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Melatonin orally disintegrating tablet and preparation method thereof

An oral disintegrating tablet, melatonin technology, applied in the directions of pharmaceutical formulation, drug delivery, pill delivery, etc., can solve problems such as no related reports, and achieve improved bioavailability, short production cycle, and short disintegration time. Effect

Inactive Publication Date: 2012-01-25
徐贵丽 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, making melatonin into orally disintegrating tablets has extensive clinical significance and market prospects, but there are no related reports in the prior art.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Weigh 3 parts of melatonin, 6 parts of microcrystalline cellulose (SMCC), 8 parts of cross-linked polyvinylpyrrolidone (PVPP), 8.18 parts of sodium bicarbonate (NaHCO3), 9.82 parts of sodium citrate, 2.5 parts of lemon essence, 0.75 parts of aspartame, 2 parts of magnesium stearate, 59.75 parts of mannitol for later use. Grind each raw material separately, pass through a 80-mesh sieve, and dry at 50°C. Mix the raw materials evenly by the equal-volume incremental method, and pass through a 60-mesh sieve; use the direct tableting method to weigh the mixed powder Press into tablets, and the average tablet weight is set at 100 mg to obtain melatonin orally disintegrating tablets.

[0029] It has been determined that the hardness of the disintegrating tablet is between 14 and 16 Newtons; the disintegration time in vivo is between 25 and 28 seconds; the dissolution rate in artificial gastric juice and intestinal juice at 37°C in 1 minute is 40%, and the dissolution rate in 6 ...

Embodiment 2

[0031] Weigh 3 parts of melatonin, 3 parts of microcrystalline cellulose (SMCC), 13 parts of cross-linked polyvinylpyrrolidone (PVPP), 10 parts of sodium bicarbonate (NaHCO3), 12 parts of sodium citrate, 2.5 parts of lemon essence, 0.75 parts of aspartame, 2 parts of magnesium stearate, 53.75 parts of mannitol for later use. Grind each raw material separately, pass through a 80-mesh sieve, and dry at 60°C. Mix the raw materials evenly by the equal-volume incremental method, and pass through a 60-mesh sieve; use the direct compression method to weigh the mixed powder. Press into tablets, and the average tablet weight is set at 100 mg to obtain melatonin orally disintegrating tablets.

[0032] It has been determined that the hardness of the disintegrating tablet is between 14 and 16 Newtons; the disintegration time in vivo is between 28 and 30 seconds; the dissolution rate in artificial gastric juice and intestinal juice at 37°C in 1 minute is 30%, and the dissolution rate in 6 ...

Embodiment 3

[0034] Weigh 3 parts of melatonin, 9 parts of microcrystalline cellulose (SMCC), 5 parts of cross-linked polyvinylpyrrolidone (PVPP), 8.18 parts of sodium bicarbonate (NaHCO3), 9.82 parts of sodium citrate, 2 parts of lemon essence, 1.25 parts of aspartame, 2 parts of magnesium stearate, 59.75 parts of mannitol for later use. Grind each raw material separately, pass through a 80-mesh sieve, and dry at 70°C. Mix the raw materials evenly by the equal-volume incremental method, and pass through a 60-mesh sieve; use the direct tableting method to weigh the mixed powder. Press into tablets, and the average tablet weight is set at 100 mg to obtain melatonin orally disintegrating tablets.

[0035] It has been determined that the hardness of the disintegrating tablet is between 14 and 16 Newtons; the disintegration time in vivo is between 24 and 28 seconds; the dissolution rate in artificial gastric juice and intestinal juice at 37°C in 1 minute is 35%, and the dissolution rate in 6 m...

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Abstract

The invention discloses an oral disintegrating tablet of melatonin which is made by selecting the melatonin, a disintegrator, an effervescing agent, a filling agent, an odor corrective and a lubricating agent for smashing, drying, mixing and tablet forming. The drug can be promptly disintegrated inside the mouth without water and is especially applicable to the patients with the deglutition difficulty or under the special environment, such as the elder, the children, the narcose patient etc. The drug also has good effect when used in the environment, which lacks the water, such as the outdoors, the battle field etc. The invention has simple technology and cheap cost and is provided with the advantages of short production period, simple production equipment etc. The oral disintegrating tablet which is prepared by the method of the invention has the enough rigidity to meet the requirements of the production, the packaging, the storage and the transportation, and at the same time the oral disintegrating tablet has good taste and short disintegrating time, and the inside-body disintegrating time is less than thirty seconds; the dissolved quantity inside the 37 DEG C artificial gastricjuice and intestinal juice within one minute is 40 percent, and the dissolved quantity within six minutes is as high as 90 percent.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical production, and in particular relates to a melatonin orally disintegrating tablet and a preparation method thereof. Background technique [0002] Insomnia is a common sleep disorder characterized by difficulty falling asleep and maintaining sleep. Long-term insomnia can seriously affect people's normal life, work and study. Currently, insomnia is caused by mental stress, busy work and study, long-term irregular rest and sleep, bad environment, family conflicts, disharmonious interpersonal relationships, various setbacks in life, and negative emotional experiences caused by long-term psychological conflicts and trauma. There are more and more patients. [0003] Melatonin, whose chemical name is N-acetyl-5-methoxytryptamine, is an indole hormone secreted by the pineal gland of mammals. It has the pharmacological effects of anti-stress, anti-lipid peroxidation, anti-aging, inducing sleep, e...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/46A61K31/4045A61P25/20
Inventor 徐贵丽贺建昌顾胜华张青王慧敏
Owner 徐贵丽
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