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Acebrophylline sugar-free type granular formulation and preparation method thereof

An acetobromophylline, sugar-free technology, applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, respiratory system diseases, etc. Easy to take and quick absorption

Inactive Publication Date: 2009-01-28
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are not many drugs available for clinical treatment of COPD at present, and the effect is relatively single
Common therapeutic drugs include: ① anticholinergic drugs such as tiotropium bromide, etc., which block cholinergic receptors and inhibit the effect of the parasympathetic nervous system on contracting the bronchi, thereby dilating the bronchi; ②β 2 Receptor agonists such as methylxanthine, aminophylline, etc. These drugs directly stimulate airway smooth muscle β 2 ③Glucocorticoids block the inflammatory process by inhibiting the activated inflammatory gene, and are also used in the treatment of COPD, but only for the severe stage of the disease and COPD patients with repeated acute exacerbations Concerns about hormonal drugs, whose use is limited

Method used

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  • Acebrophylline sugar-free type granular formulation and preparation method thereof
  • Acebrophylline sugar-free type granular formulation and preparation method thereof
  • Acebrophylline sugar-free type granular formulation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment 1: (calculated in 1000 doses)

[0039] Acebrophylline 100g

[0040] Lactose 1710g

[0041] Stevia 150g

[0042] Orange Spice 40g

[0043] Hypromellose solution appropriate amount

[0044] The preparation method is as follows: pulverize and sieve the bromophylline, sieve lactose, stevioside, orange spice, etc., and prepare 1.5% hydroxypropyl methylcellulose and 50% ethanol solution as a wetting adhesive for standby use. Feed according to the above prescription and mix evenly, add wetting adhesive to wet, extrude through a 14-mesh sieve to prepare granules, dry at 50°C, and sieve to select dry granules with a particle size of 180 μm to 2000 μm. After testing, aluminum-plastic Encapsulate and make a sachet, that is, ready.

Embodiment 2

[0045] Embodiment 2: (calculated in 1000 doses)

[0046] Acebrophylline 150g

[0047] Lactose 2000g

[0048] Stevia 150g

[0049] Orange Spice 40g

[0050] Chlorophyll 10mg

[0051] Hypromellose solution appropriate amount

[0052] The preparation method is as follows: pulverize and sieve the bromophylline, sieve lactose, stevia, orange flavor, chlorophyll, etc., and prepare 1.5% hydroxypropyl methylcellulose and 50% ethanol solution as a wetting adhesive for standby use. Feed according to the above prescription and mix evenly, add wetting adhesive to wet, extrude through a 14-mesh sieve to prepare granules, dry at 50°C, and sieve to select dry granules with a particle size of 180 μm to 2000 μm. After testing, aluminum-plastic Encapsulate and make a sachet, that is, ready.

Embodiment 3

[0053] Embodiment 3: (calculated in 1000 doses)

[0054] Bromophylline 50g

[0055] Lactose 1370g

[0056] Stevia 100g

[0057] Banana Flavor 15ml

[0058] Chlorophyll 10mg

[0059] Hypromellose solution appropriate amount

[0060] The preparation method is as follows: pulverize and sieve the bromophylline, sieve lactose and stevioside, prepare 1.5% hydroxypropyl methylcellulose and 50% ethanol solution and mix it with banana essence as a wetting adhesive for standby use. Feed according to the above prescription and mix evenly, add wetting adhesive to wet, extrude through a 14-mesh sieve to prepare granules, dry at 50°C, and sieve to select dry granules with a particle size of 180 μm to 2000 μm. After testing, aluminum-plastic Encapsulate and make a sachet, that is, ready.

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Abstract

The invention relates to an acebromine theophylline sugar-free granular agent and a preparation method thereof, in particular to a granular agent drug which takes the acebromine theophylline as active ingredients and a preparation method thereof, belonging to the western medicine formulation field; the acebromine theophylline sugar-free granular agent consists of the following ingredients by weight in every 1000 dose: 10 to 200g of acebromine theophylline materials, 400 to 4000g of diluents, 0 to 200g of disintegrating agents, 1 to 100g of adhesives, 5 to 300g of corrigents, 0 to 100g of solid fragrances and / or 0 to 200ml of liquid fragrances and 0 to 10g of colorants. The an acebromine theophylline sugar-free granular agent of the invention has the advantages of the use of the novel corrigent and the fragrance covers the self-bitter taste of the acebromine theophylline, avoids the use of sweeteners with a large quantity of sucrose, and the like, reduces the usage of excipients greatly, leads the packing quantity of single dosage of the preparation to be reduced obviously and leads the oral administration and taking of the medicine to be more convenient; simultaneously, the conversion problem of better dosage form of the acebromine theophylline materials is solved, especially the key problem of the stability of the granular agent; the production technique of the preparation of the invention is easy to realize production on scale extremely and is suitable to the national situation in China.

Description

technical field [0001] The invention relates to acebrophylline sugar-free granules and a preparation method thereof, in particular to a granule medicine with acebrophylline as an active ingredient and a preparation method thereof, belonging to the field of western medicine preparations. Background technique [0002] "Chronic obstructive pulmonary disease" refers to chronic obstructive pulmonary disease (COPD), including chronic bronchitis, bronchial asthma and obstructive emphysema. The three basic clinical manifestations of "phlegm, cough, and wheezing" are a destructive lung disease that gradually weakens the patient's respiratory function. Many patients may suffer from persistent cough and wheezing due to unfavorable expectoration. The patients are in great pain and the quality of life is greatly affected. Long-term conditions will lead to continuous weakening of cardiopulmonary function and eventually death. It is already the main cause of death and disability worldwide...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/522A61K31/137A61P11/00
Inventor 王亚静李章才蔡桂玲王平保刘登科刘默黄长江刘颖
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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