山河药辅:新增1种药用辅料产品甘露醇丸芯

Core Viewpoint - The announcement by the company regarding the addition of a new pharmaceutical excipient product, Mannitol Core, is expected to positively impact the company's operations in the coming years [2]. Group 1: Product Details - The newly added product, Mannitol Core, has received the registration number F20250000241 from the National Medical Products Administration [1]. - As of the announcement date, the company has a total of 47 products with CDE registration numbers [1]. - Mannitol Core is a white or off-white spherical pellet made from D-mannitol and other excipients, primarily used as a carrier for enteric-coated micro-pellets and controlled-release micro-pellets [1]. Group 2: Product Features - Mannitol Core serves as an ideal platform for drug layering due to its smooth surface and uniform particle size distribution, ensuring even and secure drug layering [1]. - It acts as an inert core for preparing controlled-release micro-pellets, allowing the release characteristics to be primarily controlled by the coating membrane [1]. - The product improves taste, as mannitol has a cooling sweetness and produces a cooling sensation upon dissolution [1]. - It enables the preparation of compound formulations, allowing different drugs to be loaded onto separate batches of Mannitol Core, thus avoiding incompatibility between different drug components and achieving varied release rates [1]. - Mannitol Core can also be used directly as an osmotic diuretic [1].