abstract |
The present invention relates to a sustained release preparation containing 100-1000mg acetamidophenol and 15-150mg tramadol in its unit dosage. The unit dosage includes (1)fast release part cantaining 2575% of total active principle; (2) sustained release part containing (a) 2575% of total active principle; and (b) 6-50% of colloidal polymer, as the prepation's total weight; and optionally containing (c) 5-40% of enteric coating. In first hour, said prepation's release amount is 25-60% of the total realse amount, and in first four hours, the release amount is not less than 80%, accoding to USP dissolution test II, under the condition of 50rpm. |