Abstract: Chinese patent medicine is a modern dosage form of traditional Chinese herbal formula, which confrom to the inheritance and innovation of traditional Chinese medicine (TCM). How to identify substance-related-effects and control the quality of the products is the most critical issue in the manufacturing process of Chinese patent medicine including exctraction, purification, concntration, drying. According to the R&D pratice for many years, "substance-related-effects" are put forward and regarded as indicator to build the Quality Control of the production process, hoping to obtain perfornance products with reliable effects and consisten quality.