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Preparation method of melatonin controlled-release composition and preparation method of melatonin controlled-release tablet

A sustained-release composition, the technology of melatonin, applied in the direction of non-active ingredient medical preparations, drug delivery, pharmaceutical formulations, etc., can solve the unstable curative effect of melatonin sustained-release tablets, intermediates or sustained-release Uneven tablet content, small drug content, etc., to improve the phenomenon of easy adhesion to the inner wall of the metal, prevent uneven content of wet particles, and improve content uniformity

Inactive Publication Date: 2015-04-29
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the current preparations of melatonin sustained-release tablets contain a small amount of drug per tablet, and the melatonin raw material drug has strong adhesion, and it is easy to have uneven content of intermediates or sustained-release tablets during the process. This situation may lead to unstable efficacy of melatonin sustained-release tablets

Method used

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  • Preparation method of melatonin controlled-release composition and preparation method of melatonin controlled-release tablet
  • Preparation method of melatonin controlled-release composition and preparation method of melatonin controlled-release tablet
  • Preparation method of melatonin controlled-release composition and preparation method of melatonin controlled-release tablet

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Experimental program
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Effect test

Embodiment 1

[0048] The preparation of embodiment 1 Meiletonin sustained-release tablet

[0049]

[0050] Preparation method: weigh each raw and auxiliary material according to the prescription amount in batches of 10,000 tablets, mix melatonin and silicon dioxide evenly, sieve, and set aside. According to the order of lactose, microcrystalline cellulose, the mixture of melatonin and silicon dioxide, and HPMC K4M, the raw and auxiliary materials are added to the 4L pot of the Mini-CG high-speed mixing granulator, and the bottom slurry and side slurry are opened. Set the rotation speed of the bottom slurry to 400rpm, the rotation speed of the side slurry to 800rpm, and the protective air pressure of the bottom slurry and the side slurry are both 0.05MPa, and mix them. When mixing for 5min, 10min, and 15min respectively, in the upper, middle and lower three stages of the 4L granulation pot Samples were taken at each location, and a total of 9 samples were obtained, and the content uniform...

Embodiment 2

[0055] The preparation of embodiment 2 Meiletonin sustained-release tablets

[0056]

[0057] Preparation method: weigh each raw and auxiliary material according to the prescription amount in batches of 10,000 tablets, sieve and mix melatonin and silicon dioxide evenly, and set aside. According to the order of calcium hydrogen phosphate, microcrystalline cellulose, the mixture of melatonin and silicon dioxide, and HPMC K15M, the raw and auxiliary materials are sequentially added to the 4L pot of the Mini-CG high-speed mixing granulator, and the bottom pulp and side pulp are opened. Slurry, set the rotation speed of the bottom slurry to 400rpm, the rotation speed of the side slurry to 800rpm, the protection air pressure of the bottom slurry and the side slurry is 0.05MPa, mix, and when mixing for 5min, 10min, and 15min respectively, in the upper, middle, and The next three positions were sampled respectively, and a total of 9 samples were obtained, and the content uniformity...

Embodiment 3

[0062] The preparation of embodiment 3 Meiletonin sustained-release tablets

[0063]

[0064] Preparation method: weigh each raw and auxiliary material according to the prescription amount in batches of 10,000 tablets, mix melatonin and kaolin evenly, sieve, and set aside. According to the order of calcium hydrogen phosphate, mannitol, mixture of melatonin and kaolin, and sodium alginate, add the raw and auxiliary materials into the 4L pot of the Mini-CG high-speed mixing granulator, open the bottom slurry and side slurry, and set The rotation speed of the bottom slurry is 400rpm, the rotation speed of the side slurry is 800rpm, and the protection pressure of the bottom slurry and the side slurry are both 0.05MPa. Mix them. When mixing for 5min, 10min, and 15min, respectively, in the upper, middle, and lower parts of the 4L granulation pot, Samples were taken at each location, and a total of 9 samples were obtained to measure the content uniformity. After mixing, add ethan...

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Abstract

The invention relates to the field of drug preparation and in particular relates to a preparation method of a melatonin controlled-release composition and a preparation method of a melatonin controlled-release tablet. The preparation method of the melatonin controlled-release composition comprises the following steps: mixing melatonin with an anti-sticking agent, and sieving, thereby obtaining a bulk drug premix; respectively mixing a filling agent, the bulk drug premix and a controlled-release material, adding a wetting agent, carrying out wet granulation, and then mixing with a lubricating agent, so that the melatonin controlled-release composition is obtained. By adopting the preparation method of the melatonin controlled-release composition, the content uniformity of the main drug in the melatonin controlled-release tablet is obviously improved.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to a preparation method of a melatonin sustained-release composition and a preparation method of a melatonin sustained-release tablet. Background technique [0002] Melatonin, also known as melatonin, is the main hormone secreted by the pineal gland of vertebrates. Its biosynthesis and secretion have an obvious circadian rhythm, with decreased secretion during the day and increased secretion at night. Some literature called it "the chemical expression of the night". Melatonin has a regulatory effect on various endocrine activities, neural activities and behavioral functions through melatonin receptor mediation, and can regulate the circadian rhythm and seasonal reproduction function of photoperiod animals . In addition, Melatonin also has a wide range of physiological effects such as anti-tumor, anti-aging, immune regulation and scavenging free radicals. As a new type of pharm...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/4045A61K47/04A61K47/02A61K47/12
Inventor 左灵静陶安进马亚平袁建成
Owner HYBIO PHARMA
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