Guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release preparation and preparation method thereof

Guaifenesin, pseudoephedrine hydrochloride and dextromethorphan hydrobromide sustained-release preparation and preparation method thereof

  • CN 101,352,440 B
  • Filed: 07/24/2007
  • Issued: 06/26/2013
  • Est. Priority Date: 07/24/2007
  • Status: Active Grant
First Claim
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1. a compound sustained-released oral drug preparation, is characterized in that, said preparation contains guaifenesin, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and slow-release auxiliary material;

  • Described slow-release auxiliary material is that consumption is hypromellose 15000 centipoises by total formulation weight amount 16% ~ 25%;

    Consumption is hypromellose 4000 centipoises by total formulation weight amount 18% ~ 28%;

    Consumption is the ethyl cellulose by total formulation weight amount 15% ~ 20%;

    Consumption is hypromellose 4000 centipoises and hypromellose 50 centipoises of 10;

    1 or 6;

    1 for the ratio by total formulation weight amount 14% ~ 22%;

    With the rate of release of this slow releasing preparation be;

    1 hour;

    the release of pseudoephedrine hydrochloride was between 20% ~ 50%;

    The release of dextromethorphan hydrobromide is between 15% ~ 40%;

    The release of guaifenesin is between 15% ~ 40%;

    3 hours;

    the release of pseudoephedrine hydrochloride was between 50% ~ 80%;

    The release of dextromethorphan hydrobromide is between 40% ~ 60%;

    The release of guaifenesin is between 40% ~ 60%;

    8 hours;

    the release of pseudoephedrine hydrochloride was greater than 80%;

    The release of dextromethorphan hydrobromide is greater than 75%;

    The release of guaifenesin is greater than 75%.2, compound sustained-released oral drug preparation as claimed in claim 1, wherein said pharmaceutical preparation also comprises other adjuvant;

    the binding agent of solid content 0.5% ~ 1.5%, consumption are wetting agent by total formulation weight amount 15% ~ 30%, the coating materials of weightening finish 2% ~ 4% for lubricant, the consumption by total formulation weight amount 0.3% ~ 1.0% for fluidizer, consumption by total formulation weight amount 0.5% ~ 2.0% for diluent, the consumption by total formulation weight amount 1.2% ~ 2.2%.3, compound sustained-released oral drug preparation as claimed in claim 2, wherein said binding agent are polyvinylpyrrolidone, hypromellose, starch slurry, syrup, dextrin, rubber cement or their mixture.4, compound sustained-released oral drug preparation as claimed in claim 2, wherein said diluent are lactose, starch, sucrose, microcrystalline Cellulose, dextrin, mannitol, sorbitol, calcium sulfate or their mixture.5, compound sustained-released oral drug preparation as claimed in claim 4, wherein said starch is pregelatinized Starch.6, compound sustained-released oral drug preparation as claimed in claim 2, wherein said lubricant are magnesium stearate, calcium stearate, Pulvis Talci, hydrogenated vegetable oil, Polyethylene Glycol, Stepanol MG, sodium lauryl sulphate or their mixture.7, compound sustained-released oral drug preparation as claimed in claim 2, wherein said fluidizer are micropowder silica gel, Pulvis Talci or their mixture.8, compound sustained-released oral drug preparation as claimed in claim 2, wherein said wetting agent are ethanol, ethanol water, water or their mixture.9, the preparation method of the described compound sustained-released oral drug preparation of any one in claim 1-8, is characterized in that, prepares with granulating respectively or isolating feeding method.

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