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Anti-insomnia composition, application of composition, multi-phase pulse immediate-release preparation prepared by use of composition and preparation method of preparation

A composition and pulse technology, applied in the field of medicine, can solve problems such as unspecified and controlled-release preparations with different release behaviors, dosage forms, prescriptions, processes, etc.

Active Publication Date: 2014-02-05
GUANGZHOU GONGHE MEDICINE TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, controlled-release preparations have different release behaviors, dosage forms, prescriptions, and processes, and the patent does not give a specific implementation, that is, the patent does not give the release behavior in vivo as attached figure 1 The specific implementation method of described controlled-release preparation

Method used

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  • Anti-insomnia composition, application of composition, multi-phase pulse immediate-release preparation prepared by use of composition and preparation method of preparation
  • Anti-insomnia composition, application of composition, multi-phase pulse immediate-release preparation prepared by use of composition and preparation method of preparation
  • Anti-insomnia composition, application of composition, multi-phase pulse immediate-release preparation prepared by use of composition and preparation method of preparation

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Experimental program
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Effect test

preparation example Construction

[0114] 8. The preparation method of the pellets of the two-phase pulsed release preparation:

[0115] Get the sudden release pellets 500g prepared by the preparation method of the release pellets of melatonin and parsley extract, dissolve in an appropriate amount of water with EC and triethyl citrate weight ratio 42:1, and adopt a fluidized bed Coating, the weight of the coating is increased to 50%, dried, and then coated with Eudragita L30D-55 and a suitable plasticizer, anti-adhesive agent using a fluidized bed to coat a layer of enteric coating, the weight of the coating is increased by 10%, and dried Second phase pulse burst release pellets available for biphasic pulse burst release formulations.

[0116] 9. The preparation method of the pellets of the three-phase pulsed release preparation:

[0117] Get 500g of release pellets prepared by the release pellet preparation method of 6, melatonin and Hypericum perforatum extract, be wrapped with carnauba wax, beeswax and sodi...

Embodiment 1

[0132] An anti-insomnia composition prepared by mixing melatonin, agomelatine and parsley extract, the melatonin is a melatonin solid dispersion, and the melatonin solid dispersion is a melatonin component and dispersion Polymer co-hot melt extrusion;

[0133] The parsley extract is prepared by the method of 3. extracting the parsley extract, and the melatonin solid dispersion is prepared by the method 1 of 1. preparing the solid dispersion by hot-melt extrusion of melatonin.

[0134] The two-phase pulse burst release preparation using the above-mentioned anti-insomnia composition includes the second phase pulse burst release pellets and the burst release pellets;

[0135] The instant-release pellets of this example are prepared by the preparation method of 7. Agomelatine and parsley extract instant-release pellets, and the second-phase pulse instant-release pellets are prepared by 8. The pellets of the two-phase pulse instant-release preparation The preparation method is pre...

Embodiment 2

[0139] An anti-insomnia composition, prepared by mixing melatonin and parsley extract, the melatonin is a melatonin solid dispersion, and the melatonin solid dispersion is a co-hot-melt extrusion of the melatonin component and the dispersion polymer out of formation;

[0140] The parsley extract is prepared by the method of 3. extracting the parsley extract, and the melatonin solid dispersion is prepared by the method 2 of 2. melatonin hot-melt extrusion for preparing the solid dispersion.

[0141] The biphasic pulse burst release preparation using the above-mentioned anti-insomnia composition, including the second phase pulse burst release pellets and the anti-insomnia composition of this embodiment;

[0142] The second-phase pulsed-release pellets are prepared by the preparation method of pellets of the two-phase pulsed-release preparation in 8.

[0143] The two-phase pulse release preparation is made into pellets;

[0144] The micropellets of this embodiment are prepared ...

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Abstract

The invention discloses an anti-insomnia composition, an application of the composition, a multi-phase pulse immediate-release preparation prepared by use of the composition and a preparation method of the preparation. The anti-insomnia composition consists of a component A and a component B, wherein the component A is one or more of melatonin, melatonin analogue and corresponding salt, melatonin receptor stimulant, 5-hydroxytryptamine 2C, receptor antagonist and 5-HTP (5-hydroxytryptophan); the component B is one or more of petroselinum neapolitanum extract, melissa extract, tuber fleeceflower stem extract, chamomile extract, passion flower extract, radix paeoniae alba extract, manyprickle acanthopanax extract, polygala tenuifolia extract, hyperforin perforatum extract, flos albiziae extract, lily extract and prunella vulgaris extract. The composition and the multi-phase pulse immediate-release preparation prepared by use of the composition have the characteristic of better anti-insomnia effect than a common melatonin preparation, and can effectively solve and improve the problem of difficult sleep of human or mammals while effectively solving and improving the insomnia problems such as light sleep or dreaminess or early awakening or difficult sleep after wakeup of human or mammals.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an anti-insomnia composition and its application, a multi-phase pulse burst preparation prepared by using the composition and a preparation method thereof. Background technique [0002] Insomnia is a common psychological disorder, which is primary or secondary to other physical and psychological diseases. It is an important health problem faced by human beings. Its incidence rate is about 30% in the world. According to the 2002 Global Insomnia Survey, 43.4% of Chinese people have experienced different degrees of insomnia in the past year (Li Shunwei, Wang Yuping, Wang Yongjun, etc. Expert consensus on definition, diagnosis and drug treatment of insomnia[J]. Chinese Journal of Neurology, 2006, 39 (2 ): 141). The World Health Organization has conducted surveys in 14 countries, and about 27% of people have sleep problems. The Psychiatry Society of the Chinese Medical Association ...

Claims

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Application Information

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IPC IPC(8): A61K45/00A61K36/8967A61K36/71A61K36/704A61K36/69A61K36/48A61K36/254A61K36/185A61K36/23A61K36/28A61K36/53A61K9/22A61K9/52A61P25/20A61K31/4045
Inventor 黄芳杨伟杨丽雯
Owner GUANGZHOU GONGHE MEDICINE TECH
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