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天然产物中获取的一些具有希望的化合物或候选药物,有些表现为多组分的协同效应,而非单一化合物的作用。在某些情况下,化合物纯化后,不但活性不理想,而且常显示明显的毒性或不良反应。因此,研究具有协同增效或减毒的天然产物组合物,在药物研发中具有重要意义。知识产权保护是明确药理效应后的首要任务。天然产物活性成分复杂,使其保护更加困难。我国生产的七叶皂苷是一类从中华七叶树和天师栗种子提取的三萜皂苷,具有抗炎、抗水肿作用。原七叶皂苷制剂不良反应多,应用受到限制。“低毒的抗炎抗渗出药物组合物”发明专利,优化了通式Ⅰ和Ⅱ七叶皂苷的比例,保持了抗炎、抗水肿活性,降低了毒性和刺激性。文中以该专利为代表,论述如何实现天然药物的知识产权保护及其意义。
Some of the promising compounds or candidate drugs obtained in the natural product, some appearing as a multi-component synergistic effect, rather than a single compound. In some cases, after the compound is purified, not only is the activity unsatisfactory, but it often shows obvious toxicity or adverse reactions. Therefore, the study of synergistic or attenuated natural product compositions is of great significance in drug development. The protection of intellectual property rights is the primary task after clarifying the pharmacological effects. The complex of natural product active ingredients makes it more difficult to protect. Aesculin produced in China is a triterpenoid saponin extracted from Chinese chestnut and Tianshi chestnut seeds, which has anti-inflammatory and anti-edema effects. The original Aescin saponin preparation has many adverse reactions and its application is limited. “Low-toxic anti-inflammatory and anti-bleeding pharmaceutical composition ” invention patent, optimized the proportion of aesculin I and II, maintained anti-inflammatory, anti-edematous activity, reduced toxicity and irritation. In this article, the patent is used as a representative to discuss how to realize the protection of intellectual property of natural medicines and its significance.