| 摘要 |
<p>A process for the industrial manufacture in an aqueous medium of a slow-release excipient consisting mainly of cross-linked amylose having controlled release properties, for use in the preparation of tablets or pellets. A starch containing a high amount of amylose (high amylose starch) is first subjected to a gelatinization. The gelatinized high amylose starch is then cross-linked with 1 to 5 g of a cross-linking agent per 100 g of dry-based gelatinized high amylose starch in an alkali medium, thereby forming a reaction medium containing a reaction product consisting of a cross-linked high amylose starch slurry. The obtained reaction medium is neutralized, thereby forming by-products mainly consisting of salts, which are removed from the reaction medium. The recovered cross-linked high amylose starch slurry is then subjected to a thermal treatment at a temperature of at least 60 °C and the thermally treated product is dried to obtain the requested slow release excipient. This process is economical and industrially advantageous since it is carried out in an aqueous medium.</p> |
