Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

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

A technology of melatonin and controlled-release tablets, which can be used in medical preparations containing active ingredients, drug delivery, organic active ingredients, etc. , the effect of prolonged sleep time

Inactive Publication Date: 2005-07-13
CHONGQING TAIJI MEDICAL RES INST CO LTD
View PDF0 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Both of these are not good enough to meet the needs of patients

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] 1) Preparation of melatonin immediate-release layer:

[0019] Prescription (based on 1000 grams): melatonin 3%, vitamin B 6 10%, lactose 40%, pregelatinized starch 42%, hypromellose 1%, magnesium stearate 1%, silicon dioxide 3%.

[0020] making process:

[0021] Weigh melatonin and lactose and mix them evenly in equal increments, then weigh vitamin B 6 , pregelatinized starch, all mixed evenly; add hypromellose solution, make soft materials according to conventional methods and granulate with a 12-20 mesh sieve; dry at 30-70°C; granulate with a 12-20 mesh sieve; Mix silicon and magnesium stearate; obtain immediate-release layer granules.

[0022] 2) Preparation of melatonin slow-release layer:

[0023] Prescription (based on 1000 grams): melatonin 2.5%, hypromellose 30%, stearic acid 30%, polyethylene glycol 10000 36.5%, magnesium stearate 1%.

[0024] making process:

[0025] Put stearic acid and polyethylene glycol 10000 in a container, heat it in a water bath ...

Embodiment 2

[0034] 1) Based on a total weight of 1000 grams, weigh 2% of melatonin and 10-50% of powdered sugar and mix evenly by equal addition method, and weigh vitamin B 6 14%, microcrystalline cellulose 10-50%, all mixed evenly; add polyvinylpyrrolidone 0.003%-3%, concentration 2-5%, make soft material; 12-30 mesh sieve granulation; 30-70 ℃ drying; 12-20 mesh granules; add 1-3% talcum powder, 0.2-2% magnesium stearate and mix evenly; obtain immediate-release layer granules (1).

[0035] 2) Based on the total weight of 1000 grams, put poloxamer 10-40%, polyethylene glycol 6000 30-50% in a container, heat in a water bath to 70-90°C, and melt into a solution; add melatonin 3% and dissolve into a solution; then add 0.03-3% hypromellose and stir well; take out and cool; granulate with a 12-20 mesh sieve; finally add 0.2-2% magnesium stearate and mix well; obtain a slow-release layer particles (2).

[0036] 3) Adjust the tablet weight of the immediate-release layer granules (1) to 0.06-0...

Embodiment 3

[0039] 1) Based on a total weight of 1000 grams, take by weighing 1.5% of melatonin, 2% of silicon dioxide, and 4.5% of carboxymethyl starch and mix uniformly by equal addition method; then weigh vitamin B 6 10%, microcrystalline cellulose 30%, pregelatinized starch 50%, all mixed evenly; add hypromellose liquid 25ml (concentration 2-5%), make soft material; 12-30 mesh sieve granulation; 30 Dry at -70°C; granulate into 12-20 meshes; add 3% talcum powder and 1% magnesium stearate and mix evenly; obtain immediate-release layer granules (1).

[0040] 2) Based on a total weight of 1000 grams, put poloxamer 50%, polyethylene glycol 6000 30%, and polyoxyethylene (40) 10% in a container, heat it in a water bath to 70-90°C, and melt it into a solution; add Melatonin 3% and dissolved into a solution; then add poloxamer 5% and stir well; take out and cool; use 12-20 mesh sieve to granulate; finally add magnesium stearate 2% and mix well; obtain a slow-release layer particles (2).

[...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

Melatonin double-layer controlled-release tablet and its preparation process, which uses melatonin as the main raw material, and is a double-layer tablet composed of an immediate-release layer and a sustained-release layer. The composition of the immediate-release layer is: 1-5% melatonin , Vitamin B 6 3-15%, lactose 10%-70%, pregelatinized starch 10%-70%, hypromellose 1%, magnesium stearate 0.3%-2%, silicon dioxide 1.0%-3.0%; The composition of release layer is: melatonin 2-6%, hypromellose 15%-60%, stearic acid 15%-65%, polyethylene glycol 10000 10%-30%, magnesium stearate 1.0% %—5.0%. For the first time, this variety uses a double-layer tablet of quick release + sustained release, which makes this product have a rapid hypnotic effect and the effect of prolonging the effective sleep time, which can make up for the short hypnotic time or slow onset of existing melatonin products on the market. shortcoming.

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. Background technique [0002] Melatonin (melatonin 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...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K31/4045A61P25/20A61P37/04
Inventor 张涛张旭曾志杨勇邓履江陈兰
Owner CHONGQING TAIJI MEDICAL RES INST CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com