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Dry suspension containing Arbidol and salt thereof as well as preparation method of dry suspension

A technology of arbidol hydrochloride and suspension, which is applied in the direction of antiviral agent and powder delivery, etc. It can solve the problems of arbidol raw material not being resistant to high temperature, failing to achieve drug curative effect, delaying drug release, etc., to achieve effective Conducive to industrialization and product quality control, improve bioavailability, and avoid exposure to high temperatures

Inactive Publication Date: 2016-01-20
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] CN102000030A discloses a dry suspension of Arbidol used in the medical and health industry and its preparation method. After the invention adopts a wet granulation process to make the dry suspension of Arbidol, it effectively covers the The bitter taste of Abidol greatly improves the patient's compliance, but the raw material of Abidol is not resistant to high temperature, so the wet granulation and drying process has risks to the quality of the variety
[0007] CN101904826A discloses an orally disintegrating tablet of arbidol hydrochloride and its preparation method. The invention has simple process control, fast absorption, high bioavailability, and is convenient to take. However, the process adopts the process of granulation and coating. It is cumbersome, the production parameters are not easy to control, and it is not conducive to industrialization
However, the sustained-release tablet releases the drug slowly, and cannot release the active ingredient of the drug quickly, so that the maximum blood drug concentration is low.
[0015] CN100367957C discloses a preparation for intravenous administration of arbidol and its salt and its preparation method. This method improves the bioavailability of the drug, but the salt formation process of this technology is complicated, and there is no arbidol that meets the national standard in China. Salt raw material, not conducive to industrialization
[0016] CN101066248 discloses a kind of Arbidol granules and preparation method thereof, the method adopts granule coating technology, although the bitter feeling brought by raw materials is improved, but adopts polymer coating technology, delays the release of medicine, reduces the The bioavailability of the drug cannot reach the expected drug effect
[0017] CN101249076 discloses a kind of Arbidol granule preparation and its fluidized bed coating preparation method, the method uses a fluidized bed to coat the granule intermediate, but uses a fluidized bed to coat the granules. The dry mixing process of Dole and its salt dry suspension is more cumbersome and complicated, and the parameters are difficult to control, which is not conducive to the industrialization of this variety

Method used

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  • Dry suspension containing Arbidol and salt thereof as well as preparation method of dry suspension
  • Dry suspension containing Arbidol and salt thereof as well as preparation method of dry suspension
  • Dry suspension containing Arbidol and salt thereof as well as preparation method of dry suspension

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A kind of Arbidol and its salt dry suspension, take Arbidol hydrochloride 200g, hypromellose 40g, sucralose 2g, mannitol 200g, sucrose 1540g and peach essence 10g, 0.03% cochineal Appropriate amount of red pigment aqueous solution; control the particle size of Arbidol hydrochloride D90: 1-20 μm, crush sucralose and peach flavor through a 100-mesh sieve; crush sucrose and mannitol through a 80-mesh sieve; hypromellose through a 100-mesh sieve Sieve; fully mix sucrose and mannitol, add an appropriate amount of 0.03% cochineal pigment aqueous solution, make soft material, granulate with a 32 mesh sieve, dry at 50°C for 60 minutes, pass through a 28 mesh sieve for granulation, add arbidol hydrochloride, three Sucralose, hypromellose, and peach flavor are mixed evenly, and after passing the inspection, they are put into composite film bags to make 1000 bags of 2g each or 2000 bags of 1g each.

Embodiment 2

[0027]A kind of Arbidol and its salt dry suspension, get Arbidol hydrochloride 200g, Arabic gum 20g, hydroxypropyl cellulose 20g, mannitol 180g, aspartame 2.0g, sucrose 1560g and peach flavor 10g, appropriate amount of 0.03% lemon yellow pigment aqueous solution; Arbidol hydrochloride controlled particle size D90: 1-20 μm, sucrose, mannitol, crushed to 80 mesh; gum arabic, hydroxypropyl cellulose, aspartame, peach The essence is crushed separately and passed through a 100-mesh sieve; the sucrose and mannitol are fully mixed, and an appropriate amount of 0.03% lemon yellow pigment aqueous solution is added to make a soft material, granulated with a 32-mesh sieve, dried at 50°C for 90 minutes, passed through a 28-mesh sieve for granulation, and added with hydrochloric acid Bidol, aspartame, gum arabic, and peach essence are mixed evenly, and after passing the inspection, put them into a composite film bag to make 1000 bags of 2g each or 2000 bags of 1g each.

Embodiment 3

[0029] A kind of Arbidol and its salt dry suspension, get Arbidol hydrochloride 100g, hydroxypropyl cellulose 90g, xanthan gum 30g, sucrose 400g, mannitol 350g, aspartame 2.5g, lemon essence 10g, an appropriate amount of 0.03% lemon yellow pigment aqueous solution; Arbidol hydrochloride controlled particle size D90: 1 ~ 20μm, sucrose, mannitol crushed through 80 mesh; hydroxypropyl cellulose, xanthan gum, aspartame and lemon The essence is crushed separately and passed through a 100-mesh sieve; the sucrose and mannitol are fully mixed, and an appropriate amount of 0.03% lemon yellow pigment aqueous solution is added to make a soft material, granulated with a 32-mesh sieve, dried at 50°C for 100 minutes, passed through a 20-mesh sieve for granulation, and added with hydrochloric acid. Bidol, xanthan gum, hydroxypropyl cellulose, aspartame and lemon essence are mixed evenly. After passing the inspection, put them into a composite film bag to make 1000 bags, 2g per bag or 2000 bag...

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Abstract

The invention discloses a dry suspension containing Arbidol and a salt thereof as well as a preparation method of the dry suspension. The dry suspension comprises arbidol hydrochloride, a suspending aid, a filling agent, a corrigent and edible pigment, wherein the suspending aid is one or several Arabic gum, tragacanth, sodium alginate, povidone, hydroxypropyl cellulose, xanthan gum and hydroxypropyl methylcellulose; the filling agent is one or several of saccharose, mannitol and microcrystal cellulose; the corrigent comprises a sweetening agent and a flavoring agent, wherein the sweetening agent is one or several of mannitol, saccharose, cyclamate, aspartame and sucralose; the flavoring agent is one or several of a juicy peach essence, a banana essence, a lemon essence, a strawberry essence and an apple essence; and the edible pigment is one or several of lemon yellow, sunset yellow and a cochineal dye. After the Arbidol and the salt thereof are prepared into the dry suspension, the bitter tastes of Arbidol and the salt thereof are effectively covered, and the patient taking compliance is greatly improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical packaging, in particular to arbidol and its salt dry suspension and a preparation method thereof. Background technique [0002] Arbidol is a highly effective drug for preventing and treating type A and type B influenza and other acute respiratory virus infections. The mechanism of action is different from commonly used clinical antiviral drugs such as ribavirin, amantadine and rimantadine; it induces interferon and enhances immune function to fight against influenza virus; All of them have antagonism effect, and have a wider antiviral spectrum than amantadines, and also have the effect of activating macrophages, and can effectively treat influenza and other acute respiratory virus infections. Recent studies have shown that the drug also has a better inhibitory effect on atypical viruses at a lower safe concentration. Arbidol hydrochloride has very low toxicity. Foreign literature reports that rats ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/4045A61K47/26A61K47/38A61K47/36A61P31/16A61P31/14
Inventor 曲继广杨帆李彪张洪昌贾萧铭杨俊免
Owner SHIJIAZHUANG NO 4 PHARMA
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