中成药剂量是决定其临床有效和安全的重要因素，但目前对中成药剂量的分析研究较少。通过对《中国药典》2015年版919个中成药及其药味剂量进行统计分析，结果显示药典收载中成药处方中大部分药味日服饮片量小于药典单味饮片用量，且无论是其处方中单味药的日服剂量还是处方日服总剂量，均远小于中医临床汤剂常用剂量。对中药有效方剂成药化过程中影响中成药剂量的相关问题进行了探讨，提出在由临床有效方剂转化为中成药的新药研究中，应充分重视临床有效方剂的药味剂量，注重量效关系研究，以"质量源于设计"的理念，研制高质量中成药，以体现、发挥原有方剂的疗效。如何在原临床有效剂量的基础上制定新药剂量，是中药临床有效方剂成药化研究中需关注和解答的问题。

Dosage is an important factor that affect clinical efficacy and safety of Chinese patent medicine, however, less study has been done on the analysis of dosage in Chinese patent medicine. Through the statistical analysis for dosage of 919 Chinese patent medicines in Chinese pharmacopoeia (2015 edition), it is found that the daily dose of most medicinal herbal pieces in Chinese patent medicines is less than the dose of single herbal medicine in the pharmacopoeia; And both the daily dose of single herbal medicine and the total daily dose of prescriptions are less than the commonly used dosage of decoctions in clinic. By exploring and discussing the related problems that affecting the dosage of Chinese patent medicine in the process of transformation from clinical effective prescription to Chinese patent medicine, this paper presented we should pay more attention to clinical effective dosage, strengthen the research of dose-effect relationship in the study of new traditional Chinese medicine from clinical effective prescription, and design and research high-quality Chinese patent medicine based on "quality by design, QbD" concept to reflect and exert the efficacy of original prescription. How to determine the dosage of new traditional Chinese medicine on the basis of clinical effective dosage is a question that needs to be concerned and answered.