摘要 |
PURPOSE:A sustained release granular material, obtained by applying talc to a granular material of procainamide hydrochloride prepared by granulating a low-melting material as a nuleus and having improved sustained release effect as well as excellent external appearance, strength, stability, etc., without requiring careful dose control. CONSTITUTION:A sustained release granular material of procainamide hydrochloride (PA) obtained by heating a mixture of PA powder, preferably having <=1,000mu particle diameter with a powdery or granular low-melting material (30-100 deg.C, particularly 50-80 deg.C melting point) while flowing, applying the mixture to the PA powder in a melting process of the low-melting material to give crude PA granule (normally 9-32 mesh size) and further applying talc in an amount of 0.05-0.7pts.wt. based on 1pts.wt. above-mentioned granule to the granule. In applying the talc, the addition of light silicic acid anhydride permits the control of elution of the PA. If an enteric coating base is added, the application of the talc becomes smoother to afford a denser coat.
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