Spongy dextromethorphan hydrobromide film agent with micro-pore and preparation method thereof

Abstract

The invention discloses a spongy dextromethorphan hydrobromide film agent with micro-pore and a preparation method of the film agent; the spongy dextromethorphan hydrobromide film agent with micro-pore comprises the following components: a dextromethorphan hydrobromide, a water-soluble polymer material, and a water-insoluble micro-powder dispersed in the water-soluble polymer material; the water-soluble polymer material is any two of HPMC (hydroxy propyl methyl cellulose), PVA (polyvinyl alcohol), HPC (hydroxy propyl cellulose), CMC-NA (sodium carboxyl methyl cellulose), PVP (polyvinyl pyrrolidone), sodium alginate or PEO (polyethylene oxide), and wherein one is a lower molecular weight water-soluble polymer material with molecular weight of 10, 000-200, 000 Dalton, the other one is a higher molecular weight water-soluble polymer material with molecular weight of 200, 000-10, 000, 000 Dalton. According to the invention, effects are very significant; films are dissolved fast through the lower molecular weight water-soluble polymer material, physical strength and toughness of films are ensured through the higher molecular weight water-soluble polymer material so as to realize the purpose of quick release and ensure strength of films.

Description

technical field [0001] The invention relates to a dextromethorphan hydrobromide preparation. Background technique [0002] Coughing is a defensive reflex activity produced when the respiratory system is stimulated. Mild cough is good for expectoration, generally do not need to use antitussives, but severe cough, especially dry cough with no phlegm will affect rest and sleep, or cause other complications, you need to use antitussives. [0003] Dextromethorphan (Dextromethorphan) is a morphine-type central nervous antitussive drug, and its hydrobromide salt is used clinically. It was developed and listed by Roche in 1954 and registered in my country in 1988. So far, a variety of dosage forms such as tablets, capsules, granules, dry suspensions, and syrups have been approved for production, imported or entered the clinical stage of new drugs. [0004] Children and the elderly have weak body resistance and are prone to colds, coughs and other diseases. The taste of dextromet...

AI Technical Summary

Problems solved by technology

Not conducive to production, transportation, storage and use

The usual practice is to add a sufficient amount of plasticizer, but while increasing the proportion of plasticizer, the proportion of polymer materials is relatively reduced, which is not conducive to the formation of the film

In order to ensure the strength of the membrane when the proportion of polymer is small, it is necessary to use materials with higher molecular weight and higher viscosity, so that the dissolution of the membrane will be slowed down, and the effect of rapid onset of action will not be achieved.

[0010] And when adopting the technology disclosed by the inventor's prior patent application to prepare dextromethorphan hydrobromide film, the test found that there was also the defect that the film was brittle and fragile in the process of cutting and packaging, which needed to be improved.

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