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

A technology for melatonin and controlled-release tablets, which is used in medical preparations containing active ingredients, drug delivery, organic active ingredients, etc., can solve the problem of not being able to meet the needs of patients well, and achieve rapid hypnotic effects and prolonged sleep time. , The effect of long-term supply and marketing

Inactive Publication Date: 2004-04-14
CHONGQING TAIJI MEDICAL RES INST CO LTD
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  • 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

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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%, polyvinyl alcohol 6000 30-50% in a container, heat it in a water bath to 70-90°C, and melt it into a solution; add 3% melatonin 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 sustained-release layer granules (2).

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

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) Put 50% of poloxamer, 30% of polyvinyl alcohol 6000, and 10% of polyoxyethylene (40) in a container based on a total weight of 1000 grams, heat it in a water bath to 70-90°C, and melt it into a solution; Melanin 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 sustained-release layer granules (2).

...

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PUM

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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...

Claims

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Application Information

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Patent Type & Authority Applications(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
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