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Robitussin oral solution composition

A technology for oral solution and medicine, which is applied in the field of expectorant medicine and its preparation, can solve the problems of being unable to cover up bitter taste and poor taste, and achieve the effects of low cost, improved stability and simple preparation process

Active Publication Date: 2014-12-24
HEBEI RENHE YIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] we discover, In addition to higher levels of related substances, the taste is also poorer
Using common flavoring agents alone, such as maltitol, sucralose, strawberry essence, cherry essence, chocolate essence, etc., cannot cover the bitter taste of guaiacol glyceryl ether and bromhexine hydrochloride compound oral liquid preparation, adding L-menthol It cannot be completely covered up, and with the increase of L-menthol, the taste of menthol becomes more and more obvious, which is not suitable for most patients
The mouthfeel and stability of Guaifenbroxin Oral Solution need to be improved and improved

Method used

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  • Robitussin oral solution composition
  • Robitussin oral solution composition
  • Robitussin oral solution composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～6

[0032] The preparation of embodiment 1~6 the new oral solution of guaiacol bromide of the present invention

[0033] prescription:

[0034]

[0035] Preparation Process:

[0036] Take bromhexine hydrochloride, add polyethylene glycol to dissolve, add purified water and stir evenly, add guaiacol and stir to dissolve, add other excipients and stir to dissolve, cool, adjust pH to 2.0-4.0 with sodium hydroxide or hydrochloric acid, add water To the full amount, filter, stir well, sub-package, that is.

experiment example 1

[0037] Experimental Example 1 Stability Research of Guaifenol Broxin Oral Solution of the present invention

[0038] Utilize the Guaifenol bromide oral solution and the commercially available preparation that embodiment 1~4 makes ( ) for long-term stability test (25°C, RH60%), the detection method of related substances (%) is as follows: take an appropriate amount of this product, dilute with water to make a solution containing 4mg per 1ml (calculated as guaiacol glyceryl ether) , as the test solution; accurately measure the appropriate amount of the test solution, dilute it with water to make a solution containing 20 μg of guaiacol glyceryl ether per 1 ml, as a control solution. Measure according to high-performance liquid chromatography (Chinese Pharmacopoeia 2010 edition two appendix Ⅴ D), use octadecylsilane bonded silica gel as filler (XBP C184.6 * 150mm); With 0.1% glacial acetic acid solution (adjust pH with ammonia water) to 5.0) as mobile phase A, and acetonitrile a...

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Abstract

The invention provides a robitussin oral solution and a preparation method thereof. The robitussin oral solution comprises guaiacol glycerol ether, bromhexine hydrochloride, coolsense and polyethylene glycol. The robitussin oral solution provided by the invention has the characteristics of simple preparation technology, good taste, high quality and good stability.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to an expectorant and a preparation method thereof. Background technique [0002] Guaifenesin, namely 3-(2-methoxyphenoxy)-1,2-propanediol, is a powerful expectorant, which can increase the secretion of respiratory glands, dilute sputum, and easily cough up. [0003] Bromhexine Hydrochloride (BRH), that is, N-methyl-N-cyclohexyl-2-amino-3,5-dibromobenzylamine hydrochloride, which directly acts on bronchial glands and can make mucus The lysosomes of secretory cells are released to depolymerize the mucopolysaccharides in the mucus, reduce the viscosity of the mucus, and also cause the respiratory tract to secrete low-viscosity small molecule mucins, making the sputum thinner and easier to cough up. [0004] The mechanism of action of guaiacol and bromhexine hydrochloride is different, and its compound preparation, guaiacol bromhexine oral solution, has a better expectorant effect d...

Claims

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Application Information

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IPC IPC(8): A61K31/137A61K9/08A61K47/10A61P11/10
Inventor 牛菁菁
Owner HEBEI RENHE YIKANG PHARMA
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