% ethanol ; The total weight is 218.40mg;

[0029] ② Taking the total weight of each tabl...

Embodiment 2

[0034] Such as figure 1 As shown, the melatonin-containing osmotic pump controlled release tablet according to the embodiment of the present invention is composed of an osmotic pump element tablet and an outer moisture-proof protective film, wherein the osmotic pump element tablet includes a tablet core 1, a semi-permeable membrane 2. The outer surface of the tablet core 1 is wrapped with a semi-permeable membrane 2 and a drug-releasing hole 3 is added to the semi-permeable membrane 2. The tablet core 1 is uniformly mixed with drugs and osmotic substances. The formula is as follows:

[0035] ① Taking the total weight of each piece as 100% as an example, the piece core 1 is composed of the following percentage materials:

[0036] Melatonin 1.37%, sodium chloride 24.73%, lactose 57.69%, starch 9.16%, PEO (5 million) 0.46%, polyvinylpyrrolidone (PVP K30) 5.60%, magnesium stearate (1%) 0.99% and extra Add an appropriate amount of 95% ethanol; the total weight is 218.40mg;

[0037] ② Tak...

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Abstract

The invention relates to an osmotic pump controlled-release tablet containing melatonin and a preparation method thereof. The osmotic pump tablet is composed of an osmotic pump tablet and a moisture-proof protective film on its outer layer. Melanin 1.37%, lactose 82.42%, starch 9.16%, PEO 0.46%, polyvinylpyrrolidone 5.60%, magnesium stearate 0.99%; moisture-proof coating liquid consists of melatonin 3.9%, IV acrylic resin 5.5%, talc Powder 1.1%, magnesium stearate 1.1%, ethanol 88.4%. The beneficial effects of the present invention are: the controlled-release tablet provides melatonin to the human body, rapidly releases 1-6 mg within a few minutes after taking it, prompts the user to fall asleep quickly, and then releases continuously and stably for 6-10 hours, releasing about 0.1-0.6 mg per hour mg, to improve sleep quality, for enhancing immunity, anti-aging, etc.

Description

Technical field [0001] The invention relates to a drug controlled release preparation, in particular to a melatonin-containing osmotic pump controlled release tablet 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. It can control and coordinate the human immune system, nervous system, endocrine system, and reproductive system. It has anti-stress and anti-lipid properties. Peroxidation, participate in activities such as sedation, hypnosis, analgesia and interest-free effects. It has been widely used at home and abroad as healthy food for anti-aging, enhancing immunity, preventing cardiovascular disease, cancer and various senile diseases, maintaining normal sexual function, and improving sleep. [0003] The biosynthesis of melatonin is restricted by the photoperiod. The pineal gland is converted from tryptophan to 5-hydroxytryptophan un...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/44A61K31/4045A61K47/38A61K47/32A61P25/20A61P37/04A61P39/06
Inventor 马建国赵昱李贝贝王奕兰桑泽延
Owner CHANGZHOU ORFAMA PHARM TECH CO LTD
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