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随着我国药品专利法实施和“复关”的临近,国内对中药新药的研究与开发达到了前所未有的高潮,极大地促进了中医药的发展,并取得了举世瞩目的成绩。但同时也存在不少问题,多数新药市场生命周期较短,低水平重复现象较严重。笔者现就以下几方面谈一谈自己的体会和认识,以便与同行商榷。1 中药新药的选方 选方是中药新药研究与开发的第一步,也是中药新药能否开发成功的关键。一个新药是否有效,是否具有强大的生命力和市场竞争力,很大程度上取决于选方是否精当。因此,在选方过程中以下几点值得注意。 第一,系统整理传统及现代中医药文献,广泛收集
With the imminent implementation of China’s drug patent law and the “re-entry”, domestic research and development of new Chinese medicine drugs has reached an unprecedented culmination, which has greatly promoted the development of Chinese medicine, and has achieved remarkable results. However, there are also many problems. The life cycle of most new drug markets is short, and the low-level repeat phenomenon is more serious. The author is now talking about his own experience and understanding in the following aspects so that he can discuss with his peers. 1 Selection of new drugs for traditional Chinese medicines Party selection is the first step in the research and development of new Chinese medicines and it is also the key to the successful development of new traditional Chinese medicines. Whether or not a new drug is effective, whether it has strong vitality and market competitiveness depends to a large extent on whether the selected party is appropriate. Therefore, the following points are worth noting in the selection process. First, systematically collate traditional and modern Chinese medicine literature and widely collect