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山河药辅:新增1种药用辅料产品甘露醇丸芯
Cai Jing Wang· 2025-08-04 10:04
8月4日,山河药辅发布关于公司新增产品品种的公告。披露近日公司新增 1 种药用辅料产品:甘露醇丸 芯获得国家药品监督管理局药品审评中心的登记号,为 F20250000241。截止公告日,山河药辅已有 47 种产品获得 CDE 登记号。 3.改善口感:甘露醇本身具有清凉的甜味,溶解时吸热产生清凉感; 4.制备复方制剂:不同药物可分别载到不同的甘露醇丸芯批次上,可以避免不同药物成分之间的物理化 学不相容,实现不同药物不同的释放速度; 5.可直接作为渗透性利尿药使用。 公司新增产品品种,扩大了公司产品生产范围,将对公司后续年度的经营产生一定的积极影响。 (企业公告) 甘露醇丸芯是由 D-甘露糖醇及其他辅料制成的白色或类白色球形小丸,主要用作肠溶微丸制剂和缓控 释微丸制剂的载体,也可直接作为药物微丸。具有以下特点: 1.作为药物层积的载体:甘露醇丸芯表面光滑、规则,粒径分布均一,为药物层积提供了理想的起始平 台,确保药物层均匀、牢固; 2.制备缓控释微丸:甘露醇丸芯作为惰性核心,不影响药物的释放行为,使得释放特性主要由包衣膜控 制; ...
山河药辅新增1种药用辅料产品
Zhi Tong Cai Jing· 2025-08-04 08:42
山河药辅(300452)(300452.SZ)公告,公司新增1种药用辅料产品:甘露醇丸芯获得国家药品监督管理 局药品审评中心(简称"CDE")的登记号,为F20250000241。甘露醇丸芯是由D-甘露糖醇及其他辅料制成 的白色或类白色球形小丸,主要用作肠溶微丸制剂和缓控释微丸制剂的载体,也可直接作为药物微丸。 ...
山河药辅(300452.SZ):新增1种药用辅料产品
Ge Long Hui A P P· 2025-08-04 08:40
Core Viewpoint - Shanhe Pharmaceutical Excipients Co., Ltd. has recently received a registration number for a new pharmaceutical excipient product, Mannitol Pill Core, from the National Medical Products Administration (NMPA) [1] Company Summary - Shanhe Pharmaceutical Excipients has a total of 47 products that have received registration numbers from the NMPA as of the announcement date [1] - The newly registered Mannitol Pill Core is made from D-mannitol and other excipients, and is primarily used as a carrier for enteric-coated micro-pellets and sustained-release micro-pellets, and can also be used directly as a drug micro-pellet [1]
山河药辅(300452.SZ)新增1种药用辅料产品
智通财经网· 2025-08-04 08:39
Core Viewpoint - The company Shanhe Pharmaceutical Auxiliary (300452.SZ) has announced the registration of a new pharmaceutical excipient product, Mannitol Core, with the National Medical Products Administration (NMPA) [1] Group 1 - The newly registered product, Mannitol Core, has the registration number F20250000241 [1] - Mannitol Core is composed of D-mannitol and other excipients, characterized as white or off-white spherical granules [1] - The primary applications of Mannitol Core include serving as a carrier for enteric-coated microgranules and sustained-release microgranules, and it can also be used directly as a drug microgranule [1]