“以患者为中心”是医药相关领域共同遵循的理念。结合中药新药药学研究与评价相关问题的思考与实践，从“以患者为中心”的角度出发，对中药新药的药学研究如何满足患者需求进行了探讨，建议：（1）加强药材中外源性污染物及药品中内源性有毒成分等的质量控制，保证患者用药的安全性；（2）加强原辅料、生产过程、包装贮藏、质量标准等中药生产全过程的质量控制，保持不同批次药品质量的稳定，保证患者用药的有效性；（3）建立新药研究相关指导原则体系、鼓励中药创新研发、保持资源可持续利用，保证患者对于创新中药的可及性；（4）规范中药说明书【处方】【规格】【贮藏】等项的药学信息，提高患者用药的便利性。“以患者为中心”的理念对于中药新药的药学研究具有较好的指导作用。

Patient-focused is a common concept in medicine related fields. Combined with thinking and practice of pharmaceutical research related to new traditional Chinese medicine (TCM), how to meet the needs of patients in the pharmaceutical research of new TCM from the perspective of "patient-focused" were discussed in this paper. It is suggested that:(1) the quality control of exogenous harmful contaminants and endogenous toxic components in medicinal materials should be strengthened to ensure the medication safety of patients. (2) Relevant information such as medicinal materials and excipients, production process, storage, package and specifications, should be studied to ensure the stability of the quality of different batches of new TCM, so as to ensure the medication effectiveness of patients. (3) The guideline system of new drug research should be established, the innovative research and development of new TCM should be encouraged, and the sustainable utilization of resources should be guaranteed to ensure the accessibility of patients to innovative TCM. (4) The pharmaceutical information of[prescription],[specification],[storage] and other items in the labelling of TCM should be standardized to ensure that it is convenient for patients to use drugs rationally. The concept of "patientfocused" has a good guiding role for the pharmaceutical research of new TCM.

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