山东新华制药股份(00719.HK)全资子公司获得药品注册证书
格隆汇 3 月 8日丨山东新华制药股份(00719.HK)公布,近日,公司全资子公司—山东淄博新达制药有限公司("新达制药")收到国家药品监督管理局核准签发的乳酸菌素颗粒(1g)和乳酸菌素颗粒(2g)《药品注册证书》,该产品通过新产品注册审评("新产品注册")。
据悉,乳酸菌素为脱脂牛乳发酵处理后,由乳酸菌在代谢过程中通过核糖体合成机制产生的一类具有抑菌活性的多肽、蛋白质或蛋白质复合物,除此之外还有乳糖、半乳糖、乳酸、矿物质,尚有微量的卵磷脂、胆固醇、柠檬酸、色素、气体、维生素和酶等营养物质。它可在肠道形成保护层,通过四种作用机制阻碍病原菌、病毒对机体的侵袭:一是刺激肠道分泌抗体、提高肠道免疫力;二是选择性杀死肠道致病菌,保护促进有益菌的生长;三是调节肠黏膜电解质、水分平衡;四是促进胃液分泌,增强消化功能。临床上主要用于肠内异常发酵,消化不良,肠炎和小儿腹泻等,本品为OTC乙类药品,多年以来应用证明,乳酸菌素疗效确切、安全性好,获得广大患者的好评。
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