Oral liquid for treating respiratory disease and preparation method thereof

A technology of oral liquid and respiratory tract, which is applied in the field of oral liquid for the treatment of respiratory diseases and its preparation, which can solve the problems of affecting bilirubin binding and danger, achieve the effect of inhibiting microbial growth and improving physical and chemical stability

Active Publication Date: 2011-02-02
武汉人福药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Parabens have been reported to cause delayed contact dermatitis and their use in injectable formulations for infants can interfere with bilirubin conjugation, potentially dangerous especially in patients with hyperbilirubinemia

Method used

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  • Oral liquid for treating respiratory disease and preparation method thereof
  • Oral liquid for treating respiratory disease and preparation method thereof
  • Oral liquid for treating respiratory disease and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0032] (1) Preparation of oral liquid

[0033] The oral liquid for treating respiratory diseases of the present invention uses xylitol instead of preservatives, and is used in the oral liquid whose active ingredient is ambroxol hydrochloride, or ambroxol hydrochloride and clenbuterol hydrochloride. The preservatives refer to benzoic acid or its salts, butylated hydroxytoluene, tert-butylhydroxyanisole, ethylenediaminetetraacetic acid, peroxybenzoate, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, p-hydroxybenzoate Propyl hydroxybenzoate, butyl p-hydroxybenzoate, chlorhexidine acetate, benzyl alcohol, anhydrous acetic acid, sorbic acids, benzalkonium chloride, phenol, chlorobutanol or thimerosal, etc. are known by those skilled in the art Substances used in oral fluids to inhibit the growth of microorganisms are well known.

[0034] The oral liquid may contain other excipients commonly used in oral liquid formulations in order to provide the required stability and therapeu...

Embodiment 1-3

[0041] Components of the oral solution:

[0042]

Example 1

Example 2

Example 3

Ambroxol hydrochloride / g

0.1

0.15

0.15

Clenbuterol hydrochloride / g

0.0001

0.0001

0.0001

Xylitol / g

25

30

35

Grape essence / g

0.1

0.1

0.1

Citric acid / g

0.2

----

----

Vitamin C / g

0.1

----

0.1

Sodium citrate / g

0.1

----

----

[0043] water

100ml

100ml

100ml

[0044] Preparation Process:

[0045] First add the amount of xylitol into 50ml of water, heat slightly, stir, after the xylitol is completely dissolved, add ambroxol hydrochloride and clenbuterol hydrochloride successively, add essence, citric acid, One or more combinations of sodium citrate and vitamin C, add water to 100ml, stir evenly, and get ready.

Embodiment 4-6

[0047] Composition of oral liquid:

[0048]

Example 4

Example 5

Example 6

Ambroxol hydrochloride / g

0.6

0.3

0.8

Xylitol / g

25

30

35

Sorbitol / g

10

10

10

Strawberry essence / g

0.1

0.1

0.1

Citric acid / g

0.2

0.2

----

Sodium metabisulfite / g

0.1

----

0.1

Sodium citrate / g

0.1

0.1

----

water

100ml

100ml

100ml

[0049] Preparation Process:

[0050]First add the amount of xylitol and sorbitol into 50ml water, heat slightly, stir, after xylitol and sorbitol are completely dissolved, add ambroxol hydrochloride, stir and dissolve, add essence, citric acid, citric acid Sodium, sodium metabisulfite, or a combination of two or more, add water to 100ml, stir well, and get ready.

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Abstract

The invention discloses an oral liquid for treating a respiratory disease. The oral liquid is aqueous solution, does not comprise a preservative but comprises the following components: 1-8g / L ambroxol hydrochloride and 250 to 350 g / L xylitol. A preparation method for the oral liquid comprises the following steps of: 1) adding the xylitol in the amount into water, and stirring until dissolving completely; 2) adding the ambroxol hydrochloride, or adding the ambroxol hydrochloride and clenbuterol hydrochloride into the solution obtained in the step 1) in turn, and stirring until dissolving; and 3) adding a pH regulator into the solution obtained in the step 2), regulating the pH of the oral liquid to be between 4.0 and 6.0; adding one or a combination of a sweetening agent, an antioxidant and an aromatizer; and stirring uniformly to obtain the oral liquid. The oral liquid obtained by the preparation method does not comprise the preservative but has adequate chemical stability and microbial stability, avoids a series of toxic and harmful effects caused by using the preservative, and ensures the safety of medication.

Description

technical field [0001] The invention relates to an oral liquid for treating respiratory diseases and a preparation method thereof. Background technique [0002] Oral liquid preparations, especially liquid preparations that use water as a solvent, are difficult to completely avoid microbial contamination during the preparation process, and they are easily contaminated by microorganisms and become moldy and deteriorated, especially oral liquid preparations containing nutrients such as sugars and proteins. It is easy to cause the growth and reproduction of microorganisms. Liquid formulations of antimicrobials can also grow microorganisms. Liquid preparations contaminated by microorganisms will cause changes in physical and chemical properties, seriously affect the quality of preparations, and sometimes produce bacterial toxins that are harmful to human health. Therefore, for the aqueous liquid preparation to prevent its mildew, it is necessary to add preservatives to maintain...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/10A61K31/137A61P11/00A61K9/00
Inventor 务睿漆进军刘红华张传涛张桃萍卢山郭芬
Owner 武汉人福药业有限责任公司
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