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Bambuterol hydrochloride and roflumilast compound preparation and its preparation method

A technology of bambuterol hydrochloride and roflumilast, which is applied in the direction of pill delivery, active ingredients of esters, active ingredients of heterocyclic compounds, etc., can solve problems such as inapplicability, and achieve convenience in taking, good taste, and simple preparation process Effect

Inactive Publication Date: 2014-06-04
岳阳新华达制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because this drug is different from other drugs for the treatment of severe COPD with chronic bronchitis, it is indicated for the treatment of patients with severe COPD with chronic bronchitis and exacerbations to reduce the risk of COPD exacerbations. This drug is not a bronchodilator , and not suitable for the relief of acute bronchiectasis

Method used

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  • Bambuterol hydrochloride and roflumilast compound preparation and its preparation method
  • Bambuterol hydrochloride and roflumilast compound preparation and its preparation method
  • Bambuterol hydrochloride and roflumilast compound preparation and its preparation method

Examples

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Effect test

example 1

[0030] Babuterol hydrochloride fast-release layer and roflumilast slow-release layer compound double-layer tablet, including main drug and auxiliary materials, is characterized in that it is formulated according to the following weight percentage: main drug: 2.625%, auxiliary materials: 97.375% .

[0031] Immediate-release tablet formulation:

[0032]

[0033] Extended-release tablet formulation:

[0034]

[0035]

[0036] Among them, corn starch, lactose, and microcrystalline cellulose are fillers; hydroxypropyl methylcellulose k4M and hydroxypropyl methylcellulose k15M are binders; cross-linked polyvinylpyrrolidone is a disintegrant; gelatin, talc The powder is effervescent; distilled water and magnesium stearate are lubricants.

[0037] The preparation method of the compound double-layer tablet of bambuterol hydrochloride quick-release layer and roflumilast slow-release layer of the present invention comprises raw material crushing, weighing, mixing uniformly, an...

example 2

[0042] Babuterol hydrochloride fast-release layer and roflumilast sustained-release layer compound double-layer tablet, including main drug and auxiliary materials, is characterized in that it is formulated according to the following weight percentages: main drug: 5.25%, auxiliary materials: 94.75% .

[0043] Immediate-release tablet formulation:

[0044]

[0045]

[0046] Extended-release tablet formulation:

[0047]

[0048] Among them, corn starch, lactose, and microcrystalline cellulose are fillers; hydroxypropyl methylcellulose k4M and hydroxypropyl methylcellulose k15M are binders; cross-linked polyvinylpyrrolidone is a disintegrant; gelatin, talc The powder is effervescent; distilled water and magnesium stearate are lubricants.

[0049] The preparation method of the compound double-layer tablet of bambuterol hydrochloride quick-release layer and roflumilast slow-release layer of the present invention comprises raw material crushing, weighing, mixing uniformly, ...

Embodiment 3

[0054] The compound syrup of bambuterol hydrochloride and roflumilast comprises main ingredients and auxiliary materials, and is characterized in that it is formulated according to the following weight percentages: main ingredients: 0.0512%, auxiliary materials: 99.9488%. Compound syrup of the present invention is formulated from the raw materials of following weight ratio:

[0055]

[0056] Among them, liquid glucose and sucrose are sweet additives; vitamin C is an antioxidant; sodium metabisulfite is a preservative; edetate disodium is a complexing agent; purified water is a diluent.

[0057] The preparation method of bambuterol hydrochloride and roflumilast compound syrup of the present invention comprises the steps of pulverizing raw materials, weighing, mixing, stirring, filtering and sterilizing, and is characterized in that the specific process steps are as follows:

[0058] Step 1: Pulverize bambuterol hydrochloride, roflumilast and the above-mentioned various excip...

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Abstract

The invention discloses a bambuterol hydrochloride and roflumilast compound preparation comprising a bambuterol hydrochloride and roflumilast slow-release layer compound double-layer tablet and a compound syrup agent. The main drug comprises bambuterol hydrochloride and roflumilast, accessories include corn starch, lactose, microcrystalline cellulose, hydroxypropyl methyl cellulose k4M, hydroxypropyl methyl cellulose k15M, cross-linked polyvinylpyrrolidone, gelatin, talcum powder, distilled water, magnesium stearate, liquid glucose, sucrose, vitamin C, sodium pyrosulfite, edetate disodium, an orange juice flavoring agent, an edible color matching agent and purified water. The bambuterol hydrochloride and roflumilast compound preparation has a good synergistic therapeutic effect on patients subjected to severe chronic obstructive pulmonary disease (COPD) along with chronic bronchitis, can simplify the treatment, and can improve the patient compliance.

Description

Technical field: [0001] The invention relates to an oral drug compound preparation for treating chronic obstructive pulmonary disease (COPD) and a preparation method thereof, in particular to a compound preparation of two main drug formulations and a preparation method thereof. Background technique [0002] Bambuterol hydrochloride is a long-acting beta 2 receptor agonist. The drug is a new generation of bronchodilator developed by Swiss company Astra in 1989. It is used for the treatment of bronchial asthma and is one of the main drugs for the treatment of asthma, emphysema and bronchitis. Babuterol is a dicarbamate prodrug of terbutaline, with strong lipophilicity, it can be preferentially distributed in the lung tissue after oral administration, reducing the first-dose effect, and can be slowly hydrolyzed in the lung tissue to produce terbutaline , so as to produce a stable and continuous terbutaline concentration in the blood, the effect can reach 24 hours, take once a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/44A61K31/27A61K9/20A61K9/10A61P11/00
Inventor 郭凌云刘群奇张长利焦佩玉
Owner 岳阳新华达制药有限公司
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