Pharmaceutical composition for treating cold in children and preparation method thereof

Abstract

The invention provides a pharmaceutical composition for treating cold in children and a preparation method thereof. The pharmaceutical composition comprises the following components and medicine prepared in ratio: dextromethorphan hydrobromide, chlorphenamine maleate, ammonium chloride, seasoning agent, antiseptic and water, wherein the dextromethorphan hydrobromide is coated by beta-cyclodextrin and is prepared into preparation; the clathrate compound improves the mouthfeel and the water solubility of the dextromethorphan, and realizes delayed release effect so that, after being administrated, the dextromethorphan continuously develops functions of relieving cough in 2-6h, and the ammonium chloride is rapidly released for dispelling phlegm within 1h, thereby effectively solving the problem of antagonism between the dextromethorphan and the ammonium chloride. The pharmaceutical composition can be prepared into syrup, oral solution and drop which are easily accepted by the children. The pharmaceutical composition is simple in preparation technique, easy in production and operation, good in producing stability, reliable in product quality, sweet in taste, good in compliance, and acceptable by children; the dose is accurately measured according to age of the children; and the pharmaceutical composition can safely and rapidly eliminate or relieve cold symptoms of the children, such as cough, excessive and thick phlegm, pharyngalgia, rhinobyon, rhinorrhoea, sternutation and the like caused by infection of upper respiratory tract and allergic reaction.

Description

technical field [0001] The invention relates to a pharmaceutical composition for infantile colds and a preparation method thereof for syrup, oral solution and drops. Background technique [0002] Common colds are common in all seasons, especially in winter and spring, and infants and young children have low immune function, and the disease is more common. The onset can be acute or slow. Most of them have symptoms of upper respiratory tract infection first, dry cough at first, and then gradually worsen, accompanied by increased respiratory secretions. If secondary bacterial infection occurs, the sputum will change from mucus to pus after a few days. Infants and young children are not easy to cough up sputum, and it often stays in the throat and makes a rolling sound or the sputum is swallowed into the digestive tract. Other symptoms include nasal congestion, runny nose and sneezing, fever, fatigue, loss of appetite and vomiting. If cough and expectoration do not heal for a ...

AI Technical Summary

Problems solved by technology

From the analysis of the physiological response of antitussive and expectorant, it can inhibit the discharge of sputum while suppressing cough, and cause cough while eliminating phlegm. Solve the mutual antagonism of the two effects, so the curative effect is not precise enough

[0005] Hong Kong Lexin Pharmaceutical Co., Ltd.'s baby cough water, the formula is: dextromethorphan hydrobromide + chlorpheniramine maleate + ammonium chloride, it was imported to the domestic market in 2003, and the product name is compound safenam Min syrup, but because it has not solved the mutual antagonism between antitussive and expectorant in the above analysis through advanced technology, the curative effect is not satisfactory. At the same time, because dextromethorphan is not water-soluble and has a bitter and numb taste, it has a bad taste. In 2008, 1 It failed to re-register after the expiration of its registration certificate, so there is no compatible preparation of dextromethorphan + chlorpheniramine + ammonium chloride in the domestic market; there is no dextromethorphan + chlorpheniramine + ammonium chloride Bibliographical reports on pediatric formulations

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