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A kind of ambroxol hydrochloride sustained-release dry suspension and preparation method thereof

A technology of ambroxol hydrochloride and dry suspension, which is applied in the field of ambroxol hydrochloride slow-release dry suspension and its preparation, can solve the problems of low frequency of bioavailability, poor drug compliance, etc., and solve the pain of taking medicine , blood drug concentration is stable, and the effect of improving compliance

Active Publication Date: 2011-12-07
佛山市隆信医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to overcome the shortcoming and deficiency of prior art, provide a kind of ambroxol hydrochloride sustained-release dry suspension, long-lasting effect, high bioavailability, less times of taking medicine, can solve the problem of taking medicine for old people, children and patients with dysphagia The problem of poor compliance

Method used

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  • A kind of ambroxol hydrochloride sustained-release dry suspension and preparation method thereof
  • A kind of ambroxol hydrochloride sustained-release dry suspension and preparation method thereof
  • A kind of ambroxol hydrochloride sustained-release dry suspension and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0030] 1. Preparation of drug-loaded pellet core

[0031] The proportioning of each component of drug-loaded pellet core is as follows:

[0032]

[0033] In other embodiments, the ratio of broxol hydrochloride, starch, and microcrystalline cellulose can also be: broxol hydrochloride 20g, starch 80g, microcrystalline cellulose 100g; or broxol hydrochloride 50g, starch 50g, microcrystalline cellulose 100g.

[0034] making process:

[0035] Ambroxol hydrochloride, starch, and microcrystalline cellulose are mixed uniformly by an equal increase method, and the aqueous solution is used as a binder to make a soft material, and the extrusion-spheronization mechanism pellets are adopted, and the particle size of the sieve plate is 0.2mm, and then Dried in an oven at 50°C, sieved, and selected pellets smaller than 80 mesh for the next step of coating process.

[0036] 2. Packed with slow-release coating

[0037]

[0038] Coating process: Add the prescribed amount of Surelease ...

Embodiment 2

[0044] 1. Preparation of drug-loaded pellet core

[0045] The proportioning of each component in the drug-loaded pellet core is as follows:

[0046]

[0047] Note: The above percentages are percentages by weight.

[0048] The preparation process of drug-loaded pellet core is as follows:

[0049] Mix ambroxol hydrochloride, lactose, and microcrystalline cellulose evenly by increasing the amount in equal amounts, put them into a multifunctional fluidized bed, and make pellets by centrifugal method. The liquid speed is properly adjusted depending on the degree of dryness and wetness of the drug powder, so that the drug powder gradually forms fine pellets under the action of centrifugal force and binder, dried in an oven at 50°C, and sieved to select pellets smaller than 80 mesh. Perform coating.

[0050] The process parameters set above are: the speed of the turntable is 300r / min, the air intake volume can be set in the range of 20HZ~30HZ, in this embodiment it is 27HZ, in ...

Embodiment 3

[0060] 1. Preparation of drug-loaded pellet core

[0061]

[0062] making process:

[0063] Ambroxol hydrochloride, lactose, and microcrystalline cellulose are mixed uniformly by an equal increase method, and an aqueous solution is used as a binder to make a soft material, and extrusion-spheronization mechanism pellets are used, and the particle size of the sieve plate is 0.2mm. Dried in an oven at 50°C, sieved, and selected pellets smaller than 80 mesh for coating.

[0064] 2. Packed with slow-release coating

[0065]

[0066] Add the prescribed amount of talc powder into water and stir for 30 minutes, add triethyl citrate, Eudragit RS30D, RL30D water dispersion to make it fully dispersed, continue stirring for 30 minutes to form a slow-release coating solution, and set aside. The drug-loaded pellet core was placed in a fluidized bed, and various process parameters were set. During the experiment, the parameters were constantly adjusted to ensure the state of fluidiza...

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Abstract

The invention discloses an ambroxol hydrochloride sustained-release dry suspension, which is prepared from the following components in percentage by weight: 20 to 60 percent of sustained-release micro-pills, 39.9 to 79.5 percent of suspending aid and 0.1 to 0.5 percent of flavoring agent, wherein the sustained-release micro-pills are prepared by wrapping a sustained-release coating layer outside medicine-carrying pill cores, and the medicine-carrying pill cores comprise 10 to 30 weight percent of ambroxol hydrochloride and 70 to 90 weight percent of pharmaceutic adjuvant. The ambroxol hydrochloride sustained-release dry suspension can be released continuously for 24 hours, can be taken by adding proper amount of warm water, is particularly suitable for treating phlegm eliminating treatment of acute and chronic respiratory tract diseases in olds, children and people who have difficulty in swallowing, and can increase the compliance of administration of patients. The invention also discloses a preparation method for the ambroxol hydrochloride sustained-release dry suspension.

Description

technical field [0001] The invention relates to the technical field of preparations of ambroxol hydrochloride, in particular to a sustained-release dry suspension of ambroxol hydrochloride and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride (Ambroxol hydrochloride), also known as bromcycline hydrochloride, is a new mucolytic drug that can promote the emptying of bronchial cilia and facilitate the discharge of airway secretions. Clinically, it is mainly used for the expectorant treatment of acute and chronic respiratory diseases, especially chronic bronchitis. Its expectorant effect is strong, and it is one of the widely used expectorant medicines at home and abroad. In addition to its powerful mucolytic effect, ambroxol hydrochloride is characterized by its ability to stimulate alveolar type II cells and promote the synthesis and secretion of alveolar surfactant, thereby effectively enhancing mucus transport and promoting expectoration. I...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/32A61K47/34A61K47/36A61K47/38A61K31/137A61P11/10
Inventor 陈华兆黎炜烘黎秉富曲金栋
Owner 佛山市隆信医药科技有限公司
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