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Dosage form and preparation method of acebrophylline oral solution

A technology of bromophylline and oral solution, which is applied to medical preparations containing active ingredients, pharmaceutical formulas, respiratory diseases, etc., can solve problems such as technical reports of bromophylline solution-type preparations, and improve bioavailability , Improve compliance, and take convenience

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

In the existing professional literature, there is no report on the preparation technology of bromophylline solution

Method used

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  • Dosage form and preparation method of acebrophylline oral solution
  • Dosage form and preparation method of acebrophylline oral solution
  • Dosage form and preparation method of acebrophylline oral solution

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-12

[0033] Embodiment 1-12: Preparation of bromophylline oral solution

[0034] 1. Prescription: Use deionized water as solvent to make a solution with a total volume of 1000ml.

[0035] Table 1: Formulations of Examples 1-12

[0036] Example

Vinegar bromide tea

Alkali (g)

glycerin and / or propylene glycol

Alcohol (ml)

pH regulator

(appropriate amount)

flavoring agent

(g)

antibacterial agent

(g)

1

20

Glycerin 200

citric acid

Sucrose 300

Peppermint essence amount

Orange flavor appropriate amount

Ethylparaben 0.5

[0037] 2

10

Propylene Glycol 300

citric acid

Sucrose 200

Appropriate amount of strawberry essence

Methylparaben 0.5

3

5

Glycerin 100

Propylene Glycol 100

citric acid

Sucrose 150

Peppermint essence amount

Orange flav...

Embodiment 13

[0041] Example 13. pH value optimization experiment

[0042] In order to optimize the range of pH in the process, the oral solutions of Example 1 with different pH were subjected to accelerated experiments, stored in a constant temperature and humidity chamber at 40°C / RH75%, and stored for one month, and samples were taken on 5, 10, 20, and 30 days one check.

[0043] Inspection items: appearance, taste, content, degradation products. The experimental results are shown in Table 2.

[0044] Table 2: pH range optimization results of bromophylline oral solution

[0045]

[0046]

[0047] All samples in the above tests were packaged the same, so the difference in stability should be caused by the difference in pH value. The results showed that an appropriate pH value is not only beneficial to the stability of the oral solution of bromophylline, but also can improve the inherent unpleasant bitterness of the bromophylline. The process of the present invention emphasizes th...

Embodiment 14

[0048] Example 14. Package inspection

[0049] Get the preparation that pH value is 4.0 with embodiment 1, adopt transparent bottle packing, put 4000Lx-5000Lx light under the accelerated experiment, in 5, 10 days each sampling once inspection.

[0050]Inspection items: appearance, taste, content, degradation products. The experimental results are shown in Table 3.

[0051] Table 3: Accelerated light test results of acebrophylline oral solution

[0052]

[0053] Above-mentioned experimental result shows: the acebrophylline oral solution prepared by the inventive method should adopt light-proof packaging during preservation.

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Abstract

The invention discloses a formulation of oral solution of acebromine theophylline and a preparation and belongs to the western medicine formulation field; the oral solution of acebromine theophylline has pH value of 3.0 to 6.5 and consists of the following ingredients with percentage: 0.1 to 2 percent (W / V) of acebromine theophylline, 0 to 30 percent (V / V) of glycerin and / or propylene glycol, moderate pH regulator, 0.001 to 50 percent of corrigent, 0.002 to 0.5 percent of bacteriostat and the solvent is water. The invention has the advantages that: the oral solution of acebromine theophylline of the invention has stable quality, the drug is dispersed in the medium in molecular state with large dispersity and fast absorption, the drug effect can be played and the bioavailability is improved; the oral solution of acebromine theophylline of the invention has convenient taking, easy dosage division, sour and sweet and smooth taste and fragrant smell and can improve patient compliance.

Description

technical field [0001] The invention relates to a dosage form and a preparation method of acebrophylline oral solution, belonging to the field of western medicine preparations. Background technique [0002] Acebromophylline is a derivative of theophylline, which has superior expectorant and anti-asthma effects, can increase bronchial ciliary movement, stimulate bronchial mucus secretion, enhance mucus transport, reduce airway resistance, and promote sputum discharge, thereby significantly reducing asthma. Patients with chronic airflow obstruction, shortness of breath, cough, sputum, asthma and other symptoms can delay the progress of the disease and greatly improve the patient's quality of life. Based on its non-unitary drug effect, it is widely used in the treatment of diseases such as bronchial asthma, bronchitis, pharyngitis, and sinusitis. Compared with similar drugs currently used, the drug has good curative effect, low incidence of side effects, and is safe. Sexuality...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/522A61K31/137A61P11/00
Inventor 王亚静蔡桂玲蒋庆峰金松子李章才王平保刘登科刘默黄长江刘颖
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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