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Suvorexant tablet and preparation method thereof

A technology of Suwoleisheng and micro-powder, which is applied in the direction of pharmaceutical formula, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of poor dissolution performance of Suwoleisheng medicine, and achieve improvement Absorption rate and bioavailability, enhanced bioavailability, effect of increased absorption rate

Pending Publication Date: 2022-04-15
北京鑫开元医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The object of the present invention is to provide a kind of Suwo Leisheng tablet and its preparation method, to solve the problem of the poor dissolution performance of Suwo Leisheng medicine in the prior art

Method used

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  • Suvorexant tablet and preparation method thereof
  • Suvorexant tablet and preparation method thereof
  • Suvorexant tablet and preparation method thereof

Examples

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Effect test

preparation example Construction

[0032] The preparation method of the Suvoryxan solid dispersion comprises: micronizing Suvoryxan to obtain a Suvoryxan micropowder with a D90 of less than 30 μm, mixing 5-15 parts by weight of the Suvoryxan micropowder and 30-40 parts by weight Parts of copovidone were mixed uniformly, hot-melt extruded, and crushed to 60 mesh to obtain Suvorexan solid dispersion.

[0033] Wherein, the disintegrant is at least one of sodium carboxymethyl starch, croscarmellose sodium, low-substituted hydroxypropyl cellulose, and crospovidone.

[0034] The lubricant is at least one of magnesium stearate, calcium stearate, micronized silica gel and hard sodium fumarate.

[0035] The hot-melt extrusion conditions are as follows: the screw speed is 100-300rpm, the temperature is 160-180°C, and the feeding speed is 0.8-1.5kg / h.

[0036] The micropowder treatment includes: putting Suvoryson into the jet mill, the feed rate is 0.5-1.5kg / h, the crushing pressure is 0.7-0.9Mpa, and the Suvoryson micro...

Embodiment 1

[0043] A kind of Suvoret green sheet, comprises each component of following weight:

[0044]

[0045] The preparation method of the Suvorysan solid dispersion includes: putting Suvorysan into a jet mill YQ100-5, the feed rate is 1.2kg / h, the crushing pressure is 0.8Mpa, and the D90 obtained through cyclone separation is 10 μm 0.9kg of Suvoruisheng micropowder and 3.1kg of copovidone were mixed evenly, and added to the Pharma 11 hot-melt extrusion equipment. The screw speed was 200rpm, the temperature was 170°C, and the feeding speed was 1.0 Extruded under the condition of kg / h, crushed through 60 mesh to obtain Suwo Leisheng solid dispersion;

[0046] The preparation method of suwolai green tablet comprises:

[0047] Add Suvoresan solid dispersion, lactose, microcrystalline cellulose PH102, croscarmellose sodium and micropowder silica gel into the three-dimensional mixing equipment and mix for 40 minutes; the mixed materials are compressed with a rotary tablet machine to o...

Embodiment 2

[0049] A kind of Suvoret green sheet, comprises each component of following weight:

[0050]

[0051] The preparation method of the Suvorysan solid dispersion includes: putting Suvorysan into a jet mill YQ100-5, the feed rate is 1.2kg / h, the crushing pressure is 0.8Mpa, and the D90 obtained through cyclone separation is 26 μm 1.2kg of Suvoruisheng micropowder and 2.4kg of copovidone were evenly mixed, and then added to the Pharma 11 hot-melt extrusion equipment. The screw speed was 200rpm, the temperature was 160°C, and the feeding speed was 1.0 Extruded under the condition of kg / h, crushed through 60 mesh to obtain Suwo Leisheng solid dispersion;

[0052] The preparation method of suwolai green tablet comprises:

[0053] Add Suvoresan solid dispersion, lactose, microcrystalline cellulose PH102, croscarmellose sodium and micropowder silica gel into the three-dimensional mixing equipment and mix for 40 minutes; the mixed materials are compressed with a rotary tablet machine...

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Abstract

The invention relates to the technical field of medicines, and provides a suvorexant tablet and a preparation method thereof, and the suvorexant tablet comprises 35-55 parts by weight of a suvorexant solid dispersion, 10-20 parts by weight of lactose, 30-50 parts by weight of microcrystalline cellulose, 11-20 parts by weight of a disintegrating agent and 0.5-3 parts by weight of a lubricant. According to the suvorexant tablet provided by the invention, the suvorexant is subjected to micro-powder treatment, the suvorexant and the copovidone are firstly prepared into the solid dispersion by adopting a hot melting process, and then the solid dispersion and various auxiliary materials are prepared into the tablet, so that the dissolution property of the indissolvable medicine suvorexant is improved, the absorption rate of the suvorexant in a human body is favorably improved, and the curative effect of the suvorexant is improved. Therefore, the bioavailability is improved.

Description

technical field [0001] The invention relates to the technical field of medicines, and more specifically relates to a suvorai raw tablet and a preparation method thereof. Background technique [0002] Insomnia is a common condition. Patients with insomnia have difficulty falling asleep or sleeping. Prolonged sleep latency, frequent awakenings at night, prolonged awakening periods during sleep, and even brief awakenings during sleep can be regarded as symptoms of insomnia . Insomnia can cause daytime sleepiness and lack of energy; it can also cause anxiety, depression, or restlessness; people with insomnia may have difficulty concentrating, learning, and remembering. [0003] According to statistics, there are more than 300 million patients with sleep disorders in my country, and as many as 500 million people with poor sleep. Among insomniacs, 73% of them have never seen a specialist or been treated with drugs. Insomnia has become a mental illness that plagues many people, s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/28A61K31/551A61K47/32A61K47/38A61K47/26A61P25/20
CPCY02A50/30
Inventor 霍志强郭婷婷柏小娟武雪马晓凤戴信敏
Owner 北京鑫开元医药科技有限公司
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