中药临床再评价的特殊性

Specificity of traditional Chinese medicine's clinical re-evaluation

临床再评价是重复验证药物的安全性与有效性,药物本身没有改进和提高。但是由于中药成分复杂,在原料药、处方、生产工艺、质量标准等方面都还有待提高,对于中药临床再评价来说不能缺少改进药物质量、提高安全性、有效性的要求。因此,中药临床再评价在达到西药再评价的那些基本要求外,还应该对中药本身有所提高,要充分重视中药特殊性,使中药临床再评价发挥应有的作用。

Clinical re-evaluation is to verify the drug＇s safety and effectiveness again,while the drug itself has not been improved. However, due to the complexity of traditional Chinese medicine, ingredients in bulk drugs, prescription, productive processes, quality standards and other aspects need to be enhanced. So improving the quality, safety and effectiveness of traditional Chinese medicine by clinical re-evaluation is also very necessary. Therefore, except for achieving those basic requirements of medicine, it should also be improved on itself and pay full attention to the particularity, then traditional Chinese medicine＇s clinical re-evaluation will play its due role.