Preparation method and application method for melatonin dropping pill

A technology of melatonin and dripping pills, which is applied in the field of new pharmaceutical preparations, can solve the problems of first-pass effect, melatonin can not quickly enter the brain and take effect, and achieve the effect of shortening the drug dose and improving sleep

Inactive Publication Date: 2016-06-15
刘佳迪
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, melatonin preparations currently produced and used in China, such as oral liquids, capsules, etc., are digested and metabolized first after being swallowed and administered, which has a first-pass effect, and melatonin cannot all enter the brain quickly and take effect
Although melatonin lozenges can avoid the first-pass effect, there is no domestic production of foreign products

Method used

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  • Preparation method and application method for melatonin dropping pill
  • Preparation method and application method for melatonin dropping pill

Examples

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Embodiment Construction

[0009] Taking melatonin drop pills with a weight of 30 mg and each pill containing 1.0 mg of melatonin as an example, a preparation method and administration method of melatonin drop pills are given:

[0010] prescription:

[0011] Melatonin 1.0g

[0012] PEG4006.0g

[0013] PEG600023.0 g

[0014] Total 30.0 grams

[0015] Preparation method: take 1.0 g of melatonin fine powder, add 6.0 g of PEG4000, stir well to dissolve; take another 23.0 g of PEG60000, heat it on a water bath to melt, add it to the PEG400 solution of melatonin fine powder, stir , mix well. Put this mixture as a raw material in a dropping pill machine, keep the temperature at 65±2°C, and drop 30 mg per pill into liquid paraffin in an ice-water bath to condense. After taking it out, dry the liquid paraffin on the surface of the dropping pills with filter paper at a room temperature of about 25°C to obtain the product.

[0016] The obtained melatonin drop pills should be stored at room temperature in a s...

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Abstract

Directed at the current situation of no buccal melatonin preparation in China, the invention discloses preparation of a buccal melatonin dropping pill. The prepared dropping pill weighs 0.01 to 0.09 g (i.e., 10 to 90 mg) and contains 1.0 to 6.0 mg of melatonin. The application method for melatonin dropping pill is to keep one or more melatonin dropping pills in the mouth in 10 to 60 min before sleeping and allow the pills to naturally thaw before sleeping. According to the invention, the first pass effect of oral administration of a melatonin oral liquid or melatonin capsule is prevented, and sleep can be rapidly improved by using a small dosage of the melatonin dropping pill. The properties, dissolving and dispersion limits, stability and other indexes of the melatonin dropping pill prepared in the invention accord with related requirements for dropping pills prescribed in Chinese Pharmacopeia.

Description

technical field [0001] The invention relates to a new pharmaceutical preparation. Background technique [0002] Melatonin (melatonin, melatonin) has the effect of improving sleep, and the action site is in the brain. However, melatonin preparations currently produced and used in China, such as oral liquids and capsules, are digested and metabolized first after being swallowed and administered, which has a first-pass effect, and melatonin cannot all enter the brain quickly and take effect. Although melatonin lozenges can avoid the first-pass effect, there is no domestic production of foreign products. In my country, the drop pill preparation technology is mature, and its basic requirements refer to the drop pill under the second appendix IH pill item of "Pharmacopoeia of the People's Republic of China" in 2010. Dropping pills can be swallowed and administered, and the drug can be absorbed through the oral mucosa to avoid the first-pass effect. For example, Compound Danshen...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4045A61K47/34A61P25/20
Inventor 刘佳迪
Owner 刘佳迪
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