METHOD FOR PREPARING A STABLE PHARMACEUTICAL COMPOSITION WITH FIXED DOSING FROM ANTIINFECTIVE AGENT / AGENTS AND MICROORGANISMS AS ACTIVE INGREDIENTS

摘要

Microorganisms are useful in the treatment of diseases, including diarrhea and gastrointestinal diseases, such as pseudomembranous colitis, megacolon, etc. They are also useful in preventing gastrointestinal disorders and diseases caused by anti-infective agents such as ampicillin, amoxicillin, cloxacillin, clauvanovic acid, cefuroxime axetil, cephalexin, erythromycin, etc. To prevent micro-organisms, they should be taken with anti-infective agents. Microorganisms are combined with anti-infective agents to simplify administration and improve compliance and therapeutic effect, the combination is not stable at room temperature, since microorganisms are sensitive to anti-infective agents and in such a composition are destroyed by the action of anti-infective agent. The present invention relates to a method for preparing a stable formulation with a fixed dosage from an anti-infective agent and microorganisms as active ingredients. The method involves the preparation of various dosage forms for oral administration, such as capsules, tablets and a liquid formulation. The method comprises providing a suitable barrier by selectively coating one of the active ingredients so that microorganisms are not exposed to anti-infective agents. The result is a stable composition. Using a suitable coating technology, the composition remains stable for 3-36 months at room temperature. The ratio of microorganisms to anti-infective agents in the composition can be from 1: 2 to 1:25 by weight. Weight