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首页> 外国专利> USE OF HIGHLY PURE SAFINAMIDE AND RALFINAMIDE FOR TREATMENT OF DISEASES AND DISEASED STATES IN CONDITIONS THAT DO NOT SUPPRESS ACTIVITY OF CYP450 SYSTEM CYTOCHROMES AND DO NOT MANIFEST BLOCKING PROPERTIES IN RESPECT OF HERG CHANNEL

USE OF HIGHLY PURE SAFINAMIDE AND RALFINAMIDE FOR TREATMENT OF DISEASES AND DISEASED STATES IN CONDITIONS THAT DO NOT SUPPRESS ACTIVITY OF CYP450 SYSTEM CYTOCHROMES AND DO NOT MANIFEST BLOCKING PROPERTIES IN RESPECT OF HERG CHANNEL

机译：在不抑制CYP450系统细胞色素活性且不显示关于Herg通道的阻滞性的情况下，使用高纯度的SAFINAMIDE和RALFINAMIDE治疗疾病和疾病

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摘要

The present invention relates to the field of pharmaceutics and concerns the application of highly pure safinamide (a) or ralfinamide (b) or a pharmaceutically acceptable acid salt thereof, wherein the content of respective impurity of (S)-2-[3-(3-fluorobenzyl)-4-(3-fluorobenzyloxy)benzylamino]propanamide (IIa) or (S)-2-[3-(2-fluorobenzyl)-4-(2-fluorobenzyloxy)benzylamino]propanamide (IIb) or a pharmaceutically acceptable acid salt thereof is lower than 0.03% by mass for production of a medicinal preparation for the treatment of, respectively: (a) epilepsy, Parkinson's disease, Alzheimer's disease, depression, jimmy-legs syndrome and migraine, or (b) diseased states including chronic pain and neuropathic pain, migraine, bipolar disorders, depressions, cardiovascular, inflammatory, genitourinary, metabolic and gastroenteric disorders in conditions that do not suppress activity of CYP450 system cytochromes and do not manifest blocking properties in respect of HERG channel. The invention also relates to a pharmaceutical formulation comprising said compounds and designed for the treatment of said states, and to a method for the treatment of said states using said highly pure safinamide or ralfinamide, or a pharmaceutically acceptable acid salt thereof. The claimed invention makes it possible to provide higher safety of the treatment of the above-listed states using safinamide- and ralfinamide-based medicines, and to extend the possibility of such treatment to groups of patients for which it was inaccessible earlier.
机译：本发明涉及药物领域，涉及高纯度沙非酰胺（a）或雷非酰胺（b）或其药学上可接受的酸盐的应用，其中（S）-2- [3-（ 3-氟苄基）-4-（3-氟苄氧基）苄基氨基]丙酰胺（IIa）或（S）-2- [3-（2-氟苄基）-4-（2-氟苄氧基）苄基氨基]丙酰胺（IIb）其可接受的酸盐的质量低于0.03质量％，用于生产分别用于治疗以下疾病的药物制剂：（a）癫痫，帕金森氏病，阿尔茨海默氏病，抑郁症，吉米斯腿综合征和偏头痛，或（b）患病状态包括慢性疼痛和神经性疼痛，偏头痛，双相情感障碍，抑郁症，心血管疾病，炎性疾病，泌尿生殖系统疾病，代谢疾病和胃肠道疾病，且这些疾病不会抑制CYP450系统细胞色素的活性，也没有表现出针对HERG通道的阻断特性。本发明还涉及包含所述化合物并设计用于治疗所述状态的药物制剂，并且涉及使用所述高纯度的沙非酰胺或雷非酰胺或其药学上可接受的酸盐治疗所述状态的方法。所要求保护的发明使得可以使用基于沙非酰胺和拉非酰胺的药物提供更高的安全性，并且可以将这种治疗的可能性扩展到较早无法获得的患者群体。

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