| 摘要 |
A novel process for preparing a stable granulate, which comprises a mixture of amoxicillin trihydrate and amoxicillin sodium, by means of extrusion granulation of amoxicillin trihydrate with an aqueous solution of sodium hydroxide, sodium bicarbonate, sodium carbonate and mixture thereof or with an aqueous solution of sodium salt of (C<SUB>1-8</SUB>) organic acid as a sodium source to form a moist extruded mass, which is granulated through a sieve and dried the obtained granulate, is disclosed. Alternatively, a novel process for preparing a stable granulate comprising pure amoxicillin sodium may be obtained according to the above extrusion granulation process as well. In a further aspect the present invention relates to a novel stable granulate comprising the mixture of amoxicillin trihydrate and amoxicillin sodium or alternatively, to a novel stable granulate comprising pure amoxicillin sodium, whenever prepared according to the above described process. Novel granulate of the present invention may be used for reconstitution with water into aqueous suspension, for parenteral injection administration, for preparing solid dosage forms, e.g. tablets, dispersible tablets, capsules, chewable tablets, and is used for treating bacterial infections in humans or animals.
|
