Objective To investigate the selection of penetration enhancers for the tablet core of Morphine Hydrochloride Osmotic Pump Tablets.Methods With the drug release behavior in vitro as an index,the single factor test was used to investigate the types and dosages of osmotic pressure active substances,disintegrants,and polymer,and validation tests were conducted according to the optimization results.Results The osmotic pressure active substance in the tablet core prescription of Morphine Hydrochloride Osmotic Pump Tablets was 60%lactose,without the addition of disintegrants or high molecular weight polymers,which met the sustained release law of the product.The release curve of three batches of semi-permeable film-coated tablets prepared according to the prescription process was good,and there was no significant change in the cumulative release in vitro under the accelerated stability test.Conclusion The 20-hour release of Morphine Hydrochloride Osmotic Pump Tablets was more than 85%when 60%lactose was selected as the penetration enhancers for the tablet core of Morphine Hydrochloride Osmotic Pump Tablets,and the quality of the product was stable.
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